Portable Magneto-Optical Device can Detect Malaria Rapidly

A portable, magneto-optical device that rapidly detects the early stages of malaria infection has been created by Andrea Armani of the University of Southern California and colleagues. It analyses blood samples by moving magnetic nanocrystals created by the parasite away from a laser beam, detecting changes in the light passing through the sample if the magnetic substance is present. The scientists say this technique allows them to identify early changes in the blood of someone infected with malaria, regardless of the parasite strain.

Malaria is a major global health problem. In 2016 there were an estimated 216 million cases in 91 countries, resulting in 445,000 deaths, according to the World Health Organization. Most of the burden of this mosquito-borne infectious disease, caused by Plasmodium parasites, falls on the developing world. In 2016 Africa was home to around 90% of malaria cases and deaths.

Early diagnosis is key to effective malaria treatment and helps reduce transmission. The two most common tests are microscopy and antibody-based diagnostic tests, but both have their limitations. Identifying malaria-causing parasites in blood samples using a light microscope is the diagnostic standard, but this can be slow, and it relies on good-quality equipment and well-trained technicians. Poorly done microscopy is a well-known problem in malaria diagnostics.

Rapid diagnostic tests (RDT) detect malaria antigens in a small sample of blood placed on a test strip, giving results in around 15 min. There are many different RDTs, however, and they vary in quality and some ideally need to be kept refrigerated. Also, most do not test for all strains of malaria – they target different antigen combinations depending on the local epidemiology.

Magnetic byproduct

Armani and colleague’s magneto-optical device detects haemozoin – a by-product created by all species of malaria parasite. The team says by focusing on haemozoin, their test can rapidly detect the early stages of infection for all malaria strains.

The prototype, described in ACS Sensors, can detect levels of a haemozoin mimic in rabbit blood that correspond to around 26 parasites/μL. According to the researchers, this is below the level at which there would be symptoms of disease, and comparable to, or better than, current malaria tests.

The device is the size of a shoebox, weighs less than 5 kg and can be powered by a battery for 8 h. It also works with whole blood samples without the need for added chemicals, which may have strict storage requirements. The researchers say that these attributes make it ideal for use in low-resource environments.

“All of my research is funded by the military, so my lab takes a very different approach to designing diagnostic systems,” Armani explains. “We design with the goal of making instruments that can be dropped from planes, operated with minimal power and are very lightweight.”

Haemezoin is produced when the malaria parasite digests haemoglobin, a component of red blood cells and its primary nutrient source. As the parasite feeds on haemoglobin it creates haem, an iron-containing compound that is toxic to the parasite. To tackle this, the parasite converts haem into an insoluble crystalline form called haemozoin. This substance is a prime target for a magneto-optic diagnostic system because it is good at blocking light. It is not usually present in blood and crucially, unlike all other components of blood, it is magnetic.

Pulled to one side

The device comprises a laser, a light detector and a magnet. When a blood sample is placed in the device, the detector measures how much light from the laser passes through the blood. The magnet is then switched on and if haemozoin is present it is pulled out the laser beam. This causes the amount of light reaching the detector to increase.

Armani told Physics World that the team is now looking to reduce the sample volume required for the test from 5–7 drops of blood to 1–2 drops. This would allow finger prick testing, as well as working on further trials as a precursor to field tests.

“The current prototype demonstrated can detect early-stage infection,” Armani says. “Conservatively, the earliest part of the early-stage infection window begins 48–72 h after infection. However, our ultimate goal is to detect within the first 24–48 h.”

This is not the first time that a magneto-optical malaria detector has been proposed. In 2014 physicists in Hungary developed a prototype that used a somewhat different detection process.

Source: Physics World

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Univ. of Florida Team Develops Airborne Flu Detection Device

This past flu season was one of the worst in nearly a decade. The virus killed 160 children in a national epidemic and thousands more were hospitalized, according to the Centers for Disease Control and Prevention.

New technology under development at the University of Florida in Gainesville could change future flu seasons by detecting the virus faster.

Dr. Chang-Yu Wu and a team of researchers have developed a first-of-its-kind air sampler to detect the tiny influenza virus in the air in public spaces.

The large black box sounds similar to a quiet vacuum when it's turned on. The device sucks in frequent air samples.

Water vapors then attach to tiny virus particles found in the air, making the virus bigger and easier to detect.

The air samples can determine if the flu or other small viruses, such as measles, are floating around in public places like an airport.

"Virus aerosol is responsible for a lot of diseases," said Dr. Wu.

The air sampler would alert public officials to the presence of the virus, who could then alert to public to the risk.

Wu said by informing people, they are able to take precautions to prevent the flu virus from spreading to them. Spotting viruses early could mean the difference between a small outbreak and a pandemic.

"I envision in the future, we can make more portable, smaller ones," said Dr. Wu.

He sees the device one day expanding to the battlefield. Dr. Wu said the air sampler could be used to detect bio-terrorism threats and alerting U.S. soldiers on the front line to the danger.

Dr. Wu has tested the air sampler in student centers around the UF campus. His results have shown that the flu virus can spread from an infected person to others just walking by more than 6 feet away.

The device is still in the testing phase.

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False-Negative Rapid Flu Test Results Delay Treatment Decisions

Negative rapid influenza antigen test results can delay the initiation of antiviral medication for patients with influenza who are critically ill, according to findings presented at ASM Microbe.

“The CDC recommends antiviral treatment as early as possible for people who are very sick with the flu, or who are at high risk of serious complications based on their age or health if they develop influenza,” said Kristen Nordlund, CDC press officer.

However, rapid influenza antigen tests (RIATs) are the only influenza test available at the point of care, and their high rate of false-negative results can potentially delay treatment in patients who are critically ill, researchers said. Preparing for the H1N1 epidemic in 2009, Po-Yen Huang, MD, of the Chang Gung Memorial Hospital in Taoyuan, Taiwan, and colleagues began initiating influenza PCR and virus culture in conjunction with RIAT at their institution. The researchers retrospectively analyzed cohort data from 307 patients admitted to the ICU with laboratory-confirmed influenza from August 2009 to July 2017 to gauge the impact of RIATs on those who were severely ill with influenza.

RIATs were conducted for 259 cases, and about half (49%) were negative. Additional PCR testing was done in 99 of the 126 negative samples, and almost all of these (99%) were positive by PCR, according to the researchers.

Forty-five cases (15%) could not be confirmed by testing upper respiratory tract samples, and researchers said the diagnosis relied instead on testing samples from the lower respiratory tract.

“Lower respiratory tract samples are of importance for diagnosis of severe influenza infection,” Huang said told Infectious Disease News. “Clinicians need to send lower respiratory tract specimens for testing when concerned about influenza infections in appropriate settings.”

They found that patients whose RIAT was negative had a longer stay in the ICU, with a median of 12 days vs. 9 days for those who received a positive RIAT result. They found that treatment was significantly delayed for patients with a negative RIAT, and antiviral medication was not initiated for a median of 1 day vs. same-day treatment for patients with a positive RIAT (P = .01).

Huang and colleagues suggested that physicians are less likely to administer antiviral medication to patients with a negative RIAT, and for critically ill patients with influenza, a negative RIAT can complicate and prolong clinical outcomes compared with the outcomes of a positive test.

“Proper interpretation of a RIAT result is needed for clinical management of hospitalized patients with suspected influenza infection,” Huang said. “Decision-making based on RIAT is strongly discouraged, and prompt empiric antiviral medication is justified in severe respiratory infection.” – by Marley Ghizzone

Reference: Huang PY, et al. Abstract 701. Presented at: ASM Microbe 2018; June 7-11, 2018; Atlanta.

Disclosures: Nordlund works for the CDC. Huang reports no relevant financial disclosures.

Source: Healio Infectious Disease News

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UTSA Researchers Create Method that can Quickly and Accurately Detect Infections

A new study by Waldemar Gorski, professor and chair of the UTSA Department of Chemistry, and Stanton McHardy, associate professor of research in chemistry and director of the UTSA Center for Innovative Drug Discovery, describes a method that could show quickly and accurately whether a person has been infected with harmful bacteria or other pathogens. Additionally, this new method shows the exact severity of infection in a person.

The most common method of testing for infection in medical facilities is a strip that turns a certain color when infected fluids come into contact with it.

“The problem with this method is that it’s imprecise,” Gorski said. “The human eye is forced to judge the level of infection based on the hue and deepness of a color. It’s difficult to make an accurate call based on that.” Furthermore, roughly a third of samples cannot be tested because the fluids contain blood or are too opaque.

Other methods include microbiology or examining body fluid samples under a microscope and counting white blood cells, also known as leukocytes, which are an indicator of an infection. However, these can be slow processes and require more highly trained personnel.

