Tuesday, January 23, 2018


TECHLAB, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the CAMPYLOBACTER QUIK CHEK™ and the CAMPYLOBACTER CHEK™ tests. Both are intended to aid diagnosis of campylobacteriosis, one of the most common causes of diarrheal illness in the United States. The CAMPYLOBACTER QUIK CHEK™ test is a rapid diagnostic test that detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes. The CAMPYLOBACTER CHEK™ test is a 96-well plate format for laboratories testing large numbers of specimens, and can be used with or without automation. The CAMPYLOBACTER CHEK™ and CAMPYLOBACTER QUIK CHEK™ tests have accuracies that surpass culture and have the highest positive predictive values (PPV) among currently available Campylobacter immunoassays.

"Most Campylobacter testing is still performed by culture because the diagnostic immunoassays on the market have a PPV value of less than 50 percent.  But culture requires up to 72 hours to give a result and is technically challenging due to the microaerophilic growth requirements of the bacteria," said Dr. Joel Herbein, VP of Scientific Affairs at TECHLAB. "The Campylobacter products we have developed have a high PPV, can be performed on the benchtop in 30 minutes for the rapid to about an hour for the 96-well plate format, and offer clinicians more confidence in their testing results."

Campylobacter is a foodborne pathogen and is estimated to affect more than 1.3 million people annually in the United States. (1) The CAMPYLOBACTER QUIK CHEK™ and CAMPYLOBACTER CHEK™ tests offer quick and reliable detection of Campylobacter-specific antigen in human fecal specimens.


1. Centers for Disease Control (2017, Oct. 2). Campylobacter (Campylobacteriosis). https://www.cdc.gov/campylobacter/faq.html.

Atomo Diagnostics and Access Bio Partner to Expand Access to Best-in-Class HIV Rapid Testing

Atomo Diagnostics and Access Bio Inc. today announce a strategic partnership to leverage the respective strengths of both innovative rapid diagnostic test (RDT) companies to expand point of care HIV testing in global markets.

The partnership will see Atomo supply its award-winning AtomoRapid™ lateral flow diagnostic test platforms for use with Access Bio’s in vitro HIV rapid test that detects the presence or absence of HIV antibodies in a single drop of blood obtained from a fingertip. The test result can be read in minutes, which is essential for same day diagnosis and early treatment and care.

The new test product will be commercialised by Access Bio in professional use markets under its CareStart™ brand in territories across Africa, South East Asia, South America and CIS countries. In September 2016, the World Health Organisation (WHO) forecast that demand for HIV rapid diagnostic tests in the territory will increase by one third, to reach more than 400 million tests per year by 2020.

Dedicated to the prevention and early diagnosis of infectious diseases, Access Bio and its subsidiary, Wells Bio Inc., manufacture more than 120 million rapid diagnostic tests annually for the detection of a range of infectious diseases, including malaria, dengue and HIV. The new partnership with Atomo Diagnostics will strengthen its rapid test portfolio and support continued growth.

“Access Bio is delighted to announce our new strategic partnership with Atomo Diagnostics which will add to and enhance our existing rapid test range,” said Young Ho Choi, CEO and Founder of Access Bio. “Atomo’s all-in-one test devices, which simplify and standardize test procedures, will help us improve the performance and user-friendliness of our HIV test for our customers. Access Bio’s HIV test strips combined with Atomo’s test devices will also offer an innovative solution to support the HIV 90-90-90 campaign. This alliance with Atomo is highly compatible with our established business channels, and we are actively exploring other areas of collaboration to strengthen our portfolio in the mid-to-long term.”

Founder and CEO of Atomo Diagnostics, John Kelly, adds, “We are excited about this commercial partnership with Access Bio, a recognised market leader in rapid diagnostic testing. Our AtomoRapid™ platforms are proving their excellent usability and performance for a range of applications internationally, and this new partnership adds significantly to our long-term growth plans. Moreover, it demonstrates our continued commitment to tackling HIV by enabling greater access to best-in-class diagnostics in areas hardest hit by the disease.”

WHO estimates that in 2016 there were approximately 36.7 million people living with HIV around the world, with a further 1.8 million people being newly infected. Screening and prompt diagnosis have a critical role to play in ending the HIV/AIDS pandemic. Although there is no cure for HIV infection, effective antiretroviral (ARV) drugs can control the virus and help prevent transmission so that people with HIV, and those at substantial risk, can enjoy healthy, long and productive lives.

About Atomo

Atomo Diagnostics is a world leader in medical device design and development, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specialises in pioneering rapid diagnostic test (RDT) solutions for use with capillary blood samples. The recipient of multiple international awards for innovation, Atomo’s all-in-one AtomoRapid™ handheld device platforms put the end user first and make it easy to test and screen for a range of infectious diseases and chronic conditions. Unlike standard, multi-component rapid test kits, AtomoRapid™ platforms integrate features and functionality, incorporating a sterile safety lancet, calibrated blood collection system, and unique buffer delivery mechanism.

