Meridian’s Rapid and Easy Test for M. Pneumoniae Now Available in the US

Meridian Bioscience announced that the U.S. Food and Drug Administration (FDA) has cleared its newly updated and simplified molecular diagnostic test for Mycoplasma pneumoniae, the cause of an infectious if mild form of pneumonia often called “walking pneumonia.”

The Illumigene Mycoplasma Direct assay was launched in Europe earlier this year, having received the CE Mark from the European Union. It is an improved version of a test cleared by the FDA in 2013. The assay consists of a simplified and easy three-step procedure that eliminates the need for specialized training, and provides definitive results in less than one hour.

The test utilizes throat swabs and requires less than two minutes of hands-on time to process. Its ability to accurately detect infection soon after symptoms appear also makes it less likely that broad spectrum antibiotics would be prescribed to people, limiting their likelihood of developing antimicrobial resistance.

“As the market share leader for Mycoplasma pneumoniae testing, we are pleased to be able to offer our customers an improved molecular assay for Mycoplasma pneumoniae. By simplifying the procedure of illumigene Mycoplasma we are able to address a larger customer base with a superior diagnostic tool that will dramatically improve patient care,”  Mike Shaughnessy, executive vice president and president of Meridian Global Diagnostics, said in a news release. “Traditional methods of diagnosis include serology and X-Ray which may have as low as 25% and 41% sensitivity respectively, making rapid, targeted detection for specific treatment difficult. Our illumigene molecular platform does not require cumbersome capital equipment or costly hidden service contracts. We believe illumigene is the best value choice for molecular detection in infectious disease.”

The illumigene Mycoplasma Direct is now available for order in the U.S., as are other assays in the company’s portfolio, including tests for C. difficile, Group A Streptococcus, Group B Streptococcus, Herpes Simplex Virus type 1 & 2, pertussis, chlamydia, gonorrhea, and malaria.

According to the Centers for Disease Control and Prevention, between 1 and 10 out of every 50 cases of community-acquired pneumonia in the United States are caused by M. pneumoniae. The mild illness is especially common in children and young adults.

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Alere q HIV-1/2 Detect Point-of-Care Molecular HIV Assay Receives WHO Prequalification

Alere Inc., a global leader in rapid diagnostics, today announced that its Alere™ q HIV-1/2 Detect assay has been awarded World Health Organization (WHO) prequalification, making it available for public sector procurement. The Alere q HIV-1/2 Detect is the first-ever molecular diagnostic that identifies HIV-1 and HIV-2 at the point of care (POC) in less than 60 minutes, and the first testing application on the Alere q platform.

The Alere q is a portable molecular diagnostic platform designed for use at the point of care.  The WHO prequalification is for the Alere q instrument and its first application, the Alere q HIV-1/2 Detect cartridge. The Alere q HIV-1/2 Detect assay has the ability to detect and differentiate between HIV-1 and HIV-2 using just 25 μl of whole blood or plasma. An immediate and urgent application for this test is Early Infant Diagnosis (EID). Diagnosing HIV in infants via molecular, as opposed to antibody testing, is critical because babies born to HIV-positive mothers have the mother's protective antibodies in their blood, and current POC antibody tests are not able to discriminate between a mother's and an infant's antibodies to detect if a newborn is infected with HIV. With WHO prequalification, the Alere q HIV-1/2 Detect can be actively deployed by global health organizations in developing countries. The test will be used by health workers to identify infants born with HIV infection, and link them to antiretroviral therapy (ART).

"Children with HIV are significantly – and tragically – less likely to receive ART compared to adults1, and traditional methods of EID do not address this gap because they don't allow for immediate linkage to care," said Avi Pelossof, Alere Global President of Infectious Disease. "Now, countries with the highest burden of HIV infection will have broader access to the Alere q HIV-1/2 Detect, which delivers lab-accurate results in 52 minutes. This will empower health workers to diagnose HIV while the mother and newborn are present, and immediately initiate ART if needed – giving these children a fighting chance to survive and thrive."

"Currently, most newborns in developing countries are screened for HIV infection via dry blood spot testing, but because health workers have to wait 3 to 6 weeks for results many potentially HIV-positive infants are lost to follow-up and remain untreated," said Landon Myer, M.D., Ph.D., Associate Professor, School of Public Health and Family Medicine, University of Cape Town. "Now that point-of-care molecular EID can be implemented as part of national guidelines, health workers have a powerful tool to help meet WHO goals for timely viral HIV screening of newborns."

About the Alere q HIV-1/2 Detect Assay

Alere q uses a multiplexed real-time polymerase chain reaction (PCR) methodology that allows amplification and detection of more than one target at the same time. In the case of the Alere q HIV-1/2 Detect, the assay can identify and distinguish between HIV-1 subgroup (M/N), HIV-1 subgroup (O) and HIV-2 and incorporates a series of onboard controls with every sample run in 52 minutes. This ensures the broadest coverage of subgroups and recombinant circulating forms of any commercially available molecular diagnostic assay. The Alere q was designed and engineered to operate in diverse and challenging environments and can be battery-powered. The clinical evidence for Alere q HIV-1/2 Detect assay in EID was demonstrated in a 2014 study published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). Results showed that five clinics in Mozambique used the assay, with high sensitivity and specificity, to diagnose HIV in infants, expediting the initiation of ART.2

Prior to WHO prequalification, the Alere q instrument was IVD CE marked (self-certified) on August 1, 2014 and the Alere q HIV-1/2 Detect assay received IVD CE certification on February 12, 2015.