Gorski, seeing a need for an easier and more rapid method of testing for infection, resolved to test an electrochemical approach, and sought out McHardy, a medicinal chemist. Together, they created molecules that bind to leukocyte enzymes and produce an electrical current to signal the presence of an infection.

Their new molecules are housed on a testing strip. After being contacted with infected bodily fluids, the strip is connected to a computer monitor that displays a clear range of electrochemical responses demonstrating the severity of an infection.

“The signs and symptoms people demonstrate aren’t always reflective of the level of the infection they have,” McHardy said. “This method could very easily show just how serious an infection is and make diagnosis a much quicker process, possibly preventing a more serious illness.”

Gorski believes the method could be especially useful to people who have just undergone surgery, as it could determine definitively whether they have an infection from the procedure before it worsens.

To date, Gorski and McHardy have filed a patent for their invention, published two papers and plan to work with an engineer in the future to streamline its design.

Read Waldemar Gorski and Stanton McHardy’s study, “Synthesis and Characterization of Pyridine Compounds for Amperometric Measurements of Leukocyte Esterase”

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T2 Biosystems Presents Data on T2Bacteria Panel for Sepsis Prevention Opportunities at ASM

T2 Biosystems, Inc., an emerging leader in the development of innovative diagnostic products for critical unmet needs in healthcare, announced late-breaker posters and data presented at the American Society for Microbiology (ASM) Microbe conference on June 7-11 that demonstrate the T2Bacteria® Panel’s accuracy and speed, which may enable more rapid treatment of patients with bloodstream infections in order to prevent sepsis. FDA clearance of the T2Bacteria Panel was announced on May 29, 2018, making the T2Bacteria Panel the first and only FDA-cleared test to identify sepsis-causing bacteria directly from whole blood.

“The strong customer data and conclusions expressed by clinicians at ASM Microbe on T2Bacteria are encouraging and allows us to further strengthen the momentum generated by FDA clearance two weeks ago,” said John McDonough, president and chief executive officer, T2 Biosystems. “We are already seeing excitement in the market, as healthcare providers recognize the potential of the T2Bacteria Panel to prevent the progression of bloodstream infections to sepsis. The ASM Microbe conference, which is one of our largest customer meetings of the year, was an important and successful step to raise awareness around the T2Bacteria Panel.”

For the first time in the U.S., the T2Bacteria pivotal clinical trial data was presented, representing a large study of over 1,400 patient samples collected across 11 hospital and hospital systems across the U.S. The investigators concluded:

• T2Bacteria demonstrated excellent accuracy, including overall sensitivity of 90% and overall average specificity of 98%.
• T2Bacteria detected 69 patient infections that were not detected by the concurrent blood culture.
• Blood culture species identification results took an average of 3 days while T2Bacteria took an average of only 5.4 hours in the clinical trial, providing results more than 2.5 days faster.
• 66% of patients in the clinical trial with a bloodstream infection confirmed by T2 and blood culture could have benefited from earlier appropriate antibiotics based on the rapid T2Bacteria result.
• T2Bacteria also had a noted advantage in detecting infected patients on antibiotics who were missed by blood culture.

“T2 panels afford clinicians the first direct from blood diagnostics for the detection of sepsis-causing pathogens,” said clinical trial investigator Cornelius J. Clancy, MD, Associate Professor of Medicine, Infectious Diseases Division and Director, Mycology Program, University of Pittsburgh; Chief of Infectious Diseases Section, VA Pittsburgh Health Care System. “Earlier species ID results from T2Bacteria and T2Candida provide critical and timely information that can aid in providing the best care for my patients. The T2Bacteria pivotal clinical trial data corroborate findings from the T2Candida Direct2 study by demonstrating the limitations of blood culture and the potential impact of the T2 platform.”

A separate evaluation of T2Bacteria by clinicians at Ochsner Medical Center found:

• T2Bacteria detected 14 infections missed by a paired blood culture – but proven to be a true infection by other cultures.
• T2Bacteria identified every infection detected by blood culture of the target species (100% sensitivity).
• T2Bacteria was highly accurate in identifying samples without an infection, with 99% average specificity.

The authors concluded that the advantages of T2Bacteria over blood culture could make it a valuable tool to enable faster time to targeted antibiotic therapy and reduced use of unnecessary antibiotics.

In a late-breaker poster from Northwestern University, clinicians found the T2Bacteria Panel was highly accurate compared to blood culture and detected 18 clinically important urinary and respiratory infections that were missed by blood culture. The authors concluded that T2Bacteria may improve patient care by providing clinicians rapid and actionable information for treating patients.

Finally, another late-breaker poster from the Centers for Disease Control and Prevention (CDC) on their validation of the Research Use Only diagnostic for the detection of the emerging superbug Candida auris, found that the T2 Magnetic Resonance (T2MR®) provided extremely accurate diagnostic results from patient skin samples. The poster concludes that T2MR could be used to provide a more rapid response to future outbreaks.

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Luminex Initiates Clinical Trials for VERIGENE II Gastrointestinal Assay

Luminex Corporation announced the company recently began clinical studies for the Gastrointestinal (GI) Assay on the VERIGENE® II System, its new sample to answer benchtop molecular diagnostic system in development.

The VERIGENE System enables clinicians to rapidly identify the pathogens responsible for some of the most complex, costly, and deadly human infectious diseases. The system offers automated, cost-effective multiplex capabilities that accurately detect infectious pathogens and drug resistance markers, without relying on time-consuming culture methods.

The VERIGENE II System contains the same core nanoparticle chemistry as the current VERIGENE System, while consolidating four individual consumables into a single cartridge within a closed system for a much simpler workflow.

The new fully automated system will support ambient temperature storage and up to six modules for random access testing at any given time.

"The VERIGENE II System is an excellent example of our commitment to innovation and to simplifying complexity in diagnostic testing," said Homi Shamir, President and Chief Executive Officer of Luminex. "The VERIGENE II System is extremely easy to use, reduces hands-on time, and offers users a great deal of flexibility. We anticipate this GI panel study will be the first of many IVD assay clinical studies to be conducted on this next-generation platform. We are also on track to begin clinical trials on our VERIGENE II Respiratory Assay later this year, followed by panels for blood culture and meningitis."

The VERIGENE II GI Assay is an automated test for the detection and identification of enteric bacteria, viruses, parasites, and toxins in stool samples. The panel has been built to include the targets identified in the recently updated Infectious Diseases Society of America (IDSA) guidelines. With less than two minutes of hands-on time and fast overall turnaround time, the GI Assay is designed to provide rapid results on a wide breadth of clinically relevant analytes for comprehensive coverage of idiopathic GI disease.

The GI panel will also feature Flex testing – a unique feature of the VERIGENE System – enabling clinicians to test and pay for only the relevant pathogens they are interested in for specific patients and geographical regions. Additional results not initially reported after test completion can be reflexed instantly at an extra cost without running an additional test. Luminex's Flex Pricing approach was designed, in part, to help customers manage through pricing pressures, such as those resulting from the Centers for Medicare & Medicaid Services' Protecting Access to Medicare Act (PAMA) and Palmetto reimbursement cuts.

The clinical study is being conducted at approximately twelve sites in the U.S. Following a successful trial, the company expects to submit the GI Assay, the first IVD test for use on the VERIGENE II System, for CE marking and FDA clearance next year.

The VERIGENE II is part of Luminex's growing portfolio of sample to answer molecular diagnostic solutions, which also includes the ARIES® Systems. The Luminex portfolio for gastrointestinal diagnostics includes the ARIES® C. difficile Assay, the VERIGENE® Enteric Pathogens Test (EP), and the xTAG® Gastrointestinal Pathogen Panel (GPP), which offers the ability to mask targets and create custom panels for patient populations.

The VERIGENE® II System is under development and not currently FDA cleared or CE Marked for IVD use.

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Optical Fiber Infrared Spectroscopy Identifies Septic vs Nonseptic Synovial Fluids

Optical fiber infrared spectroscopy is a quick and reliable method for discriminating between septic and nonseptic fluids, according to data presented at the European League Against Rheumatism (EULAR) Congress, held in Amsterdam, June 13-16, 2018.

“The [septic arthritis] diagnosis is based on the cytobacteriological examination of the synovial fluid, but direct bacteriological examination is insensitive and the result of the culture is obtained only after several days,” the researchers explained. “Therefore, there is still a need for a rapid, simple, and reliable method for the positive diagnosis of septic arthritis. Such method must allow avoiding both unrecognized septic arthritis leading to major functional consequences, and overdiagnosis that will induce unnecessary expensive hospitalization and unjustified treatment with consequences in term of health and social costs.”