About Access Bio

Access Bio (KOSDAQ: 950130) is dedicated to the prevention and early diagnosis of infectious diseases through research, development, and manufacturing of in vitro rapid diagnostic tests, biosensors and molecular diagnostic products. The company’s in vitro diagnostic test platform includes immunochemical, biochemical and molecular products.

Headquartered in Somerset, New Jersey, Access Bio serves its global customer base from manufacturing sites located in the U.S., Ethiopia, and South Korea. In 2016, the company reported $28.0 million of revenues, largely from sales of its industry-leading malaria RDT products. The company has commercially launched a number of additional diagnostic tests that leverage its industry-leading expertise and manufacturing capacity.

Alveo Eyes Point-of-Care Diagnostics Market With Microfluidic Infectious Disease Testing Platform

Having recently closed a $38 million Series A financing, startup Alveo Technologies plans to use the funding to commercialize its infectious disease diagnostic platform.

The company's infectious disease panels can simultaneously detect multiple different viral pathogens at a low cost, with the ability to easily scale up to 100 microreactors to find subtypes of certain diseases.

Founded in 2014, the Alameda, California-based firm plans to combine isothermal amplification with electrochemical detection, to quickly and cheaply identify infectious diseases from patient samples using technology developed by Alveo CEO and Founder Ron Chiarello and Cofounder Larry Blatt. Blatt's previous company Alios BioPharma developed drugs that targeted human respiratory syncytial virus (RSV) before the company was acquired by Johnson & Johnson for $1.75 billion. The pair began to to develop dedicated tests to detect viral nucleic acid biomarkers and recruited Michael Aicher as Alveo Cofounder and President to help commercialize their technology.

Alveo's platform includes microchips with different infectious disease panels that can run simultaneously on its smartphone-sized device. The firm's chips integrate sample prep, isothermal amplification of genetic material, and real-time detection into  single microfluidic channels.

The company's tests target viral and bacterial genetic material using a fixed temperature amplification process in plasma, mucous, or whole blood samples, followed by electrochemical detection of the amplified DNA. According to Chiarello, the combination of isothermal amplification, a simplified electrical detection scheme, and microfluidics allows ease of use and lower costs.

"We can have many of these microreactors on a single chip, and are currently building chips with 10 microreactors," Chiarello explained. "But we can scale up to 100 conveniently, allowing us the flexibility to test for multiple subtypes of a given pathogen or target, combine multiple panels, increase redundancy, or detect more viruses or bacteria simultaneously."  

Alveo is currently developing three panels for detecting viruses and one panel for bacterial infections. The first viral panel, made for chronic viruses, tests for HIV, hepatitis A-C, and parvovirus. The second panel, which will detect viruses commonly found in mosquitos, includes dengue, chikungunya, and the Zika virus. The third panel, focusing on acute respiratory viruses, will detect respiratory syncytial virus, influenza A, and influenza B. Alveo's bacterial panel will detect tuberculosis and potential variants.

"Our current panels are for specific customer requests, with Alveo being formed to address voids they need filled," Aicher explained in an email. "Each individual target is independently designed for the specific pathogen by utilizing a conserved region [of pathogens' DNA] to detect all subtypes."

Depending on the number of bacteria or viral load per sample, Chiarello estimates that Alveo's panels will detect pathogens in five to 10 minutes for someone who is visibly ill. In contrast, the test will require around 20 minutes to determine if a patient does not have the pathogen.

Alveo claims that the panels' sensitivity and specificity are strong and comparable to bulkier PCR-based devices used in hospitals and research facilities, but the company has yet to publish data supporting this.

According to Aicher, the company anticipates different commercial strategies depending on the partners they collaborate with in the next 12 to 18 months. Currently building beta units, the firm plans to have products in the field for research use in the second half of 2018. Aicher believes that units will most likely be placed in facilities that are more point-of-care or point-of-donation, rather than research facilities.

"We have great relationships with the [University of California] system and other universities, but we are pushing more for being closer to our commercial application for beta-use than we are in research applications," he explained.

Hesitating to comment on a price, Aicher said that a number of factors will determine the cost of the overall platform, such as the number of viruses included in the panel. However, he does believe that it will be "significantly less than any device on the market" and estimates the cost for the test will be somewhere "in the single digits optimally," and the "readers themselves will be very inexpensive."

While the company declined to disclose most of the investors who participated in the Series A funding round besides Maxim Merchant Capital, Chiarello said that they included "high network industry insiders and technology experts."

Because of the platform's flexibility and portability, Chiarello envisions that the device will be used in locations where inexpensive, rapid diagnosis is of benefit for infectious disease detection.

"We are motivated to make sure the battery operated device can be used anywhere, especially in developing regions where you have unreliable power," added Chiarello.