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Rapid Test for Group B Strep at Labour Piloted

Implementing a rapid test for group B streptococcus (GBS) in pregnant women at the onset of labour could help better target those who need antibiotic prophylaxis, a pilot study at the Rotunda Hospital has shown.

The research, carried out by Consultant Obstetrician and Gynaecologist Dr Meave Eogan, found that among a cohort of 200 women 15-20 per cent carried GBS.

The study revealed that a proportion of women with risk factors for GBS were receiving antibiotics in labour but were not carriers at that time. There were also women not receiving antibiotics in labour who were carriers. During the course of the study, which was presented at the recent Rotunda Hospital Research Day, no babies became significantly unwell due to GBS.

“There were a number of babies who were receiving septic screens after they were delivered whose mother’s didn’t have group B strep. So the babies were being intensively monitored after birth when they weren’t really at risk,” Dr Eogan said.

The PCR test used was the GeneXpert GBS test manufactured by Cepheid. It claims to produce positive results in 32 minutes with negative results in under an hour. It boosts sensitivity of 91.9 per cent and specificity of 95.6 per cent. Dr Eogan said they compared the test to gold standard lab cultures and found it to be accurate.

The next step was to expand the study and explore the cost-effectiveness of the approach, she said. While it costs about €40 per person, the PCR test could potentially reduce antibiotic use and interventions in newborns. In countries where universal screening was offered between 35 and 37 weeks gestation, the rapid test has been deemed cost-effective, she added.

While universal screening is recommended in the US, Australia and many European countries, Ireland and the UK have taken a risk-based approach to date. Having a previous baby affected by GBS, preterm labour, waters being broken for more than 18 hours and a high temperature during labour are among the risk factors for infection.

Dr Eogan said that while there had long been discussion about introducing universal screening in Ireland, it was introduced in the US because it traditionally had a higher incidence of GBS. “The US has brought down its incidence of invasive group B strep disease to 0.4 per 1,000, which is really in or around our steady state,” she said.

Dr Eogan added that the problem with screening at 35-37 weeks gestation was that carriage of GBS could be dynamic. Women can be falsely reassured by a negative screen at 35 weeks, but be carriers at the onset of labour. On the other hand, women who screen positive at 35 weeks can be “terribly nervous for the last five weeks” but not carry it at the time of labour.

“We can now use PCR, which means we can screen women at the onset of labour and make real-time decisions for them, and this will better enable us to triage people for antibiotics in labour. It probably won’t change the number of people who get antibiotics but… you would hope it would make sure that the people who get antibiotics are the people who really need them,” she said.

Figures from the Rotunda over the past 13 years showed that less than 1-in-1,000 babies became significantly unwell as a result of GBS.

Dr Eogan said it affected between 30 and 60 babies in Ireland a year among approximately 65,000 births.

However, the literature showed that of those who became significantly unwell, the mortality rate was as high as 10 per cent.

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MRSA Detection Technology Developed by TGen-NAU is Granted First Patent

Antibiotic-resistant infections should be easier to detect, and hospitals could become safer, thanks to a technology developed by the Translational Genomics Research Institute (TGen) and Northern Arizona University (NAU), and protected under a patent issued by Australia.

Soon, similar patent approvals are expected by the U.S., Canada, European Union, Japan, Brazil and other nations for this "superbug" test developed by TGen and NAU, and licensed to DxNA LLC, a company based in St. George, Utah.

"This rapid, 1-hour test will precisely identify a family of antibiotic-resistant Staph infections we broadly refer to as MRSA," said Dr. Paul Keim, Director of TGen's Pathogen Genomics Division, or TGen North, based in Flagstaff.

"We hope this technology will be adopted worldwide by hospitals and clinics, and will help identify and isolate these dangerous and difficult-to-eliminate infections that have come to plague our medical institutions," said Dr. Keim, who also is the Cowden Endowed Chair of Microbiology at NAU, and Director of NAU's Center for Microbial Genetics and Genomics (MGGen). "The result should be more rapid diagnosis, improved treatment of patients, and reduced medical costs."

MRSA -- Methicillin-resistant Staphylococcus aureus -- is an antibiotic-resistant form of the Staph bacteria that annually kills more Americans than HIV.

While MRSA technically refers to one particular strain of Staph, the genomics-based test developed by TGen, NAU and DxNA can precisely detect multiple types of drug-resistant Staph bacterial infections, including drug resistant Coagulase Negative Staphylococcus (CNS), a much more common infection than MRSA.

Staph infections are the most common hospital-acquired or associated infections. While most of the focus over the past few years has been on MRSA, in terms of incidence and total cost, strains of Staph other than MRSA are a much more common problem.

Due to the increasing use of implantable biomaterials and medical devices, infections are increasingly caused by CNS. This is a type of Staph that is often resistant to multiple antibiotics and has a particular affinity for these devices.

"Rapid identification and differentiation of these resistant bacteria is key to optimizing treatment decisions that significantly impact patient outcomes and cost of care," said David Taus, CEO of DxNA LLC. "Given that resistant CNS is a frequent pathogen in surgical site infections, orthopedic and cardiac device infections, and blood stream infections -- among others -- it is critical that we be able to rapidly identify and determine antibiotic resistance to provide for appropriate pre-surgical antibiotic prophylaxis to prevent infections and early and effective treatment when these infections do occur."