The purpose of the study, according to the investigators, was to verify the interest of mid-infrared spectroscopy to identify synovial fluid samples from patients with septic arthritis vs other causes of joint effusion. A total of 402 patients with suspected arthropathies were enrolled in the study. Investigators obtained synovial fluids from each patient and used a chalcogenide fiber sensor to acquire the infrared absorption spectrum from each sample. Spectral variables, which allowed determination of septic and nonseptic arthritis, were used to develop an algorithm that was later validated with non-frozen synovial fluids from a different research center.

Researchers used 16S polymerase chain reaction analysis and a synovial fluid bacteriologic analysis and culture to classify synovial fluid samples as having septic arthritis (n=30) or nonseptic arthritis (n=372). A sensitivity of 97% and specificity of 71% were observed for the developed algorithm. Additionally, investigators found a positive predictive value of 21% and a negative predictive value of 99% for the algorithm (area under the curve, 0.91).

“The high negative predictive value and the very short time (about 10 minutes) required to obtain the result makes it possible to quickly rule out an infection diagnosis, which could make it possible to avoid unnecessary hospitalization and antibiotic therapy,” the researchers concluded.

Reference

Albert JD, Le Corvec M, Martin A, et al. Septic arthritis screening with a fast diagnostic tool using mid infrared spectroscopy: a multi-centric study. Presented at: European League Against Rheumatism (EULAR) Congress 2018; June 13-16, 2018; Amsterdam, The Netherlands. Abstract FRI0642.

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GenomeDx Biosciences and Pathnostics Launch Enhanced Version of Pathogen Guidance Tests

GenomeDx Biosciences and Pathnostics today announced the launch of the next generation Guidance testing for patients suffering from simple cystitis, recurrent, persistent or complicated urinary tract infections (UTI), prostatitis and interstitial cystitis (IC). The Guidance test is performed by Pathnostics and distributed by GenomeDx to urologists. This molecular test expands GenomeDx's commercially available solutions for the urology market.

Guidance is a rapid diagnostic test that helps personalize treatment options through the swift identification of 42 pathogens followed by antibiotic sensitivity for the collection of identified pathogens, and this next generation of Guidance adds the evaluation of the presence of antibiotic resistant genes. This dual, patent-pending approach to antibiotic sensitivity is believed to provide more reliable information than traditional urine culture with respect to the evaluation of treatment options for patients with polymicrobial (multiple pathogens) infections and/or infections with slow growing pathogens. Further, results are available 24-48 hours after a patient's specimen arrives to the lab.

"GenomeDx is committed to leveraging genomic information to transform and improve patient care," said Edwin Hendrick, chief commercial officer of GenomeDx. "In addition to our proprietary Decipher tests for prostate and bladder cancers, we are excited to offer this enhanced version of Guidance for urologic infections."

"We value our partnership with GenomeDx to bring this unique product to the urology marketplace," said David Pauluzzi, chairman of Pathnostics. "Our proprietary technology, combined with testing at our CAP-accredited, CLIA-certified laboratory in Irvine, California, provides a faster, more comprehensive solution for urologists and their patients."

"Relying on standard urine cultures to diagnose chronic urologic infections has significant disadvantages, such as failing to consistently detect polymicrobial infections. In contrast, Guidance is a novel molecular and antibiotic sensitivity test that we believe can point the way to the best therapeutic options, thereby potentially providing more favorable patient outcomes and, in the big picture, lower healthcare costs," said David Baunoch, PhD, chief scientific officer of Pathnostics. "Detecting resistance genes, paired with our present-day antibiotic sensitivity testing, makes Guidance an ideal diagnostic tool for physicians in their efforts to rapidly determine the best treatment option for their patients and be good stewards of antibiotics."

About Guidance 

Guidance is a commercially available molecular diagnostic test that detects 42 microbial organisms associated with chronic urologic infections, determines antibiotic sensitivity, and identifies the resistance genes to determine the susceptibility of the infection to antibiotics considered for treatment. Guidance is indicated for patients with recurrent or persistent UTI infections, patients with complicated UTIs, patients experiencing symptoms of a UTI who are immunocompromised, patients with prostatitis and patients with interstitial cystitis.

According to Pathnostics' studies, traditional urine culture, as compared to Guidance, fails to identify as many causative agents in two out of three UTIs, does not detect the presence of many causative agents of prostatitis, and often fails to detect polymicrobial infections. Guidance can detect more than one causative agent of both UTIs and prostatitis, utilizing polymerase chain reaction (PCR) to detect and quantitate microbial organisms in urine specimens. Following detection, antibiotic susceptibility is derived through a proprietary high-throughput spectrophotometric assay. Guidance reports provide physicians with a list of antibiotics most likely to resolve the infection, regardless of the number of causative agents.

About GenomeDx Biosciences

GenomeDx is reimagining the use of genomics as a platform for mass collaboration to improve patient treatment and outcomes through its currently available genomic tests for prostate and bladder cancer as well as potential future tests. GenomeDx has offices in Vancouver, British Columbia and San Diego, California.

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Detection of Other Viral and Bacterial Diseases Eyed After Dengue Diagnostics Kit

After developing the international award-winning rapid dengue diagnostic kit,  local infectious disease expert Dr. Raul Destura and his team of researchers are now developing technologies for the fast detection of other deadly diseases.

Destura, who formed biotechnology startup Manila HealthTek Inc. to market the Biotek-M Dengue Aqua Kit that can diagnose dengue within an hour, said his team has been working on the expansion of the “Lab in a Mug” diagnostic technology to also provide an affordable diagnostic kit to detect other viruses and disease-causing bacteria with the next initial batch focused on chikungunya, zika virus, schistosomiasis and salmonella.

He said they target to provide a diagnostic kit for 11 viruses and bacteria with the next batch of diseases being tuberculosis, TB rifampicin resistance, influenza, hepatitis-B, malaria and HIV (human immunodeficiency virus).

“That’s why we call it Lab in a Mug. It’s just one mug but it can detect multiple infectious diseases,” Destura, a microbiologist and infectious disease specialist also working for the UP Manila National Institutes of Health and the Institute of Molecular Biology and Biotechnology, told The STAR.

Like the Biotek-M Dengue Aqua Kit, the other diagnostic kits will also be affordable for use in hospitals and eventually in barangay health centers.

Destura said his team is working to upgrade the dengue kit to allow its use even in barangay health centers.

The Biotek-Dengue Aqua Kit is being rolled out in some 60 government hospitals in Regions 1, 3 and 6, in a pilot project being conducted by the Department of Health which purchased some P21 million worth of the kits.

The Biotek-M Dengue Aqua kit was one of two Filipino-developed inventions that bagged a gold medal at the 46th International Exhibition of Inventions in Geneva, Switzerland. It is an affordable rapid diagnostic kit that uses the polymerase chain reaction technology to detect the virus in less than an hour.

Destura, a member of the Department of Science and Technology-National Research Council of the Philippines, received funding grants from the DOST Grants-in-Aid program, Philippine Council for Health Research and Development and Technology Innovation for Commercialization Technicom.

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PATH Partners with SD Biosensor to Advance Diagnostic Test for Malaria

PATH announced a new partnership with south Korean company SD Biosensor to support the development and availability in key markets of a new diagnostic intended to support malaria elimination efforts. PATH and SD Biosensor developed the STANDARD G6PD Test to guide appropriate clinical care of patients with Plasmodium vivax malaria who also have a hereditary enzyme deficiency that can lead to severe anemia if the patient receives treatment with 8-aminoquinoline-based drugs to cure the infection.

P. vivax malaria is common in Asia, Latin America, and the horn of Africa, and the World Health Organization (WHO) estimates two and a half billion people worldwide are at risk of infection. It is also known as relapsing malaria, causing recurring bouts of illness unless a patient receives treatment to kill parasites in the liver, known as radical cure. Without radical cure, the cycle of P. vivax transmission can continue in a community, which threatens efforts to completely eliminate the disease. However, patients with a condition known as glucose-6-phosphate-dehydrogenase (G6PD) deficiency can become seriously ill if given radical cure with an 8-aminoquinoline-based drug.

WHO recommends that patients be tested for G6PD deficiency before radical cure is administered. Currently available rapid tests for G6PD deficiency do not adequately determine the G6PD status of women who carry the gene for G6PD deficiency on only one X chromosome and have intermediate G6PD activity levels. Current tests that provide this level of determination of G6PD activity in women are too expensive and complex for use at the point of care in low-resource settings where P. vivax is endemic.

To address this gap, PATH is advancing a portfolio of novel rapid tests for G6PD deficiency that are low cost, simple to use, and meet specifications to improve treatment of patients with P. vivax malaria and support elimination programs. As part of this work, PATH partnered with SD Biosensor to develop and evaluate a new diagnostic for G6PD deficiency.