Monday, January 22, 2018

New Paper Test Can identify Contaminated Water

Scientists have developed a simple, paper-based device that can be used to test if a water sample is contaminated, providing a low-cost way for developing countries to limit the spread of water-borne diseases.

Inspired by the simplicity of litmus paper - commonly used for the rapid assessment of acidity in water - the device consists of a microbial fuel cell (MFC), obtained by screen printing biodegradable carbon electrodes onto a single piece of paper.

An MFC is a device that uses the natural biological processes of 'electric' bacteria - attached to the carbon electrodes - to generate an electric signal.

When these bacteria are exposed to polluted water, a change in the electric signal occurs, which can be used as a warning message that the water is unsafe to drink.

Researchers from the University of Bath in the UK are now investigating how to link up the sensor with an electronic device such as a mobile phone, via a wireless transmitter, for a quick and user-friendly way of identifying if a water supply is safe to use.

The device has the potential not only to make water assessment rapid and cheap - each device is expected to cost no more than USD 1 - but it is also environmentally friendly since the paper sensor is made of biodegradable components.

The device is also easy-to-use and transport, weighing less than one gramme.

"This work could lead to a revolutionary way of testing water at the point of use, which is not only green, easy to operate and rapid, but also affordable to all," said Mirella Di Lorenzo, senior lecturer at the University of Bath.

"This type of research will have a significant positive impact, especially benefiting those areas where access to even basic analytic tools is prohibitive," said Di Lorenzo, lead author of the study published in the journal Biosensors and Bioelectronics.

"This device is a small step in helping the world realise the United Nations call to ensure access to safe drinking water and sanitation as a human right," she said.

Abaxis Announces USDA Approval of New VetScan FLEX4 Rapid Test

Abaxis, Inc. (NasdaqGS: ABAX), a global diagnostics company manufacturing point-of-care instruments and consumables for the medical and veterinary markets worldwide, today announced that the USDA, Center for Veterinary Biologics, approved its new VetScan FLEX4 Rapid Test for veterinary use. The FLEX4 is a 4-in-1 lateral flow test used for the qualitative detection of Heartworm antigen as well as antibodies for Lyme, Ehrlichia and Anaplasma in canine whole blood, serum, or plasma samples.

The FLEX4 Rapid Test is the newest addition to the VetScan Rapid Test product family.  The VetScan FLEX4 Rapid Test offers improved shelf-life, ease-of-use, room temperature storage, and price when compared to competing products. Veterinary clinics and hospitals now have a 4-in-1 alternative for vector-borne disease testing on a single cassette.  As with all other VetScan Rapid Tests for infectious diseases, results can be easily read by the user within 8-10 minutes.  Abaxis plans to begin shipping FLEX4 Rapid Tests to its distributor network later this quarter and the FLEX4 should be available to U.S. veterinarians shortly thereafter.

Craig Tockman, Vice President of Animal Health Sales and Marketing for North America of Abaxis, stated, "As a veterinarian, it is always important to have the option to choose quality diagnostic products for our valued clients and their pets.  We believe the FLEX4 Rapid Test will benefit many practices and hospitals looking for a new alternative that is accurate, has longer shelf-life, is less expensive, and easier to use. In addition, our strategic distributor partners are excited about this product and are prepared to get this new rapid test into the veterinary marketplace."

Clint Severson, Chief Executive Officer of Abaxis, said, "The USDA approval of the VetScan FLEX4 Rapid Test is an important achievement. It fully opens the door for Abaxis to successfully compete in this $100 million+ annual market. At Abaxis, we strive to be a leading innovator in the point-of-care diagnostics segment, and we believe the new FLEX4 Rapid Test, a 4-in-1 canine test, fits that mold. We pride ourselves on providing better, innovative solutions for our valued customers and we believe this is a significant win for our customers.  Now, veterinary practices and hospitals have a diagnostic option that embodies the standard of excellence for which Abaxis is known. We believe the FLEX4 Rapid Test provides a better diagnostic solution for the pet and its owner and the veterinary practice. We look forward to the opportunities ahead."

Along with the multiplex FLEX4 Rapid Test, Abaxis will continue to sell the single test platform currently available for Heartworm disease, Lyme disease, Ehrlichiosis, and Anaplasmosis.  Many veterinarians praise the flexibility of the single Rapid Test line because they can test based on disease prevalence in their region or use individual tests to verify treatment outcomes at the point-of-care.  With the addition of the FLEX4, the veterinarian now has increased flexibility to test infectious diseases according to their preference.

Thursday, January 18, 2018

An eNose Is Able To Sniff Out Bacteria That Cause Soft Tissue Infections

A recent study conducted at the University of Tampere, Tampere University of Technology, Pirkanmaa Hospital District and Fimlab in Finland has concluded that an electronic nose (eNose) can be used to identify the most common bacteria causing soft tissue infections.

The eNose can be used to detect the bacteria without the prior preparation of samples, and the system was capable of differentiating methicillin-resistant Staphylococcus aureus (MRSA) from methicillin-sensitive Staphylococcus aureus (MSSA).