Current molecular tests for MRSA all ignore CNS, rendering their results significantly less useful in treating patients given that drug resistant CNS infections are many times more common than MRSA.

DxNA's Staphylococcus Test identifies and differentiates resistant and non-resistant strains of Staph and CNS. The test uses three separate proprietary biomarker targets and a proprietary methodology to determine which types of Staph are present, and which carry the gene that causes antibiotic-resistance in these bacteria.

"The test also is effective in identifying infected specimens where there are multiple types of Staph. The test will rapidly provide broader clinically-actionable results, improving antibiotic prophylaxis, early targeted intervention resulting in more effective treatment at lower costs," Taus said.

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Nanoparticles May be Used for Accurate and Cheaper Malaria Diagnosis

Nanoparticles may be the key to cheaper and more accurate ways of diagnosing malaria.

Chun Huh, a University of Texas at Austin petroleum engineering research professor, and his team are developing rapid diagnostic test kits that could play a role in distinguishing between a malaria-free person and a contaminated person.

“Currently, the big problem is you can dispense the malaria prevention drugs to people but cannot distribute them indiscriminately,” Huh said. “It’s too expensive and there could be some side effects. But it is vital to detect if the person has malaria parasite in their body or not.”

Huh said the kit he is developing can take saliva samples from a wide range of people and then test who has malaria using a magnetic generator. He said these kits will make administering prevention drugs cheaper and more accurate.

Huh worked with Ijung Kim, a postdoctoral student who focused on using nanoparticles for oil, and Kim’s wife, Yeonjeong Ha, whose doctoral research focused on using nanoparticles to catch biomaterial. Kim previously worked with Huh in using particles for data collection, chemical delivery and water management in oil production.

Ha said the idea for this research stemmed from her curiosity about repurposing the particles for medical needs after seeing many different applications in other industries.

Nanoparticles have a greater surface area per weight than larger particles and are more reactive, both of which make them a versatile tool. Particles are currently being developed for use in medical applications, manufacturing, oil production and electronics.

“Current techniques rely on getting the patient’s blood sample, but it is a problem because most of the people [affected] live in unclean environments,” Huh said.

Instead of drawing blood, the trio will gather samples from a patient’s saliva. Huh, Kim and Ha will utilize three unique functionalities of nanoparticles to create their diagnostic test kit: magnetic pulling, heating and remotely sensing.

Nanoparticles coated with the malaria antibody are first added to saliva samples. Antibodies are cells that target a specified disease and enable the nanoparticles to identify and attach themselves to the malaria antigen when they encounter them. The team will then incubate these samples, using a technique called hyperthermia.

In this process heat is added to the malaria antigen, causing it to grow. The antigen within the saliva can then be detected with a magnet. Finally, a generator is used to create an induction magnetic field that detects the presence of malaria. The researchers then use a magnet to pull the antigens out of the saliva.

If malaria is not detected, the nanoparticles do not attach themselves to anything and are pulled from the saliva sample with the magnet.

“Right now, we are trying to generate the nanoparticles,” Huh said. “Hopefully, in three to six months we can demonstrate the nanoparticle attaching to the malaria antibody.”

Huh said the next milestone would be to pull the nanoparticle and malaria antibody together and then burn off the malaria in the sample.

Even though they are still in the beginning stage of their research, Ha and Kim have many ideas about future possibilities. Specifically, the team recognizes the potential of magnetic components of nanoparticles and hopes to apply this technique to different types of diseases.

“We are expecting to develop these magnetic nanoparticles coupled with the diagnostic kit as a platform for detection of others types of diseases, like Zika,” Kim said. “When you have a new type of disease in the future...you might be able to [use] this kit for detecting the new disease.”

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SRC's Aklus Shield Selected for S. Korean Airborne Biodefense Program

SRC has been selected to work on the initial deployment of the Aklus Shield J-Model biological defense system in South Korea, the company announced Thursday.

The system is part of the Joint United States Forces Korea Patrol and Integrated Threat Recognition (JUPITR) program, SRC said.

JUPITR, a U.S. Army program, will provide unique biological detection capabilities that will decrease soldier workload, lower operational costs, increase performance and fortify South Korea's biodefense capabilities.

SRC was one of the contractors selected following recent government live agent testing of off-the-shelf aerosol biological sensors, the company said.

The Aklus system underwent first-phase testing at the Aberdeen Proving Ground in Maryland and the Key West Naval Air Station in Florida.

The Aklus line features, automated, lightweight, battery-operated, networked warning systems that can be configured for full chemical, biological, radiological and nuclear detection via vapor and aerosol sensing.

SRC has also been working on a lighter, smaller and more affordable biological threat detection system.

Known as the "C-Model," the system will be commercially available to customers needing such capabilities in places like industrial facilities, airports, malls, stadiums and other highly populated areas.

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Rapid Retrieval of Live, Infectious Pathogens from Clinical Samples

Pinpointing the type of bacteria that are at the root of an infection in clinical samples removed from living tissues, such as blood, urine or joint fluids, to quickly identify the best anti-microbial therapy still poses a formidable challenge. The standard method of culturing can take days to reveal pathogens, and they often fail to bring them to light altogether.

A team lead by Donald Ingber, M.D., Ph.D., at the Wyss Institute for Biologically Inspired Engineering at Harvard University now reports a method in PLoS, which enables the rapid isolation and concentration of infectious bacteria from complex clinical samples to help speed up bacterial identification, and it should be able to accelerate the determination of antibiotic susceptibilities as well.

