Thursday, November 12, 2015

BioFire Defense Ebola Test Fares Well in Sierra Leone, UK Evaluation

A research team from the UK has determined that a rapid molecular Ebola assay from BioMérieux subsidiary BioFire Defense is sufficiently sensitive and specific to be an attractive option for relatively low-throughput laboratories testing for the disease.

However, the assay and accompanying platform may not yet be suitable in outbreak situations or in labs with relatively high testing throughput, the researchers suggested.

Rapid and specific testing is critical for patient care in suspected cases of Ebola virus infection, but rigorous evaluation of the numerous molecular diagnostics that have received Emergency Use Authorization from the US Food and Drug Administration is ongoing.

Since August of 2014, eight molecular diagnostics for Ebola have been authorized. These include the FilmArray NGDS BT-E Assay and Biothreat-E test from BioFire Defense, which have been the subject of at least three peer-reviewed evaluations since mid-July of this year.

The most recent study of the BioThreat-E test, published online last week in the Journal of Clinical Microbiology, was a collaborative effort of the Defence Science Technology Laboratory, Public Health England, and the Centre of Defence Pathology in the UK.

The group tested samples as they became available during the Ebola crisis last year. These included 44 patients in Sierra Leone as well as 70 patients in the UK who had symptoms and had recently traveled to West Africa. During that period, the rare and imported pathogens lab at PHE saw a 10-fold increase in testing frequency, although the majority of patients were not infected with Ebola, the study noted.

Importantly, the evaluation deviated from the BioFire FilmArray protocol by adding a heating step prior to testing of 60 °C for 15 minutes. This was intended to inactivate the virus and enable the assays to be performed at lower biological safety levels.

According to Simon Weller, first author on the JCM study and a researcher at DSTL, the three agencies had different aims in conducting the evaluation.

"From a defense perspective, we have an interest in low operative and logistic burden diagnostic technologies — the FilmArray fits neatly into this area — and therefore the Ebola outbreak was an opportunity to test such a platform in a real-world setting," Weller told GenomeWeb in an email.

Meanwhile, from a public health perspective, there was a requirement to enhance the UK capability to rapidly test suspected patients closer to where they presented for diagnosis, Weller said, noting that most regional PHE labs didn’t operate an Ebola testing service prior to the outbreak.

"The FilmArray was a candidate for a means to rapidly put a safe and sensitive testing capability into these regional labs," he added.

The study compared the FilmArray Biothreat E-test to a published TaqMan-based real-time PCR assay. That assay had been optimized and validated previously by  for use in the UK and Sierra Leone, and included a bacteriophage internal control, Weller said.

The BioThreat-E test showed comparable performance to the validated PCR, with a sensitivity of 84 percent and specificity of 89 percent in the Sierra Leone samples, and a sensitivity of 75 percent and specificity of 100 percent in the samples from the UK.

This difference between the sites was likely a function of different prevalence of Ebola in the two countries and the relatively low sample numbers, rather than a performance or geographic characteristic, Weller said.

There were also nine discrepant results, potentially attributable to waning viral load and inhibitors present in whole blood.

Safely handling patient samples that could be infected with Ebola is always a concern. The comparator RT-PCR required a centrifugation step, which can potentially create aerosols.

"Within the small isolators in Sierra Leone — the only containment available there — there was a significant operative and temporal penalty in having to centrifuge," Weller explained.

"There was a lot of packaging in the isolators from unpacking samples; blood then had to be transferred to microtubes for centrifugation and then plasma had to be transferred to a fresh microtube for inactivation and RNA extraction — it took a while to do, even with practice."

The BioThreat-E test, on the other hand, used only 200 microliters of whole blood.

Disposal of waste and cleaning the platform is also important. In Sierra Leone, test pouches were double bagged and put into a clinical waste stream for immediate on-site incineration, Weller said, while in the UK they were autoclaved prior to incineration.