SD Biosensor's STANDARD G6PD Test is a handheld device that delivers results in two minutes and provides a quantitative measure of G6PD activity, including in heterozygous women. The test uses a small sample of blood, which is placed on a disposable strip and inserted into the reusable device, a format similar to a blood glucose meter that is easy to use at the point of care in low-resource settings. It provides a quantitative measurement of both G6PD levels and total hemoglobin, enabling health workers to determine if radical cure with an 8-aminoquinoline-based drug is appropriate for patients.

"The STANDARD test fills a critical need by improving the ability for health care providers to determine the G6PD status of a patient when it is most needed," says Dr. Gonzalo Domingo, scientific director and malaria diagnostics lead at PATH. "The strength of the partnership resides in SD Biosensor's commitment to making the test available and affordable for malaria-endemic settings."

SD Biosensor has CE marked the STANDARD G6PD Test to conform with the European Union IVD Directive (98/79/EC) and the test is currently undergoing further clinical evaluations. Full clinical evaluation of the test through studies in Brazil, Ethiopia, and India is expected by mid-2019.

PATH will support and guide SD Biosensor in the registration, manufacture, and sale of the new test in countries where P. vivax is endemic and this product will be most impactful. PATH will work with SD Biosensor to provide the STANDARD G6PD Test at favorable pricing terms to priority countries, ensuring that cost will not pose a significant barrier to access where the test is needed most.

Funding to PATH to support advancement of new G6PD diagnostic tools has been provided by UKAid from the United Kingdom department for international development and the bill & melinda gates foundation.

PATH is the leader in global health innovation. An international nonprofit organization, PATH saves lives and improves health, especially among women and children. PATH accelerates innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, PATH takes innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. With these key partners, PATH delivers measurable results that disrupt the cycle of poor health.

SD Biosensor is an in vitro diagnostics company with the goal of contributing to improving the quality of life through fast and accurate diagnosis of disease. Since our foundation, we have provided blood glucose monitors, glycated hemoglobin analyzers, cholesterol analyzers, ELISA kits, and rapid test kits worldwide. As a global diagnostics company, we have set a new benchmark for in vitro diagnostics with our core technologies. At SD Biosensor, we provide diagnostic products of excellent quality by developing fluorescence immunoassay products that can perform qualitative as well as quantitative results using antigen and antibody responses.

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Ugandan Computer Scientist Wins Engineering Prize for Developing Non-Invasive Malaria Test

Languishing with fever and frustrated by delays in diagnosing his illness, Brian Gitta came up with a bright idea: a malaria test that would not need blood samples or specialized laboratory technicians.

That inspiration has won the 25-year-old Ugandan computer scientist a prestigious engineering prize for a non-invasive malaria test kit that he hopes will be widely used across Africa.

For developing the reusable test kit known as Matibabu, Gitta this month was awarded the Africa Prize for Engineering Innovation. The award by the Royal Academy of Engineering in Britain comes with £25,000 ($32,940).

Malaria is the biggest killer in Africa, and the sub-Saharan region accounts for about 80 percent of the world’s malaria cases and deaths. Cases rose to 216 million in 2016, up from 211 million cases in 2015, according to the latest World Malaria Report, released late last year. Malaria deaths fell by 1,000, to 445,000.

The mosquito-borne disease is a challenge to prevent, with increasing resistance reported to both drugs and insecticides.

The new malaria test kit works by shining a red beam of light onto a finger to detect changes in the shape, color and concentration of red blood cells, all of which are affected by malaria. The results are sent within a minute to a computer or mobile phone linked to the device.

A Portugal-based firm has been contracted to produce the components for Matibabu, the Swahili word for “treatment.”

“It’s a perfect example of how engineering can unlock development — in this case by improving health care,” Rebecca Enonchong, Africa Prize for Engineering Innovation judge, said in a statement. “Matibabu is simply a game changer.”

Gitta and five colleagues, all trained in computer science or engineering, developed an affordable, bloodless test that does not need a specialist to operate. The test will be suitable for use in Africa’s rural areas, where most cases of malaria occur, because it will not depend on sending blood samples to a distant laboratory.

Others are also working to fill the need for quicker, easier malaria tests. There are over 200 rapid diagnostic test products for malaria on the market, according to the World Health Organization.

The fifth-generation prototype of Matibabu, with an accuracy rate of 80 percent, is still a work in process. Gitta and his group aim to refine the device until it achieves an accuracy rate exceeding 90 percent.

Matibabu has yet to be formally subjected to all the necessary clinical trials under Ugandan safety and ethics regulations.

“It excites me as a clinician,” said Medard Bitekyerezo, a Ugandan physician who chairs the National Drug Authority. “I think the National Drug Authority will approve it.”

The government should invest in the project so that its developers don’t struggle financially, he added. The unit cost of the latest prototype is about $100.

Despite the optimism, Gitta has found a hurdle he didn’t anticipate: Some patients are skeptical of unfamiliar technology.

“The doctors will tell you that some people will not leave the hospital until their children have been pricked, and until they have been given anti-malaria drugs and painkillers, even if the kid is not sick,” he said.

“We think we are developing for hospitals first, so that people can first get attached to the brand, and gain the trust of patients over time.”

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Real-Time Mycoplasma Contamination Detection for Biomanufacturing

Source referenced below.

Biomanufacturing contamination due to Mycoplasma is a very real concern, as it poses a potential health risk for patients. As such, regulatory agencies require biopharmaceutical companies to test for the presence of mycoplasma both during the manufacturing process and in the final product. While any contamination can be extremely challenging and costly, mycoplasma contamination is particularly difficult.

The presence of mycoplasma in cell culture has been described as pervasive. According to the publication” The scope of mycoplasma contamination within the biopharmaceutical industry, “contamination rates in established cell cultures have been reported between 15 and 35% with considerably higher occurrence cited in certain selected populations.” Its pervasiveness could be due to several different factors, with one certainly being the fact that mycoplasmas can have a broad range of hosts including humans, animals, insects and plants. The small size of mycoplasmas also makes them problematic to detect and remove via filter. Mycoplasmas thrive in cell culture environments because they find nutrients in medium and can grow to high concentrations without initially causing obvious problems to the host cell or culture productivity.

Release Testing Requirements

As discussed, biopharmaceuticals must be completely free of mycoplasmas and regulatory authorities require release testing as part of the manufacturing process. Traditional methods for mycoplasma testing as described in the USP (U.S. Pharmacopeial Convention) and Ph. Eur. (European Pharmacopoeia) involve the culture method and/or indicator cell culture testing. These testing methods, while well defined and widely accepted, are difficult to administer because they require highly trained personnel to administer and can require up to 28 days for results. In addition, difficult to cultivate or non-cultivable mycoplasma species can result in a mycoplasma contamination going undetected. As a result, many regulatory agencies now also accept rapid nucleic acid amplification techniques (NAT) such as real-time quantitative polymerase chain reaction (qPCR) for mycoplasma testing. In addition to final release testing, qPCR testing for mycoplasma enables a more robust in-process control strategy.

qPCR Solution

PCR testing for mycoplasma has been gaining acceptance for some time and Roche CustomBiotech recently presented a poster detailing the validation of their MycoTOOL Mycoplasma Real-Time PCR Kit (MycoTOOL RT) conducted by Roche Pharma (Penzberg, Germany) based on Ph. Eur. 2.6.7 NAT validation guidelines. The United States, European, and Japanese pharmacopeias list nucleic acid tests (NAT) as a mycoplasma testing option provided that they are properly validated.

Click the image to view the entire poster in PDF format.

Poster Highlights

The poster nicely outlines workflow for manual and automated processes and presents data on the validation study results.

MycoTOOL RT Workflow

The MycoTOOL RT is compatible with either manual or automated protocols and testing can be conducted in less than 5 hours for both (Figure 1). This is a significant advantage that PCR has over more traditional methods. Click the workflow image to enlarge. 

Figure 1. MycoTOOL RT work flow using either a manual or automated DNA extraction method. The automated work flow based on the MagNA Pure 96 and LightCycler 480 II systems shown as the red marked process procedure has been fully validated by Roche Pharma Biotech as it is presented in this poster. *Both the MagNA Pure 24 and the QC Preparation Kit are functionally tested, but not validated.

Another advantage for MycoTOOL RT is that it utilizes highly specific TaqMan® probes, which permit the detection of both cultivable and non-cultivable mycoplasma species. This reduces the risk of a contamination going undetected.

Validation Study Results

The study outlined in the poster below, demonstrates compliance of the MycoTOOL RT with the Ph. Eur. 2.6.7 NAT validation guideline, showing that the assay is sensitive, specific, robust, precise and comparable to compendial methods for CHO manufacturing processes.