"We leveraged FcMBL — the genetically engineered pathogen-binding protein we developed for our sepsis therapeutic device program — to develop a fast and simple technology to help overcome this diagnostic roadblock,” said Ingber, who is the Wyss Institute’s Founding Director, the Judah Folkman Professor of Vascular Biology at Harvard Medical School and the Vascular Biology Program at Boston Children’s Hospital, and Professor of Bioengineering at the Harvard John A. Paulson School of Engineering and Applied Sciences. “Using clinical samples of joint fluids, we were able to show that this method can be used to quickly and efficiently isolate bacterial pathogens for various kinds of subsequent analysis, including PCR, which is commonly used for molecular diagnostics in clinical laboratories.”

FcMBL is a recombinant form of the human blood protein, Mannose Binding Lectin (MBL), fused to a portion of the antibody Fc domain. The engineered protein can bind to more than 90 different microbial pathogens and toxins, ranging from fungi to bacteria, viruses and parasites and it even binds antibiotic-resistant organisms.

This electron micrograph shows Staphylococcus aureus bacteria (artificially colored in yellow), whose surface has been bound by FcMBL protein coupled to magnetic beads after the enzyme-based method has exposed the sugar molecules that are recognized by FcMBL. Exposing the FcMBL-bead-covered bacteria to a magnetic field allows their rapid and efficient isolation for subsequent analysis. Credit: Wyss Institute at Harvard University.

Earlier studies by Ingber’s team have used FcMBL as the key component of a dialysis-like blood cleansing device for sepsis therapy. The Wyss Institute’s efforts focusing on pathogen capture in different applications are funded by the Defense Advanced Research Project Agency (DARPA).

"Given our exciting results pulling pathogens out of flowing blood using FcMBL, we asked whether we could also capture live bacteria from clinical samples for detailed molecular analysis," said Michael Super, Ph.D., a Wyss Senior Staff Scientist who helped lead this research effort.

As a starting point, the team investigated samples obtained from patients with infections of joints or joint replacements, where the pathogen Staphylococcus aureus can lead to painful inflammation or form bacterial biofilms that often render artificial surfaces into health hazards, leading to joint failure or sepsis.

"We showed that FcMBL-coated magnetic beads bound to 12 clinical S. aureus isolates after these were cultured from infected joint fluids and that we could isolate them using magnets; however, in our initial studies, the FcMBL-beads did not bind S. aureus directly in infected joint fluids. We then realized that immune cells and factors in patient samples mask the sugar molecules on bacteria that FcMBL usually binds to. This, together with the viscous nature of the complex clinical samples impeded the efficacy of the fusion protein," said Super.

The team remedied both problems with a cocktail of enzymes. When joint samples are pre-treated with this cocktail, protease enzymes eliminated the interfering immune factors to expose bacterial surface sugars for FcMBL binding, while another enzyme in the mix, hyaluronidase, breaks down a class of large polymers that are responsible for the high viscosity of joint fluids.

"Using this approach, we were able to isolate and concentrate pathogenic S. aureus cells in only 2 hours, which could make a tremendous difference in clinical settings, especially in cases where pathogens can not be cultured straight out of the sample. This could let us fast-track the best antimicrobial treatment option in often critical situations," said Alain Bicart-See, M.D. the study’s first author who as a Wyss Institute Visiting Scholar collected the samples at Hospital Joseph-Ducuing in Toulouse, France where he specializes in infectious diseases.

After their isolation, pathogenic bacteria can be molecularly identified with methods that either look for the presence of DNA snippets specific for candidate pathogens or identified by mass spectrometry, a technique that can survey all pathogenic proteins present in a sample. The Wyss researchers also think that the method will facilitate antibiotic susceptibility testing since bacteria retrieved with the method are alive.

"This isolation technique should be able to be used to rapidly identify pathogens in other clinical samples including blood, urine, sputum, and cerebral spinal fluid, and thus, it will hopefully shorten the time required for physicians to select the optimal therapy. In addition to saving more lives, this new method also should reduce the use of broad-spectrum antibiotic therapies, or suboptimal regimens, and thereby, decrease development of antibiotic-resistant organisms that become a more general threat in the long run," said Ingber.

Source: Wyss Institute at Harvard

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Advanced Airborne Pathogen Detection Technology Comes to America

Disinfection Services LLC, the North American distributor for Ireland-based NuWave Sensors, will launch the PathogenALERT RAPID Reader System (Rapid Airborne Pathogen Identification and Detection) to US infection professionals at the 2016 APIC conference in Charlotte, North Carolina.

"The RAPID Reader System automatically detects infectious airborne contaminants before visual growth occurs. This provides valuable time to engage in corrective action before an outbreak takes place," stated Susan Skelton, owner of Disinfection Services.

The RAPID Reader is an on-site microbial detection sensor that remotely monitors airborne pathogens (bacteria, yeasts and molds), radically altering the present approach to pathogen detection and control.

The RAPID Reader draws an air sample into a nutrient-rich detection site engineered to determine the presence of specific microbial contamination.  Sensors connected to the cloud-based monitoring system send text and email alerts whenever…and wherever… contamination is detected.

Stephen Daniels, inventor and co-founder of NuWave Sensors, states that reducing infection risks and costs are a key benefit to users.  "Implementing the RAPID Reader should have a significant impact on the effective management of airborne pathogens, resulting in lower overall costs for detection, infection risks, and remedial actions."