"How to disinfect a platform and then be able to subsequently use it is something we have an interest in," he said, adding, "We didn’t experience a pouch split in our testing and, in any case, put in an inactivation step prior to PCR."

And while the one-hour BioThreat-E test was found to be an "attractive option" for lower-throughput testing, it may not meet requirements for outbreak situations.

"When I was in Sierra Leone, we routinely had batches of 40 samples or more," Weller said. "These would be unsustainable to test on the FilmArray — it would be very costly and take too long."

He noted that in his experience of Ebola testing, there were bottlenecks in the unpacking of samples, generating plasma to test, and EBOV inactivation, all of which must be performed in a small isolator, as well as in the manual RNA extraction and PCR.

"An integrated platform [that performs] RNA extraction and PCR [and] which is able to test whole blood samples and run samples concurrently might be an interesting thing to evaluate," he said. A rapid diagnostic test that also included viral inactivation steps would be interesting as well, he suggested, although overall the researchers found the general microbiological screening capability of the FilmArray very useful in Sierra Leone.

In the future, the three labs will use whichever test or technology is best for the particular scenario they are faced with, as the FilmArray "is a very useful tool but only as part of a wider microbiological [and] virological testing capability," Weller said.

However, he said that he would hope the international community has now evaluated enough platforms and technologies for Ebola testing, and that it has enough experience to be able to rapidly deploy the best technologies and approaches in any future Ebola outbreak.

"Hopefully there will not be one on the same scale again," he said.

Researchers Launch Bloodless Urine-based Malaria Test

Scientists working in Nigeria have developed a new test for malaria using urine which they hope will become mainstream soon in compliance with national guidelines to test before treating for malaria.

The urine malaria test (UMT), developed by Fyodor Biotechnologies, doesn’t require use of blood unlike existing rapid diagnostic test for malaria.

Speaking at the launch of UMT in Abuja, Dr Victoria Enwemadu, Fyodor’s global head of projects, told Daily Trust, “There are some challenges with adopting that [national malaria testing] guideline mainstream because of the invasiveness of trying to get blood for testing. Now we have made it easier by just using urine to test for malaria.”

The UMT includes a strip that is dipped into urine sample for 25 minutes to give results which can be read as positive, negative or valid, when compared against a control.

It is based on recombinant antibody technology which searches for malaria parasite in urine sample, and the strip indicates its presence or not, according to Dr Eddy Agbo, chairman of Fyodor.

“There should be no guesswork by any health provider as to whether a patient has malaria or not,” he added. “We have a game changer in our hands.”

UMT has taken seven years in the making, and involved Johns Hopskins University, University of Maryland and University of Nigeria, Nsukka in discovery, clinical development and analysis.

Researchers included partners at the National Malaria Elimination Programme recruited more than 2,000 people to take part in clinical trials for the test.

It is considered the “first full-scale clinical trial for a medical product ever undertaken in Nigeria,” according to Agbo.

Dr Bridget Okoeguale, director of public health at the federal health ministry, said FMOH would consider working with its Roll Back Malaria partners to push UMT as a do-it-yourself malaria test that does not require bleeding or pricking.

Fyodor has said it would use partnership with indigenous firm Geineth to make UMT available in hospitals, pharmacies, primary health centres and patent medicine stores around the country.

Western University Scientists Develop New Test to Detect E. Coli in Contaminated Food

Scientists at Western University have developed new technology that they believe has the potential to drastically improve food safety.

The new rapid-test system, developed by Dr. Michael Rieder, would allow manufacturers to more quickly identify food contaminated with a strain of E. coli before it leaves the processing plant, and enters the grocery store.

“The current method for developing bacteria like E. coli relies on culture and takes about 3 or 4 days to get a result, so we thought we could do better than that,” said Dr. Rieder.

“By the time the bacteria are identified, the food has been shipped to grocery stores and may have already caused illness. With this current system, two weeks of food may need to be recalled to ensure against cross-contamination.”