Skin and soft tissue infections are common diseases that need medical treatment. Their diagnosis is usually based on bacterial cultures, but in uncomplicated cases the diagnosis may be made directly based on the clinical presentation of the disease. However, this may lead to empirical antibiotic treatments, i.e. treatments without a specific diagnosis, which may result in longer treatment times, adverse effects and increased costs.

"Our aim was to create a method for the rapid diagnosis of soft tissue infections. If we had such a method, treatment could be started in a timely manner and targeted to the relevant pathogen directly. This would reduce the need for empirical treatments and shorten diagnostic delays," says doctoral researcher Taavi Saviauk from the Faculty of Medicine and Life Sciences at the University of Tampere.

"The portable eNose device we used does not require laboratory conditions or special training, so it is well suited for outpatient use. The results of this study are a significant step towards our goal," Saviauk continues.

An electronic nose is a device that produces "an olfactory profile" for each molecular compound in the air. The results are analysed by a computer and the system is programmed to differentiate between different compounds.

The research group conducting the study has previously shown how an eNose can be successfully used to differentiate prostate cancer from benign prostatic hyperplasia using a urine sample and distinguish between the various bacteria that cause urinary tract infections.


Taavi Saviauk, Juha P. Kiiski, Maarit K. Nieminen, Nelly N. Tamminen, Antti N. Roine, Pekka S. Kumpulainen, Lauri J. Hokkinen, Markus T. Karjalainen, Risto E. Vuento, Janne J. Aittoniemi, Terho J. Lehtimäki, Niku K. Oksala. Electronic Nose in the Detection of Wound Infection Bacteria from Bacterial Cultures: A Proof-of-Principle Study. European Surgical Research, 2018; 1 DOI: 10.1159/000485461

Harvard-Led Team Develops Handheld Device for DNA, RNA Amplification, Detection

Researchers at Harvard University and non-profit Diagnostics for All have combined electrochemical detection with recombinase polymerase amplification (RPA) on a portable device to improve detection of genetic material from multiple tuberculosis strains.

In the study, published last month in Analytical Biochemistry, the team aimed to simplify the amplification and electrochemical detection of genetic material at the point of care, showing that coupling isothermal RPA assays with an electrochemical readout allows accurate and rapid detection of genes. The study was partly funded by the Gates Foundation and the Defense Threat Reduction Agency of the US Department of Defense.

Originally developed by TwistDx, now part of Alere, and soon to be part of Abbott, RPA is a DNA/RNA amplification technology that can act as  an alternative to PCR. It is especially attractive in low-resource settings because it does not require a relatively expense thermal cycler.

The RPA reaction uses enzymes called recombinases that form complexes with oligonucleotide primers and pair the primers with homologous sequences in DNA. A single-stranded DNA binding protein binds to the displaced DNA strand and stabilizes the resulting loop. The primer then initiates DNA amplification by a polymerase, but only if the target DNA sequence is present.

According to the study, the team's platform uses disposable, paper-based strips that integrate three screen-printed carbon electrodes and accomplish thermoregulation with +/-0.1 ºC temperature accuracy. The universal mobile electrochemical detector (uMEDNA), described in a paper published in 2014 in the Proceedings of the National Academy of Sciences, enables electrochemical detection of the amplified DNA using a variety of pulse sequences, and is easy enough to use with minimal training and supervision. The strips can be used with the UMEDNA or electrochemical analyzers, both benchtop or portable.

Maria-Nefeli Tsaloglou, then a postdoc at Harvard funded by Marie Curie Actions, and senior author of the latest study explained that the researchers have been developing the basic diagnostic device since 2010. Her team is working to commercialize both the paper strip, electrochemical detection technology, and proprietary uMEDNA device that performs the RPA assay. Roughly the size of a smartphone, the device provides components and algorithms to control the DNA amplification and perform electrochemical detection at the same time.

To detect DNA, the team first prepares the paper test strip that includes the blood sample and primers, in addition to integrated electrodes that contain the reagents for RPA. The test strips allows the team to cut down on reaction volume, reducing reagent cost and blood sample size. After identifying a 213-bp region common to both Mycobacterium tuberculosis and Mycobacterium smegmatis, the team designed appropriate primers for the RPA assay to amplify the specific sequence.

Performed at 65 ºC, the assay combined isothermal amplification with electrochemical readout of redox-active hexa-amine ruthenium (III) (Ru(NH3)6]3+) as an electroactive mediator for the electrochemical detection of DNA.

Tsaloglou and her colleagues also performed the reaction with varying levels of initial concentrations of the M. smegmatis target DNA in order to demonstrate the assay's sensitivity. According to the study, the assay's limit of detection is 0.04 nanograms/microliter, equating to 11 CFU/ml of M. tuberculosis.