Continuous, on-site monitoring significantly shortens contamination detection times from days to hours, and automates the pathogen sampling, monitoring and detection process.  Cloud-based software provides daily reports, detailing current and historical risk levels using a similar format to traditional reporting techniques. The RAPID Reader eliminates the high expense and risk caused by current sampling methods that require long delays and external laboratory analysis.

"The PathogenALERT RAPID Reader system is a great stand-alone detection tool," said Skelton, "Our clients are able to simply detect pathogens on-site and on-time, and can also bundle one or more RAPID Readers with advanced UVC disinfection technology to detect, alert, and destroy airborne pathogens before an outbreak occurs. The ultimate goal is to help reduce pathogen transmission and infection to improve patient outcomes."

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Laser Scatterometer Distinguishes Wild Type, Mutant Bacteria

A laser scatterometer tool has been demonstrated to quickly and noninvasively detect harmful bacteria, including mutant listeria varieties, within 24 hours. It holds promise for the identification of mutant bacteria, and could be used to identify mutant bacteria from natural settings such as from contaminated food.

The method — dubbed BARDOT for bacterial rapid detection using optical scattering technology — could be quicker than conventional methods for studying microbial pathogenesis, a labor-intensive process involving the development, growth and genetic analysis of mutant bacteria strains.

BARDOT scans bacteria colonies looking for patterns unique to each bacterium. When the light penetrates a bacteria colony, it produces a scatter pattern that can be matched against a library of known bacteria patterns to identify a match. The system can identify bacteria such as salmonella, listeria, bacillus, vibrio and E. coli within 24 hours.

Now researchers from Purdue University have shown that BARDOT can pinpoint small genetic mutations in listeria.

"This is a versatile microbiology tool, and we wanted to see if we can use it for mutant strains," said professor Arun Bhunia said. "This is a really powerful tool to help researchers find those mutant strains much easier on a petri plate. You can avoid the laborious techniques required to screen or detect these mutant strains."

Mutant bacteria can be used to understand the biology of pathogens and how to combat dangerous outbreaks in food. The laser system enables visual comparison of the scatter patterns of wild type bacteria with those of mutant bacteria, for example, those that have had a gene deleted. The reverse was also true; by restoring the deleted gene, the BARDOT system recognized the bacteria as a regular wild type of strain.

The researchers reported that among the biophysical parameters examined, the colony height and optical density did not reveal any discernible differences between the mutant and wild type strains, meaning BARDOT could be used to screen and enumerate mutant strains separately from the wild type based on differential colony scatter patterns.

The research was published in Applied and Environmental Microbiology.

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Ebola Test From J&J's Janssen Earns FDA Emergency Use Authorization

The FDA has issued emergency use authorization (EUA) for Johnson & Johnson (J&J) subsidiary Janssen’s real-time diagnostic device indicated for the Ebola Zaire virus, which was responsible for the 2014 outbreak in West Africa. Using only a few drops of blood, the device can deliver results in less than two hours, and its cartridges are designed for easy transit and safe disposal.

The outbreak of Ebola in West Africa has claimed the lives of over 11,000 people since beginning in March of 2014, but has slowed considerably in recent months. The World Health Organization (WHO) recently announced that the Republic of Guinea — one of three countries most affected by the outbreak — had been free from Ebola transmission for over 42 days. Infectious disease experts have emphasized the need for heightened surveillance to detect new cases before they have a chance to spread.

On Aug. 4, 2014, the secretary of the U.S. Department of Health and Human Services (HHS) issued a determination that justified the emergency use of in vitro diagnostic devices capable of detecting the Ebola virus. Until that decision is revoked, devices meeting criteria outlined by the HHS may be made clinically available in U.S. laboratories without the rigorous application process required for traditional FDA approval.

Since 2014, ten medtech companies have received EUAs from the FDA for devices that could quickly and accurately diagnose Ebola, and many of these use a real-time reverse transcription polymerase chain reaction (rRT-PCR) system. Roche received an EUA last year for LightMix, and Cepheid introduced a point-of-care system with an available Xpert Ebola Assay.

The most recent addition is Janssen’s rRT-PCR system, the Idylla Ebola Virus Triage Test, which was co-developed with Biocartis NV and the Belgium Institute of Tropical Medicine.  Janssen Medical Director Theresa Pattery told the Philadelphia Inquirer that the device requires only a few drops of blood from patients, and takes approximately 100 minutes to distinguish between Ebola and other diseases that present with similar symptoms.

Janssen noted in a press release that the sample cartridges do not require cold-chain reagent storage and can be easily decontaminated before disposal. The test is available for use in U.S. laboratories and similarly qualified non-US laboratories where personnel have received training on the use of the Idylla system. According to Janssen, training required for the Idylla is minimal.

“We are very pleased that the FDA has granted Emergency Use Authorization for the Idylla Ebola Virus Triage Test,” commented Jorge Villacian, CMO of Janssen Diagnostics. “Across J&J, we are mobilizing our resources and expertise to help prevent another outbreak of Ebola.”

Because of difficulty in obtaining samples from patients with the Ebola virus, the Idylla test and many of its competitors have only been tested with lab-engineered specimens and not humans.  In 2015, Harvard researchers studied the use of both traditional rRT-PCR tests and Corgenix’s ReEBOV antigen rapid test in West Africa.