Dr. Rieder’s rapid-test system would allow food to be sampled at the end of one day, and the results would be available before the food is shipped the next morning.

“This means that one day’s production is lost, not five days production,” he said. “This has the potential to save companies considerable money, and more importantly could save a lot of people from being exposed to food-borne disease.”

The system was developed over the past five years as a result of collaborations between Dr. Rieder, scientist at Robarts Research Institute at Western University, and London entrepreneurs, Michael Brock and Craig Coombe.

The rapid-test relies on targeting proteins identified by Dr. Rieder’s lab that are only present in the organisms that cause people to become ill. By collaborating with Toronto-based company, International Point of Care, the team was able to use flow-through technology to mark the protein with colloidal gold so that it is visible to the naked eye. The process is similar to that used in pregnancy tests – one line for negative, two lines for positive.

“I’d like to think that at Robarts we deliver, so now we’ve got this product that’s out there and let’s see where it goes,” he said. “Our next target, by the way, is going to look at Listeria, so now that we’ve got E. coli solved, we’re going to start looking at other bacteria.”

The rapid-test system has completed testing at Robarts and the Health Canada-certified Agriculture and Food Laboratory at the University of Guelph. The final application has been submitted to Health Canada for approval.

On average, 440 cases of E. coli 0157 infection in humans are reported annually to the Public Health Agency of Canada.

Alere's SD BIOLINE HIV/Syphilis Duo is First Dual Test to Receive WHO Prequalification

Alere, a global leader in rapid diagnostics, announced that its Alere SD BIOLINE HIV/Syphilis Duo test has been awarded World Health Organization (WHO) prequalification, making it the first dual HIV/syphilis point-of-care test available for public sector procurement in resource-limited countries.

With WHO prequalification, global health organizations such as PEPFAR, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria can now deploy the HIV/Syphilis Duo test in national screening programs targeting those in greatest need. Utilization of the test will be focused on screening pregnant women for HIV and syphilis and linking those infected to care, in support of WHO's goal of eliminating mother-to-child transmission (EMTCT) of these serious diseases.

"Alere is committed to making our infectious disease diagnostics widely available to support prevention of mother-to-child transmission programs in resource-limited countries, and the WHO prequalification of HIV/Syphilis Duo test significantly advances this goal," said Avi Pelossof, Alere Global President of Infectious Disease. "With this broadened access, the full potential of the HIV/Syphilis Duo test in helping meet EMTCT goals can now be unlocked."

Her Excellency, Dr. Nana Lordina Dramani Mahama, First Lady of the Republic of Ghana and President of the Organisation of African First Ladies Against HIV/AIDS, said, "Alere has already provided test kits to help us screen 200,000 people for HIV and syphilis infections, and we are delighted that this productive relationship continues to grow and thrive."

About Alere SD BIOLINE HIV/Syphilis Duo

The Alere SD BIOLINE HIV/Syphilis Duo offers a simple, easy-to-use rapid diagnostic test for simultaneous detection of HIV and Syphilis. By enabling early detection of HIV, Syphilis or both in mothers, the Alere SD BIOLINE HIV/Syphilis Duo helps bridge the health equity gap and get patients onto treatment pathways faster. The test uses a solid-phase immunochromatographic assay for simultaneously qualitative detection of HIV-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum, plasma, or whole blood.

About Mother-to-Child Transmission of HIV and Syphilis 

Globally, 1.4 million pregnant women have active syphilis and almost 1.5 million pregnant women are HIV infected. Both HIV and syphilis can be transmitted during pregnancy to the fetus. Additionally, syphilis infection during pregnancy increases the risk of mother-to-child HIV transmission by 180%.[1]  In sub-Saharan Africa, 260,000 African children are infected with HIV each year. Mother-to-child transmission occurs through pregnancy, labor, delivery and breast feeding. In fact, breast-feeding alone increases the risk of MTCT by 12%-43%.[2]  Maternal syphilis infection can cause stillbirth, neonatal death, prematurity, low birth weight or congenital syphilis. The impact of maternal syphilis can be prevented by testing early in pregnancy, treating seropositive pregnant women, and preventing re-infection.[3],[4]