Because RPA assays do not need additional sample prep time, the assay in the study required 20 minutes to identify the biosignal. Tsaloglou emphasized that the RPA assay could potentially identify the signal faster depending on the type of primer and target sequence.

Data that the uMEDNA device collects can be transmitted by plugging it into a cell phone's headphone jack. Tsaloglou explained that the uMEDNA device also communicates with any bluetooth-enabled device and can link to any computer, tablet, or smartphone. At the moment, the researchers have developed software for Apple devices and are currently working on adapting the program for Android devices.

While the team used M. smegmatis as a surrogate strain for M. tuberculosis, the benchtop RPA assay Tsaloglou and her colleagues developed can detect up to 19 Mycobacterium species. In addition, the team also carried out experiments using samples spiked with M. tuberculosis DNA that highlights that the electrochemical method also works with the specific bacterial strain.

The Harvard researchers have filed a joint patent with Diagnostics for All for the electrochemical detection of nucleic acids on a portable reader using paper-based disposable strips. Harvard chemistry professGeorge Whitesides, corresponding author on the new study, founded Salem, Massachusetts-based Diagnostics for All in 2014 to order to focus on healthcare and diagnostics in the developing world. The patent describes use of electrochemistry for deteciton RPA or other isothermal methods.

The non-profit has partnered with the Harvard lab to explore low-cost applications for the paper-based uMEDNA device.

In terms of commercialization, Tsaloglou explained that the lab is working on a prototype reader, which is currently in alpha stage. Tsaloglou's team has partnered with undisclosed experts in the electronics industry to move to beta and commercial rollout, and is seeking additional partners. She foresees research use within a year, and commercial use by 2020, provided the team is able to secure additional necessary partners and move the platform through regulatory approval as planned.

Detecting pathogens using genetic biomarkers is a well known method employed by multiple companies, with Cepheid being one of the most well-known examples for tuberculosis detection. Cepheid's GeneXpert MTB/RIF assay has been endorsed by the World Health Organization for diagnosing active tuberculosis, and demonstrates strong performance in detection of rifampin susceptibility and resistance.

The researchers noted, though, that GeneExpert is limited to the lab and is too expensive for most applications in the developing world and at the point of care.

Tsaloglou said that the uMEDNA device will only cost the end user about $30. Introducing the DNA detection paper-based strips will keep keep the assay price relatively low, as well.

"Electrochemical analyzers in the lab are bulky, expensive, almost in the range of $300,000 to $1 million," she said. "In the paper, we proved that the size and electronics within the analyzer can be cheaper."

Tsaloglou believes that the RPA assay could perform well in resource-limited areas due to its isothermal nature. According to Tsaloglou, running the assay on the inexpensive portable device in the developing world will allow accurate tuberculosis detection with little sacrifice to sensitivity or accuracy. The device could also potentially be used to identify a variety of infectious diseases in rural clinics, country borders or ports, and eventually at home for lifestyle monitoring, she noted.

Battelle Wins IARPA Contract to Develop Genetic Threat Identification Software

Battelle announced that it has been awarded a contract by the US government's Intelligence Advanced Research Projects Activity (IARPA) to develop software to assess the threat potential of genetic sequences.

The contract was awarded as part of IARPA's Functional Genomic and Computational Assessment of Threats program, which is focused on developing methods and tools for screening nucleic acid sequences, as well as the functional annotation and characterization of genes of concern, to prevent the creation of biological threats.

Battelle said it will design software that can predict the function of a DNA fragment based only on its sequence, and which can be used to screen DNA sequences to determine whether they are related to any known organisms, predict the function of unknown sequences, and assign a threat level based on the potential for harm.

"Biotechnology is more accessible than ever, with internet-accessible products and services enabling advances in numerous industries," Trevor Petrel, director of advanced technology development at Battelle, said in a statement. "The exponential growth in capability of genetic engineering, as well as accessibility to these biological tools, requires that we rethink conventional biosecurity to evolve with the rapid pace of technology. Genetic engineering tasks that previously took weeks and considerable skill to accomplish now require less effort, skill, and technical resources."

Battelle said that it is working with industry collaborators, including Ginkgo Bioworks, One Codex, and Twist Bioscience, to develop the software and gain insights into its use in real-world settings.

The financial terms of the contract were not disclosed.

In September, IARPA awarded Signature Science a $2.9 million contract to develop new computational tools to screen DNA sequences to detect biological threats that may arise from synthetic microbial manipulation.

Cepheid Receives FDA Clearance and CLIA Waiver for Xpert® Xpress Flu Test

Cepheid announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the Xpert® Xpress Flu test. The test can be performed in near-patient settings, providing rapid and accurate molecular detection of Flu A and B RNA from patient specimens, in as little as 20 minutes.1

The Xpert Xpress Flu test is also indicated for use with nasal swabs, in addition to nasopharyngeal (NP) swabs. Nasal swab collection is less invasive than NP swabs and allows for a more comfortable specimen collection experience for the patient.