In a study published in the Lancet, researchers noted that the rRT-PCR tests are an imperfect benchmark in the field, and more testing is required to determine the efficacy of these tests in patients still in the early stages of the disease. Janssen noted similar limitations for Idylla in its press release.

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Device Can Diagnose Malaria in 5 Seconds

Malaria, which affects 200 million people each year, is one of the deadliest diseases in the world.
Although it is preventable and curable, the World Health Organization estimates that 438,000 people died from malaria in 2015, mostly in sub-Saharan Africa.

John Lewandowski, a PhD student in mechanical engineering at MIT, said diagnosing it quickly is critical.

"Early detection is very important, typically in the first five to seven days before symptoms arise, so that treatment can begin," said Lewandowski, 26.

He's designed a mechanical device called RAM (Rapid Assessment of Malaria) that is able to detect malaria in five seconds from a drop of blood.

There are two primary ways to diagnose malaria: You can test a drop of blood under a microscope to identify the parasite, or you can do a diagnostic test on a blood drop sample, which returns a positive or negative result, similar to a home pregnancy test.

But many rural communities in Africa and Asia don't have the medical infrastructure for microscopic tests, and the diagnostic test can't detect malaria infection in the very early stages.

Lewandowski developed his device to make diagnosing malaria quicker and cheaper.

The RAM is battery-operated, costs about $100 to $120, and is made from low-cost materials. The plastic box (measuring 4x4 inches) has a small circuit board, a few magnets and a laser on the inside. On the outside is an LCD screen, an SD card slot and a plastic disposable cuvette.

"It's pretty bare bones," said Lewandowski, who's the founder and CEO of Boston-based Disease Diagnostic Group, which is developing the device.

Malaria parasites in human blood create iron crystals that are magnetic in nature.
"As an engineer, I thought about creating a way to detect these magnetic crystals quickly," said Lewandowski.

You take a finger prick of blood and insert it into the box through the cuvette. If the malaria parasite is present, the magnets draw the iron crystals horizontally, vertically or diagonally. The laser helps identify the pattern and diagnose the disease. (If the disease isn't present, no crystals form.)

The technology is deliberately simplistic and easy to use, although diagnosing the parasite and determining treatment needs to be done by a local clinic or hospital.

"The technology is novel," said David Sullivan, a professor at Johns Hopkins University and an expert on "hemozoin," or the iron crystals. Sullivan, who is familiar with the device, said it offers a slight advantage over the rapid diagnostic tests because of its speed; some malaria patients can die within 24 hours.

Rapid blood testing devices have been in the spotlight recently. Most prominently, Theranos, which claimed its blood testing device could process a full range of lab tests with just few drops of blood.
The firm was valued at $9 billion, but in October 2015, a WSJ report questioned the accuracy of Theranos' blood tests and it has been under fire since then.

But Lewandowski said his device isn't reinventing the wheel.

"Our technology is just speeding up that same process and bringing down the cost," he said.

At the same time, he said the company is exploring how the technology could pivot to test for other mosquito-borne diseases like dengue fever and Zika virus.

Since 2013, Disease Diagnostic Group has tested the RAM device in clinical trials in India.

"In India, the field study of 250 patients showed a 93% to 97% accuracy," Lewandowski said, adding that a new field study will launch this summer in Nigeria with up to 5,000 patients.
The startup has won about $1.5 million from various business competitions, including the MIT $100K Pitch Competition and the Harvard Life Science Accelerator.

"We self-funded initially and the rest of our investment is from prize money and grants," said Lewandowski. He said the firm has six full-time employees and operates a lab and testing facility in Buffalo, New York.

The startup is already selling the devices in limited quantities to doctors in small clinics and individual healthcare workers doing malaria field tests in India.

The firm has submitted the device for approval to the WHO and for EU health and safety certification.

Lewandowski expects to have RAM devices more widely available for purchase in a year, and eventually in the hands of families in high-risk regions of the world for malaria.

"For us, social impact is our mission," he said. "We want them to be used in the right way by the right people who need them the most."

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Luminex Receives CE-IVD Mark for ARIES Flu A/B & RSV Assay

Luminex Corporation announced that it has received CE-IVD  status under the European Directive on In Vitro Diagnostic Medical Devices for the ARIES® Flu A/B & RSV Assay. Designed for use with the FDA cleared and CE-IVD marked ARIES® System, the ARIES® Flu A/B & RSV Assay is a rapid and accurate method for the detection and differentiation of three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) using a sample to answer platform.

"The ARIES® Flu A/B & RSV Assay provides a rapid, automated and cost-effective way to inform actionable treatment decisions and manage outbreaks in markets accepting CE marking for clinical use," said Thomas Pracht, Luminex's Managing Director for EMEIA. "Combined with our comprehensive respiratory test menu, we believe the ARIES® Flu A/B & RSV Assay provides the most flexible and complete clinical algorithm for improved patient outcomes."

This is the second assay this year for which Luminex has received CE-IVD marking for use on the new ARIES® System. The company received CE-IVD marking for the ARIES® HSV 1&2 Assay in March 2016, and FDA clearance in October 2015, along with clearance of the ARIES® instrument system.

The ARIES® System is a sample to answer molecular diagnostic system designed to increase laboratory efficiency, ensure result accuracy, and fit seamlessly into today's lean laboratory environment. ARIES® uses internal barcode scanning and other advanced features to minimize operator errors. Two independent modules each support from one to six cassettes, allowing for both STAT and Batch testing of IVD and homebrew assays using MultiCode® Reagents when using a common Universal Assay Protocol. An integrated touchscreen PC eliminates the need for a separate computer, standalone keyboard, and mouse, maximizing valuable bench space.