In the poster, Roche CustomBiotech presents data on limits of detection (LOD), test specificity, test robustness, precision, absence of cross contamination and comparability as part of their validation process. Please refer to the poster for specific details and methods.

A critical part of the data was the results of the comparability study, which concludes that all three of the mycoplasma detection methods: culture method, indicator cell culture method, and MycoTOOL RT were able to detect mycoplasma contaminations with a sensitivity ≤10 CFU/mL. However, MycoTOOL RT was also able to detect strains that are non-cultivable.

Conclusion

It makes sense that biopharmaceutical companies are moving toward a more rapid mycoplasma detection method. With mycoplasma testing that is now quick and efficient, it is a tool that can be more widely used and can serve more purposes. For instance, mycoplasma detection testing could now be used as an inbound quality control step for raw materials or as an in-process early detection approach to avoid further contamination, loss of time and resources.

Image Reference

Mycelia of Mycoplasma contamination growing on a CHO cell. Rottem S, Barile M F. Beware of Mycoplasmas. Trends Biotechnol. 11, 143–151 (1993).

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Bruker Announced Improved Solutions for Microbial Strain Typing, Hospital Hygiene and Infection Control, and Candida auris Testing

At the American Society for Microbiology (ASM) Microbe 2018 meeting, Bruker announced improved solutions for microbial strain typing, hospital hygiene and infection control.

The bench-top IR Biotyper system for microbial strain typing is based on Fourier-Transform Infrared (FTIR) spectroscopy technology, and complements Bruker's world-leading MALDI Biotyper mass spectrometry platform for fast microbial identification from cultures using protein fingerprinting.  The IR Biotyper uses many classes of biomolecules, like lipids, proteins, nucleic acids and polysaccharides simultaneously to characterize a microbial sample by strain-specific absorbance patterns in the infrared spectrum.  This makes the IR Biotyper an efficient tool for fast and cost-effective strain typing.  The IR Biotyper can be used stand-alone for routine hospital hygiene and infection control, or can be combined in a workflow with parallel microbial species identification by the MALDI Biotyper.  Due to its fast time-to-result (TTR), excellent strain differentiation performance, low cost per sample, ease of use, robustness and throughput, the IR Biotyper can perfectly complement next-generation sequencing (NGS) strain typing, which typically requires more time, training and infrastructure in core labs.

The IR Biotyper is easy to use without any prior knowledge of FTIR technology.  Its workflow uses colonies from an agar plate, typically after overnight incubation.  The assay needs only minimal hands-on time supported by the IR Biotyper Kit that allows standardized and straight-forward sample preparation, and contains proprietary test standards for quality control.  Each sample is measured in a few minutes.  The IR Biotyper software offers a simple user interface for the set-up of automated, unattended runs.  The software also includes data interpretation with optimized statistical algorithms and provides clear visualization of the results, for example, as a distance matrix, or as a dendrogram of multiple isolates.  The new IR Biotyper 2.0 software now offers further enhanced bioinformatics capabilities via novel algorithms, connectivity to external expert systems via data export functions, and improved data visualization.

With its easy, user-friendly workflow, fast turn-around time and cost-effective sample preparation, the IR Biotyper enables new in-house workflows in hospital infection control.  More samples can be analyzed prospectively in less time and at a lower cost compared to molecular technologies in hygiene laboratories.  Results are generated directly after the measurements.  This also improves sample logistics as many samples that previously had to be sent to central core molecular testing facilities can now be analyzed directly in the hospital hygiene laboratory.  The IR Biotyper is for research-use-only and not for diagnostic use.  Two scientific posters showing the performance of the IR Biotyper in an outbreak analysis and for the detection of virulence factors in the zoonotic pathogen Arcobacter butzleri will be presented at this ASM Microbe meeting.

Dr. Stefan Zimmermann, Department of Medical Microbiology and Hygiene at the University Hospital Heidelberg, Germany, stated: "We have implemented the IR Biotyper since several months in our laboratory. The IR Biotyper has shown to be a promising tool for rapid and reliable outbreak analysis. In our hands, it showed good concordance with previous typing methods, like pulse-field gel electrophoresis and RAPD-PCR. Its easy handling and short time to result enables routine screening and outbreak prevention. Moreover, the cost-efficient IR Biotyper approach enables research projects in epidemiology with large sample cohorts that previously were not feasible in practice. In addition, we envision further applications like the detection of virulent strains in the future."

Bruker recently received clearance from the U.S. Food and Drug Administration for the identification of C. auris (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm605336.htm) on the MALDI Biotyper CA system.  Candida auris is a yeast species that increasingly causes fungal infections in critically ill hospital patients.  It can cause blood stream infections, urinary tract infections and wound infections. Treatment can be complicated because it can easily be misidentified as other Candida species by traditional methods.  C. auris is frequently multidrug-resistant and has caused several outbreaks in healthcare settings.

C. auris will be added to the MBT CA system's cleared reference library, which now contains 334 species or species groups, covering 425 clinically relevant bacteria and yeast species.  According to the FDA press release, this is "the first test to identify the emerging pathogen Candida auris, which can cause serious infections in hospitalized patients."  The C. auris identification by a FDA-cleared method does not only help individual patients with an important diagnosis, but it enables direct screening and hygiene measures in order to prevent further spreading of the organism.

Dr. Wolfgang Pusch, Executive Vice President for Microbiology & Diagnostics at Bruker Daltonics, commented: "It is a proven strength of the MALDI Biotyper system and identification algorithms that emerging pathogens, such as Candida auris, can easily be added to its reference library.  We are very pleased with this early clearance of the C. auris claim by the FDA in order to make this significant improvement available to the US healthcare system relatively quickly."

About the Bruker MALDI Biotyper (MBT) Platform

The MALDI Biotyper family of systems enables molecular identification of microorganisms like bacteria, yeasts and fungi.  Classification and identification of microorganisms is achieved reliably and quickly using proteomic fingerprinting by high-throughput MALDI-TOF mass spectrometry.  The MALDI Biotyper uses a molecular approach based on specific proteomic fingerprints.  Many published studies have highlighted its greater accuracy and lower cost, as well as typically much faster time-to-result (TTR).

Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product safety and quality control, as well as marine microbiology.  In many laboratories the MALDI Biotyper has replaced classical biochemical testing for bacterial identification due to the accuracy, speed, extensive species coverage, ease of use and cost effectiveness of the system.  Traditional biochemical techniques detect different metabolic properties of microorganisms, can take many hours or even days for completion, and they often lack specificity.

The robust MALDI Biotyper requires minimal sample preparation and offers low consumables cost.  The products of the MALDI Biotyper family are available in a research-use-only (RUO) version, as the U.S. FDA-cleared MALDI Biotyper CA System, or in an IVD-CE version according to EU directive EC/98/79.  The MALDI Biotyper also has medical device registrations in numerous other countries.  RUO versions of the MALDI Biotyper allow selected, high-value antimicrobial resistance tests.

About the Bruker IR Biotyper Platform

The IR Biotyper is a benchtop FTIR spectroscopy system for hospital hygiene and infection control applications.  It used the absorption of infrared light by biomolecules, as infrared light induces vibrations and rotations of covalent bonds in biomolecules. Using this principle, the IR Biotyper simultaneously analyses various classes of biomolecules, such as peptides, proteins, carbohydrates and lipids. The resulting spectrum is a molecular fingerprint of the cellular content. This allows robust differentiation between microbial isolates. After an identification of the microbial species with the MALDI Biotyper, the IR Biotyper allows for rapid, cost-effective typing of strains.

Applications include the analysis of outbreak scenarios in hospital hygiene and epidemiology, as well as root cause analysis in microbial food contamination. The IR Biotyper offers low consumables cost, and requires minimal sample preparation. Starting from an isolated culture on an agar plate, a cell suspension is prepared and an aliquot is deposited on the sample plate and air dried. The measurement itself takes a few minutes. After microbial cultivation, the IR Biotyper allows for quick onsite analysis in the hygiene monitoring laboratory, which compares very favorably with the cost and turn-around time to send samples for molecular testing.  The IR Biotyper is for research-use-only (RUO) in hygiene, infection control and epidemiology.  

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Curetis Launches Unyvero System and LRT Cartridge for Lower Respiratory Tract Infections in the U.S.

Curetis N.V., a developer of next-level molecular diagnostic solutions, announced the U.S. commercial launch of its Unyvero sample-to-answer molecular diagnostic system and the Unyvero LRT Application Cartridge for lower respiratory tract infections at the ASM Microbe 2018 Congress in Atlanta, GA, USA (June 7-11). Curetis obtained regulatory clearance for the Unyvero System and Unyvero LRT from the U.S. FDA in April this year.