"Our Xpert Xpress family of tests is designed to provide rapid results paired with uncompromising performance. They offer an easy-to-use format that delivers actionable results at the point of patient impact," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert Xpress Flu is the first highly sensitive PCR test on a CLIA waived multi-module system designed for greater surge capacity and menu versatility."

According to the World Health Organization, infections of the upper respiratory tract represent the most common reason for antimicrobial use. The vast majority of such infections are of viral origin and do not require treatment with antimicrobials.2 "Xpert Xpress Flu provides medically actionable and timely information to clinicians to support improved patient management, and antibiotic and antiviral stewardship," continued Dr. Persing.

The new GeneXpert® Xpress Systems and Xpert Xpress Flu test extend access to standardized molecular testing for any healthcare setting — from community hospitals to physician offices and specialty clinics for no-compromise speed, accuracy, and quality. Xpert Xpress Flu utilizes automated real-time reverse transcription polymerase chain reaction (RT-PCR) to detect Influenza A and B RNA. The tests capability to detect multiple segments of RNA improves strain coverage and prevents loss of sensitivity as natural variations (antigenic drift and shift) of the Influenza virus occur. The built-in reagents deliver high accuracy in an automated format with no additional confirmation testing required.

Saturday, January 06, 2018

New Diagnostic Test Could Help Detect Respiratory Viral Infection Faster

According to a study published in the Journal of Infectious Diseases, a new test that measures mRNAs or proteins in human nasal epithelial cells could prove to be a quicker way to diagnose respiratory viral infections than current methods.

Upper respiratory illnesses are common, yet there is no rapid diagnostic test to confirm more than a handful of common viruses as the cause.

To identify biomarkers of viral infection applicable to many different respiratory viruses, Yale University researchers Dr. Ellen Foxman and Dr. Marie Landry tested human nasal cells in the laboratory.

With genetic sequencing techniques, the researchers screened the cells for mRNAs and proteins that increase when a virus is present.

They identified three mRNAs (CXCL10, IFIT2, and OASL) and two proteins (CXCL11 or CXCL10) that are ‘turned on’ by a virus.

They then investigated whether measuring the expression of the genes, or levels of the proteins, could predict the presence of a viral infection.

The team found that the mRNAs and proteins were both accurate predictors of respiratory viral infection, confirmed by subsequent testing for common viruses.

The mRNAs predicted viral infection with 97% accuracy.

“Our method also picked up viruses that are not identified by many current lab tests,” the authors noted.

“Instead of looking for individual viruses, our test asks the question: ‘Is the body fighting a virus?’” Dr. Foxman said.

“We found we can answer that question very well.”

The scientists hope to develop the method into a rapid gene or protein test that doctors could perform in their offices.

Such a test could help providers diagnose a viral infection more quickly and accurately than with routine evaluation or more time-consuming and expensive tests.

The test could be particularly useful for assessing very sick patients or young children and it could also help reduce the misuse of antibiotics to treat viral infections.

“One reason to test is to know why the patient is sick. The other reason is to make a decision about whether people who are not that sick should get antibiotics,” Dr. Foxman said.

“Our goal is to create a gene- or protein-based test available for general use within one to five years.”


Marie L. Landry & Ellen F. Foxman. Antiviral response in the nasopharynx identifies patients with respiratory virus infection. Journal of Infectious Diseases, published online December 21,2017; doi: 10.1093/infdis/jix648

Four Groups Get Longitude Funds for Point-of-Care Tests

The Longitude Prize has named the latest winners of funding for the development of point-of-care diagnostic tests that will conserve antibiotics.

The United Kingdom–based seed funding program, launched in 2014 to address the problem of antibiotic overuse and resistance, announced this week that four teams from India won the third round of Discovery Award funding, with each team receiving awards from £10,000 to £25,000 ($13,355 to $33,388) to work toward prototype development and validation of their tests. The Longitude Prize has now awarded funding to 29 different teams from around the world.

Three teams focus on sepsis

Three of the newly awarded teams are developing tests that could help reduce morbidity and mortality due to sepsis, a condition that occurs when the body's reaction to infection triggers an inflammatory response throughout the body. IDI Group is developing an ultrasensitive magnetic biosensor to rapidly detect and identify endotoxins in the blood, an innovation that could help clinicians treat sepsis in its early stages and choose the right antibiotic therapy.

NanoDX Healthcare is evaluating Septiflo, a low-cost, disposable kit that can detect bacteria in a drop of blood in under 10 minutes and stratify patients based on whether the bacterial infection is caused by a gram-negative or a gram-positive pathogen. The company says the device is intended for use in rural and urban settings and doesn't require trained physicians or a microbiology laboratory.

SpotSense is conducting validation of a non-invasive, sputum-based test for diagnosing neonatal sepsis, which accounts for nearly a quarter of all newborn deaths in India. The device tests for levels of sepsis biomarkers in neonatal saliva and then uses an algorithm to calculate a sepsis score. The team says the device can also be used to evaluate severity and guide antibiotic therapy and can be utilized by nurses or midwives without the need of a pathology lab.