Forty percent of pregnant women living with HIV have not received anti-retrovirals to reduce mother-to-child transmission during pregnancy.[5] Without any intervention, up to 45% of infants born to mothers living with HIV will become infected.[6]

In 2014, WHO and key partners published guidance on and recommendations for the dual elimination of mother-to-child transmission of syphilis and HIV, and a framework for countries to monitor progress and validate success.[7]

[1] Mwapasa V, Rogerson SJ, Kwiek JJ, et al. Maternal syphilis infection is associated with increased risk of mother-to-child transmission of HIV in Malawi. Aids 2006; 20(14): 1869-77.

[2] Maputle MS, Jali MN. Pregnant women's knowledge about mother-to-child transmission (MTCT) of HIV infection through breast feeding. Curationis. 2008;31(1):45-51.

[3] De Santis M, De Luca C, Mappa I, et al. Syphilis Infection during pregnancy: fetal risks and clinical management. Infectious diseases in obstetrics and gynecology 2012; 2012: 430585.

[4] Gomez GB, Kamb ML, Newman LM, Mark J, Broutet N, Hawkes SJ. Untreated maternal syphilis and adverse outcomes of pregnancy: a systematic review and meta-analysis. Bulletin of the World Health Organization 2013; 91(3): 217-26.

[5] 2013 Progress Report on the Global Plan. UNAIDS 2013.

[6] UNICEF, Unite for Children, Unite Against AIDS. Towards an AIDS-Free Generation, report highlights. Children and AIDS, Sixth Stocktaking Report 2013.

[7] World Health Organization (WHO). Global Guidance on Criteria and Processes for Validation: Elimination of Mother-to-Child Transmission of HIV and Syphilis. 2014. Available online at

Researchers Successfully Test New Method for Rapid Diagnosis of Ebola in Guinea

An international team of researchers, including Ahmed Abd El Wahed, scientist at the University of Göttingen and the German Primate Center, has tested a new method for rapid diagnosis of Ebola in a field trial in Guinea. The test procedure was carried out using a portable suitcase laboratory. The mobile suitcase lab is operated with solar power and enables simple on-site diagnostics in remote areas without the need of an equipped laboratory. The new detection method, a recombinase polymerase amplification technique, shortly RPA, is based on the rapid identification of viral RNA in oral swabs of infected persons at 42 degrees. The comparison with two other currently available diagnostic methods revealed that the RPA is a very sensitive and rapid technique. An Ebola infection case was detected after 30 minutes. The results of the field study have been published in the current issue of the journal Eurosurveillance.

In the field study, which took place in Guinea from March to May 2015, oral swabs samples from persons suspected of dying of Ebola virus were analyzed. The scientists compared the new RPA with two variants of a currently available detection method, the so-called real-time polymerase chain reaction (PCR). "In the analysis we were able to determine two things", says Ahmed Abd El Wahed, currently in the Department of Microbiology and Animal Hygiene at the University of Göttingen and a guest scientist at the German Primate Center. "First, RPA works very well with oral swab samples, which greatly simplifies sampling in the future, because it is faster and less complicated than sampling blood. Second, we have demonstrated that RPA is as sensitive and specific as the gold standard, but technically much more simpler than the real-time PCR methods."

Nine hundred twenty eight oral swab samples were tested with RPA, one hundred twenty samples were positive and eight hundred eight negative. The reference real-time PCR method gave exactly the same results. "That is a 100 per cent accuracy", says Abd El Wahed. "In addition, we observed during the test that RPA even works better than a currently commonly used WHO approved real-time PCR for the detection of Ebola."