The Unyvero System, together with the Unyvero LRT Application Cartridge, provides rapid infectious disease testing directly from aspirate samples in less than five hours. It covers more than 90% of infection cases of hospitalized pneumonia patients and provides clinicians with a comprehensive overview of genetic antibiotic resistance markers detected. As the first-in-class molecular test for lower respiratory tract infections with no direct molecular diagnostic competition, it addresses a significant unmet medical need that causes over $10bn in annual costs for the U.S. healthcare system (see references 1, 2 below). It is also the first time that the U.S. FDA has granted clearance for an automated molecular diagnostic test for the atypical microorganism Legionella pneumoniae.

The potential of the Unyvero System and LRT Application Cartridge to positively impact clinical outcomes, support antibiotic stewardship, and create health economic benefits is substantiated by several key contributions to the scientific program of ASM Microbe 2018:

• Dr. Chiagozie I. Pickens, MD, and colleagues from the Northwestern Memorial Hospital, Chicago, IL, USA show data demonstrating that delays in the transport time of LRT specimens to the microbiology laboratory result in loss of viable pathogens, including virulent nosocomial pathogens. They conclude that "molecular technologies, such as Unyvero PCR, are less affected and identified causative agents even after long transport times."
• Dr. Matthew D. Sims, MD, PhD, and his group at William Beaumont Hospital, Royal Oak, MI, USA, evaluated Unyvero LRT with regard to clinical impact and antibiotic stewardship and conclude that "the Unyvero Platform and the LRT Cartridge have significant potential to improve the management of lower respiratory tract infections and can improve antibiotic stewardship at the same time." This poster is also featured in an oral presentation by Dr. Sims during the Lounge & Learn Session "Outcomes Impacting Income: Cost Effective Clinical Diagnostics."           

In addition, in an Industry and Science Workshop hosted by Curetis USA, Dr. Joseph M. Campos, PhD, D(ABMM), F(AAM), Director of Microbiology Laboratory, Infectious Disease Molecular Diagnostics Laboratory, and Laboratory Informatics at Children's National Medical Center, Washington, DC, USA, will share early results from the evaluation of the Unyvero System and the Unyvero LRT Application at his institution.

"ASM Microbe is an ideal platform to launch the Unyvero System and the LRT Application Cartridge in the U.S.," commented Chris Bernard, President and CEO of Curetis USA Inc. and EVP Global Sales. "The advantages of Unyvero, highlighted by Dr. Pickens and Dr. Sims in the congress' scientific program, are also recognized by many clinicians and laboratory directors at those hospitals we have been actively reaching out to following the FDA clearance decision. We are making very good progress in getting Unyvero Systems installed in several of those accounts short-term and expect to have signed multiple commercial evaluation agreements in the coming weeks. We also received the first commercial Unyvero cartridge order from a U.S. customer."

To drive the commercial roll-out of the Unyvero System and Unyvero LRT as a first application cartridge in the U.S., the Company has completed the U.S. commercial operations setup and has a dedicated team of about 25 seasoned commercialization experts at its Curetis USA Inc. subsidiary in San Diego, CA. With the commercial team in place and the roll-out initiated, Curetis is targeting the placement of 40 to 50 Unyvero Analyzers by year-end 2018 and 60 to 80 Analyzers within the first full year of commercial availability in the U.S.

References

(1)   CDC (2015) 'New CDC study highlights burden of pneumonia hospitalizations among US adults', available at: https://www.cdc.gov/media/releases/2015/p0714-pneumonia-hospitalizations.html

(2)   American Thoracic Society (2015) 'Top 20 pneumonia facts - 2015', available at: https://www.thoracic.org/patients/patient- resources/resources/top-pneumonia-facts.pdf

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Lonza and Innosieve Diagnostics Announce Distribution Agreement for Rapid Solid Phase Cytometry Bioburden Test

Lonza Pharma & Biotech and Innosieve Diagnostics announced today an exclusive distribution agreement for rapid bioburden testing technology. This agreement expands Lonza’s extensive offering of endotoxin products, services and software and provides pharmaceutical testing professionals with a comprehensive set of quality control (QC) tools.

Under the agreement, Lonza will sell and distribute Innosieve Diagnostics’ solid phase cytometry MuScan™ Instrument, Sieve-ID® Total Viable Count Kit and associated software to the pharmaceutical, biotechnology and medical device manufacturing industries.

Control of bioburden during the manufacturing process is a regulatory requirement for the manufacture of drugs and medical devices. Bioburden testing is performed to assure that the bioburden remains low; however, a major challenge with conventional, growth-based bioburden testing is the lengthy time to results.

Innosieve’s MuScan™ Instrument and Sieve-ID® Total Viable Count Kit offer a non-growth-based bioburden testing approach that enables a single sample to be analyzed within one hour from collection; and up to six samples can be analyzed within two hours. The technology employs solid-state cytometry to detect stained microorganisms that are captured on the patented Sieve-ID® filter. Innosieve’s new 21 CFR Part 11-compliant software then determines the number of viable cells present and records the results in an easy-to-read and auditable report.

Dr. Claus-Dietmar Pein, Head of Business Development for Bioscience Solutions at Lonza Pharma & Biotech, said, “By expanding our QC testing portfolio with this rapid, easy-to-use bioburden testing method, we can help increase product safety, speed up processing time, and reduce costs of bioburden detection as end-users will no longer have to wait several days for their results.”

Dr. Michel Klerks, President and CEO of Innosieve Diagnostics, said, “Having received excellent feedback from our current customers, we are now working with Lonza to supply our innovative bioburden-testing technology to the pharmaceutical and biotechnology QC industries.”

Innosieve will continue to offer its full range of products, including the MuScan™ System, to all other markets.

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Micronics PanNAT STEC Test and System Receive FDA Clearance

Micronics, Inc. has announced today that its test for the detection of Shiga toxin-producing E. coli (STEC) has received clearance from the U.S. Food and Drug Administration. The Micronics PanNAT STEC Test is performed in a disposable microfluidics-enabled cartridge and is a qualitative, in vitro nucleic acid amplification-based test that simultaneously detects and differentiates the stx1 and stx2 Shiga toxins and E. coli O157. The cartridge contains all of the reagents required for the test, including a novel approach for integrated positive and negative quality controls.  Sample, reagents, and waste are captured in the cartridge for ease of disposal.

Also cleared by the FDA is the Company's PanNAT System, a compact, fully automated molecular diagnostic device that processes the individual test cartridges. The benchtop-sized instrument is easily portable and designed for use across a diverse range of centralized laboratories.  In the event of short-term power loss, the instrument is battery powered. Additionally, the design of the user friendly interface simplifies the test process.

Users simply insert a patient sample tube into the PanNAT STEC Test cartridge, and then insert it into the instrument to initiate the test. The instrument provides a sample-in to result-out answer in approximately one hour, with no sample preparation required.

The PanNAT STEC Test is Micronics' first molecular diagnostic test to receive FDA clearance required for U.S. sales and distribution.  CE Marking of the system and test also are planned for Europe.

"The ease of use of the PanNAT System and STEC Test provide a needed solution for rapid testing," said Karen Hedine, Micronics' President. "Micronics believes that the PanNAT System is poised to take advantage of the expanding use of low to medium multiplex assays for timely diagnosis across a diverse group of customers, while also being responsive to the reimbursement environment."

Micronics, Inc. is a wholly-owned subsidiary of Sony Corporation of America. The company is based in Redmond, Washington and holds an early and broad patent estate in microfluidics.

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T2 Biosystems Receives the First FDA Clearance for the Detection of Sepsis-Causing Pathogens from Whole Blood

T2 Biosystems, Inc., an emerging leader in the development and commercialization of innovative diagnostic products for critical unmet needs in healthcare, announced that it has received market clearance from the U.S. Food and Drug Administration (FDA) for the T2Bacteria® Panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections. The T2Bacteria Panel, for the first time, provides sensitive detection of specific sepsis-causing bacterial pathogens directly from a whole blood specimen in approximately 5 hours. This was more than 2.5 days faster than blood culture-dependent tests as demonstrated in the over 1,400 patient pivotal trial conducted at 11 hospitals in the United States. All other FDA-cleared diagnostic tests that detect bacteria in blood require a positive blood culture sample prior to bacterial species specific identification, which typically delays results by one to five days. For patients at risk of sepsis, rapid targeted treatment based on the identification of causative pathogens is critical because it is estimated that every hour of speeding up the time to targeted therapy decreases patient mortality by nearly 8%.  

“The T2Bacteria Panel’s rapid results and high sensitivity make it a valuable tool for the diagnosis and management of suspected bloodstream infections,” said W. Frank Peacock, MD, FACEP, FACC, professor, associate chair, Baylor College of Medicine. “This is an important breakthrough as bacterial infections are a major cause of poor patient outcomes and high hospital costs. This is a game-changer.”