Companion AST, or cAST, is developing a new imaging device to perform rapid point-of-care diagnosis of antibiotic-resistant bacteria in urinary tract infections. The low-cost imaging tool generates antibiotic susceptibility reports directly from urine samples.

Discovery Award funding is intended to help researchers develop their ideas and compete for the Longitude Prize, which will be awarded to the team that can develop a transformative point-of-care test that will improve antibiotic treatment decisions—and help conserve antibiotics—by either ruling out unnecessary antibiotic use or identifying the most effective antibiotic. The test needs to be accurate, affordable, rapid, easy-to-use in all global healthcare settings, and ready for clinical performance trials.

Winners of the Longitude Prize will receive £8 million ($10.7 million).

Quidel Receives FDA Clearance and CLIA Waiver for Point-of-Care Sofia® 2 Instrument for Use with Sofia Strep A+ Assay

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today it has received 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are one of the more common causes of acute upper respiratory tract infection.

Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented immunoassay diagnostic solution that addresses the specific testing needs of the decentralized point-of-care (POC) market. Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, automated and objective result in 5 minutes.

Sofia 2 integrates a barcode scanner and wireless connectivity within a smaller footprint than the legacy Sofia instrument. The next-generation Sofia system also comes connected to Virena®, Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time.

The Sofia Strep A+ assay employs advanced lateral flow and immunofluorescence technologies to provide enhanced clinical sensitivity for Group A Streptococcus, one of the more serious respiratory diseases in children and seniors. These technologies help ensure a reliable, objective, rapid, and accurate diagnostic result. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and serious complications such as rheumatic fever and glomerulonephritis. (1, 2)

"With the clearance of Sofia Strep A+, Sofia 2 now provides clinicians at the point-of-care with a powerful diagnostic tool that quickly and accurately diagnoses three of the more common respiratory diseases: Influenza A+B, RSV and Strep A. We believe that the Sofia 2 solution is a perfect fit for the specific needs of the point-of-care space, especially as we continue to develop and add incremental assays to the Sofia 2 ecosystem,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Sofia 2 will build on the successful legacy of our original Sofia flagship product by expanding our instrument placements into the smaller, lower volume physician offices as well as the higher volume health systems, while also significantly growing our Virena wireless coverage throughout the country.”

Sofia Strep A+ is the third CLIA-waived assay available on the Sofia 2 system. Sofia 2 is CLIA-waived for use with the Sofia Influenza A+B assay as well as the Sofia RSV assay, for the detection of Respiratory Syncytial Virus.


1. American Academy of Pediatrics. [Group Streptococcal Infection]. In : Pickering L.K., Baker C.J ., Kimberlin D.W., Long S.S ., eds. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: America Academy of Pediatrics; 2009:617-628

2. Youmans G.P., Paterson P.Y., and Sommer H.M., Upper Respiratory Tract Infection: General Considerations, in the Biological and Clinical Basis of Infectious Disease, W.B. Saunders Co., Philadelphia, 1980, pp. 177-183

CERTUS™ to Bring In-House Salmonella Testing to Food Processing Plants

CERTUS™, innovators in food safety technologies, announced the expansion of its rapid food pathogen detection menu with the initiation of research and development of an Environmental Salmonella assay. To address a pathogen which, according to the CDC causes more than one million food-borne illnesses in the United States annually, the new CERTUS Salmonella test will use the same proprietary Surface Enhanced Raman Spectroscopy (SERS) technology and instrument platform as the company’s CERTUS EL test for Listeria, which is due to launch in early 2018. End-use benefits will similarly include extremely simple workflow, on-site testing capabilities, real-time growth monitoring, immediate alerts upon detection and bio-containment for the safety of the food processor and consumer. As with the CERTUS Listeria assay, the Salmonella test will be, “All-in one, all in-house.”

“CERTUS remains committed to developing tools to help food producers protect consumers from the world’s most dangerous pathogens,” says CERTUS President, John Coomes. “Salmonella continues to plague the food industry in large numbers, so we’re excited to develop an in-house solution for small and mid-sized food processing plants and address a true need in the market. Our customers will realize greater value with the CERTUS system now that they will be able to run both environmental Listeria and Salmonella in the same instrument.”

As with the CERTUS EL test, the CERTUS Salmonella assay is being designed to run in a single enrichment media, homogeneous no wash format. This means that no sample manipulation is required and that the assay tube never has to be opened once the sampling swab is inserted. The assay will be delivered in a Bio-Lock™ tube/cap design that cannot be opened after enrichment begins thus securing the environment from accidental contamination. This feature, combined with the target time-to-result goal of less than 24 hours, enables food producers to move testing on-site for significantly faster results.