The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid from nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

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UK Grants Support Novel Methods of Combating Resistant Infections

Researchers at the University of Bristol received a grant to develop a rapid diagnostic test that can predict what type of antibiotic should be used to treat infection, according to a press release.

In addition, another grant was awarded to other university researchers to create nanopatterned surfaces that can kill antibiotic-resistant bacteria.

Both grants — AMR Theme 2: Accelerating Therapeutic and Diagnostics Development Innovation Grants — are designed to “support untested, high-risk/high-reward research,” the release said. They are funded by a consortium of four United Kingdom research councils.

“Bacteria defeat antibiotics in many ways, but most produce enzymes — machines that destroy antibiotics,” Matthew B. Avison, PhD, senior lecturer in microbiology at the university’s School of Cellular and Molecular Medicine, said in the release. “If we identify these enzymes in an infection, we can alert doctors to steer clear of certain antibiotics, and focus on the ones most likely to work.”

Avison will focus on developing a rapid diagnostic test to predict which antibiotic should be used initially. This test would help physicians prescribe effective antibiotics, while preventing over-reliance on the strongest antibiotics.

Bo Su, PhD, professor of biomedical materials in the School of Oral and Dental Sciences, received the second grant to create nanopatterned surfaces that can kill antibiotic-resistant bacteria.

“Biomaterials-associated infection is one of the dominant causes of implant failure,” Su said. “Currently, antimicrobial biomaterials are largely reliant upon antibiotics and antimicrobial agents. However, a critical drawback is that they are transient.

“Inspired by nanostructured surfaces found on insect wings, which kill bacteria through physical rupture of their cell walls, we hope to develop such novel antimicrobial surfaces that will be used for next-generation biomedical devices and implants.”

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Meta-Genomics Analysis Tool Taxonomer Can Rapidly and Accurately Detect Pathogens

Scientists at the University of Utah, ARUP Laboratories, and IDbyDNA, Inc., have developed ultra-fast, meta-genomics analysis software called Taxonomer that dramatically improves the accuracy and speed of pathogen detection. In a paper published today in Genome Biology, the collaborators demonstrated the ability of Taxonomer to analyze the sequences of all nucleic acids in a clinical specimen (DNA and RNA) and to detect pathogens, as well as profile the patient's gene expression, in a matter of minutes.

Infectious diseases are one of the biggest killers in the world. Almost 5 million children under age 5 die each year from infectious diseases worldwide, yet many infections are treatable if the pathogen culprit can be quickly and accurately identified.

"In the realm of infectious diseases, this type of technology could be as significant as sequencing the human genome," says co-author Mark Yandell, PhD, professor of human genetics at the University of Utah (U of U), H.A. & Edna Benning Presidential Endowed Chair holder, co-director of the USTAR Center for Genetic Discovery, and co-founder of IDbyDNA. "Very few people have inherited genetic disease. But at some point, everyone gets sick from infections."

It is difficult for infectious pathogens to hide when their genetic material is laid bare. Taxonomer opens up an entirely new approach for infectious disease diagnosis, driven by sophisticated genomic analysis and computational technologies. After a patient's sample is sequenced, the data are uploaded via the internet to Taxonomer. In less than one minute, the tool displays a thumbnail inventory of all pathogens in the sample, including viruses, bacteria, and fungi. The interactive, real-time user interface of Taxonomer is powered by the IOBIO system developed by the laboratory of Gabor Marth, DSc, professor of human genetics at the U of U and co-Director of the USTAR Center for Genetic Discovery.

"Our benchmark analyses show Taxonomer being ten to a hundred times faster than similar tools," says co-author Robert Schlaberg, MD, Dr Med, MPH, a medical director at ARUP Laboratories and cofounder of IDbyDNA. Schlaberg was awarded a $100,000 grant from the Bill and Melinda Gates Foundation to apply Taxonomer toward decreasing high mortality rates of children with infectious diseases in resource-limited settings.

Schlaberg points out that current diagnostic testing still relies heavily on growing cultures of suspected pathogens in the laboratory, which is often inconclusive and time consuming. Even with much faster tests like PCR, the number of pathogens that can be detected is limited.

Schlaberg explains that Taxonomer can identify an infection without the physician having to decide what to test for, something a PCR-based test cannot do. In other words, a doctor doesn't have to suspect the cause of a patient's infection, but can instead simply ask, "What does my patient have?" and Taxonomer will identify the pathogens.

In the new study, Taxonomer was put to the test with real-world cases using data published by others and samples provided by ARUP Laboratories and the Centers for Disease Control and Prevention (CDC). Taxonomer determined that some patients who exhibited Ebola-like symptoms in the recent African outbreak did not have Ebola but severe bacterial infections that likely caused their symptoms. "This technology can be applied whenever we don't know the cause of the disease, including the detection of sudden outbreaks of disease. It is very clear we urgently need more accurate diagnostics to greatly enhance the ability of public health response and clinical care," says Seema Jain, MD, medical epidemiologist at the CDC.