In addition to the more than tenfold improvement in time to result demonstrated in the pivotal clinical trial, the T2Bacteria Panel also achieved an overall average sensitivity of 90% and an overall average specificity of 98%, while demonstrating no interference from the presence of antibiotics in the bloodstream.

“The results from the T2Bacteria pivotal clinical trial were impressive, demonstrating excellent performance and advantages over blood culture,” said Minh-Hong Nguyen, MD, director, Antimicrobial Management Program and director, Transplant Infectious Diseases, UPMC. “T2Bacteria’s detection of bloodstream infections and fast species identification at high sensitivity will expedite life-saving interventions such as the targeting of therapy within hours of blood draw.”

The T2Bacteria Panel, like the previously FDA-cleared T2Candida® Panel, runs on the Company’s proprietary, FDA-cleared T2Dx® Instrument. The FDA-cleared T2Bacteria Panel identifies five of the most common and deadly sepsis-causing species of bacteria: Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus aureus.  

Bacterial and fungal bloodstream infections are a leading cause of sepsis, a life-threatening illness that affects 1.6 million U.S. patients each year, resulting in over 250,000 deaths or almost 50% of all deaths of U.S. hospitalized patients. Studies have shown that the mortality rate for bloodstream infections can be reduced significantly with appropriate targeted therapy within 12 hours.

“The FDA’s market clearance of the T2Bacteria Panel is a significant milestone for our company, but more importantly, for millions of patients at risk of sepsis from bloodstream infections,” said John McDonough, president and chief executive officer of T2 Biosystems. “This breakthrough technology provides potentially life-saving answers for patients and economic savings to hospitals that bear the enormous burden of sepsis-related care and mortality.”

About Bloodstream Infections 

Treating bloodstream infections earlier may prevent progression to sepsis, one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs exceeding $27 billion. Sepsis claims more lives annually than breast cancer, prostate cancer, and AIDS combined and is the most prevalent and costly cause of hospital readmissions. The pathogens that cause sepsis infections are difficult to detect and can be deadly even at very small concentrations in the bloodstream. With sepsis, one hour of delayed treatment increases mortality risk by nearly 8%. The T2Bacteria Panel uses magnetic resonance technology to help detect the presence of five clinically relevant species of bacteria directly from a patient's blood sample in approximately five hours, versus one to five days or more with current diagnostic methods, potentially enabling more rapid treatment that may prevent the progression of a bloodstream infection to sepsis.

About T2 Biosystems 

T2 Biosystems, an emerging leader in the development and commercialization of innovative medical diagnostic products for critical unmet needs in healthcare, improves patient care and reduces the cost of care by helping clinicians effectively treat patients faster than ever before. T2 Biosystems’ products include the T2Dx Instrument, T2Candida Panel and T2Bacteria Panel and are powered by the proprietary T2 Magnetic Resonance (T2MR®) technology. T2 Biosystems has an active pipeline of future products, including detection of additional species and antibiotic resistance markers of sepsis pathogens and tests for Lyme disease.

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CDC Unveils New Rapid Rabies Detection Test

The Centers for Disease Control and Prevention (CDC) announced that its researchers have developed a test that can more easily and precisely diagnose rabies infections. The new test—designed for use in animals—is being celebrated for its ability to deliver accurate results in as little as 2 hours, allowing doctors to make more informed decisions about who might need treatment.

The CDC’s announcement of the LN34 test was accompanied by pilot study results recently published in PLOS One. This was the largest study ever to validate usage of a real-time polymerase chain reaction (PCR) test to diagnose rabies in animals.

During the study, approximately 3000 brain samples from 60 mammal species—including dogs, raccoons, skunks, foxes, and bats—from areas in the Americas, Europe, Africa, and Asia were assessed. Of the samples, 1000 were known to be infected with rabies virus.

The LN34 test correctly identified all direct fluorescent antibody (DFA)-positive samples as positive. Additionally, the LN34 assay produced definitive findings for 80 samples that the DFA test had determined were inconclusive or untestable, 29 of which were positive for rabies. Of the 3000 samples tested, the LN34 test identified 1 false-negative and 11 false-positive DFA test results. Only 1 sample was indeterminate using both tests.

Together, the authors said, the results demonstrate the “reliability and robustness of the LN34 assay” and support a role for the test in improving rabies diagnostics and surveillance.

To date, the DFA test has been regarded as the gold standard for post-mortem rabies diagnostics and the only internationally-approved test. However, according to the CDC, the DFA, “can only be interpreted by laboratory workers with special skills, extensive training, and a specific type of microscope.” The test can also only be run on fresh brain tissue samples that have been kept cold. As such, it is difficult to use and access in resource-poor areas.

By contrast, researchers found that the LN34 test “was able to detect minuscule amounts of rabies virus genetic material, even in samples so old they had liquefied. Moreover, the condition of the sample did not affect the test’s accuracy.”

The CDC said it is working with the Association of Public Health Laboratories to develop a rabies testing guidance that will help clinicians and laboratory staff decide which tests to run in different scenarios and which tests can be used to confirm rabies, either singly or in combination.

Additionally, the World Health Organization and the World Organization for Animal Health are now considering adding PCR-based tests for primary diagnosis. A favorable ruling would mean the LN34 test could be used in place of the DFA test.

“The LN34 test has the potential to really change the playing field," Crystal Gigante, PhD, a CDC microbiologist and 1 of the study authors, said. “Quickly knowing who needs to receive rabies treatment, and who does not, will save lives and families' livelihoods."

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Purdue Develops Smartphone System That Rapidly Detects Foodborne Pathogens

Purdue University researchers have developed detection technology that allows a typical smartphone to analyze produce for foodborne pathogens such as E. coli O157:H7, which has been linked to a deadly outbreak in romaine lettuce.

The technology involves both hardware – a smartphone cradle – and software in the form of an application that is downloaded on the phone. The combination allows the smartphone to be used as an on-site luminometer, an instrument used to measure light.

The lettuce or other produce is rinsed with an enrichment liquid containing a modified phage, a virus for bacteria. The phage then infects harmful foodborne bacteria so that when a substrate is added, they emit light, which is detected by the smartphone’s camera through the downloaded app and a green dot appears on the screen.

The cradle on the phone maximizes the photon collection by using diffusive reflection material to help capture a maximum amount of light, which may not be visible by the naked eye.

“This technology could be used on a farm or in a food processing factory to provide on-the-spot detection,” said Euiwon Bae, a senior research scientist in the Purdue School of Mechanical Engineering, who developed the technology along with Bruce Applegate, a professor in the Purdue Department of Food Science. “This rapid detection is critical for getting safe produce to consumers.”

The smartphone technology, coupled with the phage, helps reduce the typical amount of time it takes to test food samples for possible foodborne illnesses. The current process involves gathering a physical sample and then shipping it to a lab and waiting several days for the results.

The Food and Drug Administration estimates there are about 48 million cases of foodborne illness annually in the U.S. — the equivalent of sickening one in six Americans each year. These illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths annually. Foodborne illnesses have been in the spotlight recently because of the deadly E. coli O157:H7 outbreak tied to romaine lettuce.

The special phage used with the smartphone technology was developed by Applegate and is being commercialized by Phicrobe, a Purdue University-affiliated startup founded by Applegate. The phage technology can be used to detect not only E. coli O157:H7, a harmful and potentially deadly strain, but also other foodborne pathogens that cause Listeria and Salmonella infection outbreaks. The phage technology also has applications for detecting contaminants in water.

“It’s sort of like reprogramming a computer,” Applegate said. “We take the technology and manipulate it to detect various harmful pathogens that are present.”

The U.S. Department of Agriculture provided some funding for the technology research, and part of the research was conducted by the Purdue Center for Food Safety Engineering. A patent application has been filed by the Purdue Office of Technology Commercialization, and the technology is available for licensing.

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LexaGene’s Prototype for Better Pathogen Detection Now Capable of Identifying E. coli and Staph

With the recent outbreaks associated with romaine lettuce (E. coli) and eggs (Salmonella) in the headlines, LexaGene Holdings Inc., a biotechnology company that develops instrumentation for pathogen detection, announced today that its prototype for more effective pathogen detection is now generating data, including the ability to identify E. coli and Staph. The technology was designed for healthcare providers and food safety officers to use at their facilities for pathogen detection and will be able to process six samples at a time – searching for over 22 pathogens – and return results in about one hour.

“Generating data with the prototype is a monumental milestone for the Company, especially given that we are at such a critical moment in society right now with new foodborne illnesses happening so frequently,” said Dr. Jack Regan, LexaGene’s CEO. “We look forward to demonstrating the prototype firsthand so that people can appreciate the impact this technology will have on the food industry. Over the next several months, we will continue to optimize the performance of the instrument and equip it with reagents to detect more diseases such as Salmonella and Listeria. Once we finalize our pathogen-detection panel, we’ll begin processing samples to demonstrate our advantages over standard testing procedures.”