Reagent research and development is being conducted in collaboration with CERTUS research partner, Solus Scientific, a UK-based food pathogen assay developer. Solus Scientific is the developer and manufacturer of their own Listeria, Salmonella and E. coli ELISA designed for large volume sample processing. Solus is also the assay development partner for the CERTUS EL assay used in the CERTUS System which is currently seeking AOAC validation.

Indian Startups Developing Rapid Tests to Help Check Antibiotic Resistance

Overuse and misuse of antibiotic drugs has given rise to disease-causing bugs developing resistance. In order to provide effective treatment for various infections, it has become necessary to quickly find out if an infection-causing agent is resistant or susceptible to drugs. Four research startups with innovative ideas have been selected for research grants to develop such rapid tests.

The Discovery Award seed funding, totaling 200,000 dollars, will help four Indian research groups to develop their ideas into prototypes and products and also bid for an international prize called the Longitude Prize. The £10 million five-year Longitude Prize launched in 2014 will be given to the best point-of- care test to detect infections to help ensure that the right antibiotics are used at the right time. The Discovery Awards in India are funded by the Biotechnology Industry Research Assistance Council in India (BIRAC).

The new ideas awarded this year include an imaging device to perform rapid diagnosis of antibiotic resistant bacteria for urinary tract infections, by a group called as cAST. This team is working on an automated device which could be operated without the help of a trained lab technician to generate antibiotic susceptibility reports from urine samples. The proposed device will able to detect small features of a bacterial cell which can help determine viability of the cell.

Bangalore-based IDI Group has been selected for the award to develop an ultrasensitive magnetic biosensor to detect and identify bacteria in blood, which would help treat sepsis during its early stages. The magnetic biosensors will be able to detect bacteria from blood without culture or amplification reaction.

Another Bangalore group, Spotsense, is working on developing a test for diagnosing sepsis in newborns, assessing its severity and guiding antimicrobial therapy. The prototype is similar to a thermometer, which can also be used for testing for other severe infections in very small babies. The device tests for levels of biomarkers for sepsis in neonatal saliva and then uses an algorithm to calculate a normalised score for sepsis.

NanoDx Healthcare, based in New Delhi, will utilize the grant to work on a disposable rapid endotoxin detection kit for use at the patient’s bedside. It will provide results in less than 10 minutes and also give an indication about severity of infection. The detection is based on a colorimetric response that changes with the extent of infection in blood.

“One of the main reasons for inappropriate use of antibiotics is lack of availability of reliable rapid diagnostic tests that help doctors to differentiate between a bacterial infection that needs an antibiotic and a viral infection. A rapid diagnostic test should also inform doctors on the right antibiotic that can be used to treat a bacterial infection. Such a test should be cost effective and affordable to health care systems in developing countries,” Dr Abdul Ghafur, an international expert on antibiotic resistance, told India Science Wire.

“The lack of reliable rapid tests mean that people do not know when and if they need antibiotics. We need accurate point-of- care diagnostic tools to maximise the chances that antibiotics are only used when medically necessary,” said Daniel Berman of Longitude Prize team at Nesta. “Indian start-ups can be part of a global solution in this field,” added Dr Renu Swarup, Managing Director, BIRAC. (India Science Wire)

Tangen Biosciences Awarded Contract to Develop a Field-deployable Anthrax Diagnostic Assay

The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), has awarded Tangen Biosciences a contract to develop a field-deployable Anthrax diagnostic assay.

This contract will advance and expand the ability to combat the threat of Bacillus anthracis by utilizing the TangenDxTM Molecular Diagnostic System, which is a rapid, sensitive, low cost, and fully portable molecular diagnostic platform. The high sensitivity, portability, and speed provided by the Tangen platform will allow for earlier and more accurate diagnosis of this deadly infection, allowing for more effective treatment and improved tracking of outbreaks.

The contract with BARDA will fund the development and commercialization of the TangenDxTM instrument platform, along with the Tangen assay disk, and Tangen’s proprietary rapid sample processing technology. In addition, under this contract Tangen will be developing assays to rapidly detect genomic markers of antibiotic resistance for a range of other bacterial threats.

This is a 3-phase, 3.5-year project, which is expected to result in an FDA 510(k) submission for clearance of the Anthrax assay. Phase one of the contract, which commenced in October 2017, is valued at $3.2MM, followed by two optional phases valued at an additional $6.2MM.

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700028C.

About Tangen Biosciences:

Tangen Biosciences is a pilot stage diagnostic instrument company that has developed a group of novel technologies that have been incorporated into a rapid (<1hr), mobile (<1 Kg), easy-to-use, and extremely sensitive molecular diagnostic platform.  The performance parameters of the TangenDxTM system sets it apart from competitors, and will allow it to rapidly diagnose a variety of sepsis causing pathogens directly from whole blood.  In addition, the TangenDxTM platform can simultaneously perform up to 33 different assays on a single patient sample, enabling cost effective syndrome-based diagnostic panels.