Another unique feature of Taxonomer is its ability to delve into human gene expression profiling, which provides information on how or if the patient's body is reacting to an infection. "As a clinician, this gives you a better idea, when we identify a pathogen whether it is really the cause of the disease," says Carrie L. Byington, MD, professor of pediatrics of the U of U and co-director of the Center for Clinical and Translational Science. "This tool will also allow us to determine if the patient is responding to a bacterial or viral infection when we don't find a pathogen or when we find multiple potential causes." She says that she sees the exceptional value of this tool for treating children, who experience more life-threatening infections early in life. "Seeing how a host [patient] reacts is extremely valuable; I believe this is a paradigm shift in how we diagnose people. It is why I wanted to be involved."

In a previous paper published in the Journal of Clinical Microbiology, Schlaberg and his collaborators demonstrated that high-throughput sequencing in combination with Taxonomer can reliably detect pathogens, and identify previously missed pathogens, in patient samples. "Taxonomer provides a critical step forward, as it is extremely fast, accurate, and easy enough to use for implementation in diagnostic laboratories," says Schlaberg.

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Spartan Bioscience Unveils the World’s Smallest DNA-testing Device

Spartan Bioscience today introduced the Spartan Cube, the world’s smallest commercial molecular diagnostics device that enables unprecedented portability and convenience.

The Cube is exceptionally small—it takes up the space of a coffee cup. At only four inches cubed in size, the Cube fits easily into any space, whether in a hospital, doctor’s office, or pharmacy.

The device’s simple design enables anyone to quickly perform DNA testing. It connects wirelessly to a tablet or laptop that displays test instructions and results with an intuitive touch interface. In addition, the Cube goes from sample to result in a fraction of the time compared to traditional lab-based testing. Doctors, patients, and other users can get immediate results rather than waiting for a lab to run a test.

The Spartan Cube is a PCR-based platform for a variety of molecular diagnostic applications, including infectious disease, pharmacogenetics, and food and water testing. Spartan Bioscience will showcase the Spartan Cube and announce an initial assay menu at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo on July 31, 2016 in Philadelphia, P.A.

Paul Lem, M.D., CEO of Spartan Bioscience, says the Spartan Cube is taking the complexity out of DNA testing.

“The Spartan Cube is a revolutionary molecular diagnostics platform. It enables rapid DNA testing with a device so portable, you can literally hold it in the palm of your hand,” says Dr. Lem. “Whether you want to quickly test a sick patient in a doctor’s office or run a genetic test for drug response—the Spartan Cube will provide results when and where you need them.”

Spartan Bioscience is the leader in on-demand DNA testing.(1) Spartan is bringing complete sample-to-result DNA-testing systems to medicine. Spartan’s technology fully integrates DNA collection, extraction, and analysis, with an intuitive interface that is easy to operate. For the first time, healthcare providers and their patients can get DNA results on demand.

1. Roberts JD et al. (2012). Lancet. 379:1705–11.

Note: The Spartan Cube is for research use only. Not for use in diagnostic procedures.

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bioMérieux Acquires Hyglos and Expands its Offering to the Detection of Endotoxins

bioMérieux, a global player in in vitro diagnostics and world leader in industrial microbiological control, announces the acquisition of Hyglos, a Bernried (Germany) - based company specializing in the detection of endotoxins. Founded in 2009, Hyglos has a unique and recognized expertise in the development and production of recombinant proteins used for the detection of endotoxins in pharmaceutical products.

Endotoxins are a component of the outer membrane of certain Gram-negative bacteria. They are pyrogenic substances, i.e. they cause high fevers. Pharmacopoeial standards require that this type of substance be absent from pharmaceutical products that come into contact with the bloodstream or the central nervous system such as injectable drugs or medical devices. It is also recommended that the endotoxins be quantified in raw materials such as water, or work-in-process materials.

Today, endotoxin detection relies on the use of reagents developed based on a purified blood fraction taken from a horseshoe crab (Limulidae), a family of crab endangered in Asia and protected in the United States and whose blood has the ability to coagulate in the presence of minute amounts of bacterial endotoxins.

Hyglos has developed an innovative method from recombinant proteins, which eliminates the need for horseshoe crab blood and thus allows for the detection of the presence of endotoxins using a chain of completely standardized reactions. Moreover, when certain formulations are used in the manufacturing of biotechnological medicines, they can hide or "mask" endotoxins; Hyglos has developed a unique and original technology for "demasking" endotoxins, i.e. making endotoxin detection possible, even in such cases.

“Hyglos’ expertise in the field of recombinant proteins opens new horizons for the detection of endotoxins. True to our pioneering spirit, we are convinced of the relevance of its innovative method. Its existing product portfolio has enriched our offering of microbiological control solutions for the pharmaceutical industry and medical devices", states Nicolas Cartier, Head of bioMérieux's Industry Unit.

Dr. Wolfgang Mutter, Managing Director of Hyglos, adds: “We are very pleased to join bioMérieux. Its global leadership in industrial microbiological control and the scope of its commercial network creates promising perspectives that allow pharmaceutical manufacturers to benefit from the scientific and technical soundness of the products that we have developed for reliable and efficient endotoxin detection.”

The endotoxin detection market is today estimated at €250 million, an increase of around 12% per year[1], particularly supported by the growth in the volume of drugs derived from biotechnology, medical devices and vaccines.

The total consideration paid by bioMérieux to acquire 100% of Hyglos shares will amount to €24 million, phased over the next 3 years. The transaction was closed on May 31, 2016.

Hyglos will be consolidated in the Group’s financial statements from June 1st, 2016.

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