Not only does LexaGene aim to provide better technology to reduce the chances of shipping contaminated food items, but it anticipates applying this same technology to help doctors diagnose sick patients. Traditionally, healthcare providers collect a sample from a patient and ship it to an offsite laboratory for testing, which takes between two and five days to return a result. In the meantime, the provider often prescribes a treatment without knowing the true cause of the infection, or whether it is resistant to a therapeutic. By contrast, LexaGene’s technology will identify the presence of antibiotic-resistance bacteria, which will empower healthcare providers to treat their patients with more targeted therapies while they are still in the facility.

“The current system for detecting dangerous pathogens is clearly broken,” added Dr. Regan. “We need an easier and less expensive solution to find deadly bacteria like E. coli and Salmonella, whether it is in the food plant or a sick person. LexaGene’s technology will soon be the world’s first easy-to-use, open-access, on-site rapid pathogen detection system that has the potential to change how we prevent and diagnose disease.”

About LexaGene Holdings Inc.

LexaGene is a biotechnology company developing the very first easy-to-use fully automated pathogen detection platform that is open-access, the LX6. The open-access feature will empower end-users to target any pathogen of interest, as they can load their own real-time PCR assays onto the instrument for customized pathogen detection.  End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, and press ‘go’. The instrument is expected to offer excellent sensitivity, specificity, and breadth of pathogen detection. The instrument will be able to process six samples at a time, in an on-demand fashion, returning results in about 1 hour. The company expects to sell its technology in the food safety, veterinary diagnostics, water quality monitoring, and aquaculture pathogen surveillance markets.

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FDA Clears Expanded Claims for Cepheid Superbug Test

Cepheid announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria. The additional claims extend use to analysis of perirectal swab specimens and allow use of Xpert Carba-R test results to guide therapeutic strategies for pure colonies.

"Controlling the spread of carbapenemase-producing organisms in healthcare settings requires rapid recognition, coordinated surveillance, effective infection prevention activities, and a strong commitment to antimicrobial stewardship," said Dr. Fred C. Tenover, Cepheid's Vice President for Scientific Affairs and former Director of CDC's Office of Antimicrobial Resistance. "The addition of perirectal swab specimens to the product label should facilitate active surveillance testing programs, while the ability to use Xpert Carba-R results for therapeutic strategies should enhance antimicrobial stewardship efforts, especially in hospitals struggling with the spread of multidrug-resistant organisms."

Carbapenemase-producing CRE are currently believed to be primarily responsible for the increasing spread of CRE in the United States and have been targeted by the CDC for aggressive prevention measures (see http://www.cdc.gov/hai/organisms/cre/definition.html). Detection and differentiation of high-risk patients with Xpert Carba-R can alert clinicians and infection preventionists quickly to the presence of gene sequences associated with carbapenem non-susceptibility in gram-negative bacteria, including Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter baumannii. Rapid detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies helps clinicians optimize patient management and direct therapeutic strategy. Perirectal and rectal swabs are not intended to direct therapeutic strategy.

About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated molecular testing in virtually any setting. Through a strong foundation in innovation, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.

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MicrobeDx Wins CARB-X Funding Award to Advance Its System for Rapid Detection of Antibiotic Resistant Bacteria

MicrobeDx, Inc., a biotechnology company addressing the global crisis in antibiotic resistance, today announced that it had entered into a collaboration with CARB-X (Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), a global public-private partnership focused on funding the development of promising new antibiotics and rapid diagnostics.  The partnership will advance the development MicrobeDx's breakthrough diagnostic system, which utilizes a compact desktop device to detect the presence of bacteria in clinical urine specimens within 30 minutes and complete anti-microbial susceptibility testing within three hours, versus 48-72 hours under the current standard of care.  While initially focused on urinary tract infections, MicrobeDx's system may ultimately be utilized on a variety of bodily fluids, including positive blood cultures.

"MicrobeDx's technology addresses a critical unmet need: rapid, accurate and cost-effective near-to-care testing that enables correct antibiotic therapy from the patient's first dose," said Dr. Bernard Churchill, Chairman and CEO of MicrobeDx.  "We are both pleased and honored to be partnering with CARB-X to accelerate the development of our products and allow doctors to use them, and patients to benefit from them, sooner."

"MicrobeDx aims to speed the diagnosis and treatment of UTIs, taking the guesswork out of treatment decisions in the first critical hours of illness," said Kevin Outterson, Executive Director of CARB-X. "The world urgently needs new diagnostics and other products to protect us from life-threatening drug-resistant bacteria.  The projects in the Powered by CARB-X portfolio are in the early stages of development, but if successful, they offer great potential in the fight against drug-resistant bacteria and in saving lives."

MicrobeDx's technology utilizes a transformational ribosomal RNA-based assay on an innovative microfluidic disc platform developed at UC Irvine that is both compact and cost-effective. By rapidly identifying whether bacteria are present and, if so, which antibiotics they are susceptible to, MicrobeDx's system aims to reduce the number of unnecessary and ineffective prescriptions and facilitate the prompt and effective treatment of infections.  The Company's unique method has the potential to dramatically improve patient outcomes, reduce healthcare costs and preserve the miracle of safe and effective antibiotics for future generations.

About MicrobeDx

MicrobeDx is an early-stage biotechnology company focused on addressing the global crisis in antibiotic resistance through real-time personalized antibiotic selection.  Based on over 15 years of innovative research at UCLA and UC Irvine, MicrobeDx is harnessing the power of its ribosomal RNA-based technology on an innovative centrifugal disc microfluidic platform.  Funded by benefactor donations, NIH/NIBIB and NIH/NIAID grants, private capital and now CARB-X, the MicrobeDx diagnostic system is currently in product development, to be followed by manufacturing and FDA clinical studies, with market launch expected in 2020.

About CARB-X

CARB-X is the world's largest public-private partnership devoted solely to accelerating early development antibacterial R&D. Funded by ASPR/BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X is investing up to $455 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, rapid diagnostics and devices to treat drug-resistant bacterial infections. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X operates through Boston University. Other partners include RTI International, the Broad Institute of Harvard and MIT, MassBio, and the California Life Sciences Institute (CLSI).

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Genetic Signatures Receives TGA Approval to Market Superbug Detection Kits in Australia

Molecular diagnostics company Genetic Signatures has received Therapeutic Goods Administration (TGA) registration, thereby allowing the sale of its novel “Extended Spectrum Beta-Lactamase and Carbapenemase Producing Organisms” (ESBL & CPO) detection kit in Australia.

This follows the company’s receipt of European approval last month which enabled the sale of the ESBL & CPO products across Europe.

The company’s tongue-twistingly-named product detects hospital ‘superbugs’ and ‘antibiotic-resistant’ pathogens in under 3 hours.

Today’s news means Genetic Signatures can now sell its EasyScreen ESBL & CPO detection kits across Australia in addition to its existing set of TGA-registered products based on its EasyScreen platform, underpinned by “3base multiplex technology”.

Genetic Signatures says that at the current time, its key target markets are major hospital and pathology laboratories undertaking infectious disease screening, although this could potentially change dependent upon market demand and the future prevalence of antibiotic-resistant superbugs.

Superbugs have quickly become a significant global concern for healthcare professionals around the world. “Superbug” is a term that’s been coined to describe strains of bacteria that are resistant to commonly-used antibiotics.

Resistant bacteria that cause pneumonia, urinary tract infections and skin infections are just a few of the effects of such so-called superbugs that have become a worrying problem for hospitals.

Fighting superbugs starts with detection

Genetic Signatures designs and manufactures a suite of real-time Polymerase Chain Reaction (PCR) based products for the routine detection of infectious diseases under its proprietary EasyScreen brand.

Its MDx 3base technology provides high-volume hospital and pathology laboratories with the ability to screen for a wide array of infectious pathogens, with a high degree of specificity and greatly improved time horizon.

According to a study by the Rand Corporation in 2014, the estimated global cost of antimicrobial resistance is approximately US$95 billion per year (and growing) over the next 20 years.

Given standard treatments may be rendered ineffective against superbugs, rapid identification of infected patients is important, so they can be isolated and treated before the infection spreads.

The company said its EasyScreen ESBL & CPO Kit allows for rapid detection in less than 3 hours with “minimal hands-on time” for laboratory technicians.

The detection kit has been designed to provide rapid and accurate detection of 16 Beta-lactam and Carbapenem-resistant pathogen targets and is therefore able to identify a larger number of pathogen targets in a shorter time frame than conventional methods.

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