Both the PCR and RPA-tests are based on the identification of viral RNA in the serum or oral swabs of infected persons. In contrast to the real-time PCR, the RPA reagent can be shipped, stored and used at ambient temperature of Africa (up to 38 degrees), which makes them cold chain independent. After 30 minutes, the detection of Ebola with RPA is possible. In contrast, the real-time PCR usually takes several hours. This complicates the use of the method in remote areas. "In order to better control an Ebola epidemic, we must be able to prove infections on-site as early as possible", says Abd El Wahed.

In a previous project, Abd El Wahed, Manfred Weidmann and Frank Hufert of the former Department of Virology of the University Medical Center Göttingen (UMG) developed the laboratory suitcase. It now also contains all the necessary reagents and equipment needed for the Ebola virus detection by RPA and works up to 16 hours with solar power. A mobile glove box provides additional protection against infection with contaminated sample material.

"The mobile diagnostic kit facilitates detection of Ebola and other infectious diseases directly in the crisis areas", says Ahmed Abd El Wahed. "With the field study, we could now also demonstrate the effectiveness of the new tool. Speed, accuracy and ease of use are three important criteria that we were able to achieve with the new method. Thus, the procedure could contribute decisively to the management of future Ebola crises."

In future, the diagnostic kit is also to be used for the detection of other viral infections. For example, Dengue virus, Chikungunya virus and Rift Valley fever virus.

Huntsville Biotech Company Reaches Important Milestone with Deadly Bacteria Detection

Leaders at HudsonAlpha associate company iCubate believe they are one step closer to having its gram positive bacteria rapid identification test used by hospitals.

According to findings published in "The Journal of Clinical Microbiology," the iCubate iC-GPC assay was proven effective in a hospital setting. The device can identify infections including Staphylococcus. Researchers say these are among the most common bacterial contaminants of blood.

“These findings are an important milestone for the company. We are one step closer to having this product available to help healthcare providers better treat their patients,” says iCubate CEO Carter Wells.

The findings, which were published online and will appear in the journal's December print publication, discussed benefits using the iCubate assay.

"A potential benefit of the iC-GPC assay is the use of a single, closed-system consumable cassette. This enables simplified assay set-up (< 5 min. hands on time) and also aids in reducing the risk of aerosolization of potentially infectious organisms and amplicon contamination. Furthermore, the iC- Processor is capable of random-access processing of up to 4 iC-cassettes simultaneously using an instrument that has a small footprint. Combined, these attributes may positively impact safety, workflow, and throughput when compared to other currently available FDA- cleared molecular platforms and assays for the direct identification of bacteria present in positive blood cultures.”
While this gives the company positive momentum, there is a major hurdle iCubate needs to clear before the assay is used in hospitals -- FDA approval.

iCubate founder and chairman Jian Han, M.D., Ph.D., told Tech Alabama in January 2015 he believes the privately-held company will be worth hundreds of millions of dollars once it obtains an FDA 510(k) clearance.

“Combining the innovative arm-PCR technology pioneered by Han, along with our talented team members, iCubate is positioned for success in this growing market,” Wells explains.

A timetable on FDA clearance is unknown at this time.

New Tests Allow Quick Detection of Foodborne Bacteria

A new testing method developed by Abu Dhabi’s centralised laboratory will allow detection of foodborne and environmental bacteria much quicker, helping prevent and limit outbreaks of food-related diseases.

The Central Testing Laboratory (CTL) will now use a high-tech method with proteins that infect and multiply inside bacteria. This will enable the detection of some of the most common harmful foodborne pathogens, including Salmonella species, E. coli, Campylobacter species and Listeria.
The procedure will take less than 19 hours, compared to the four days required with traditional methods of detection.

“Pathogenic bacteria species such as these account for most food and water-related illnesses and outbreaks, resulting in many fatalities worldwide. The new capability puts CTL on par with the leading laboratories of the world and further augments Abu Dhabi’s capacity to control outbreaks of food borne diseases,” said Mohammad Al Baloushi, acting director for marketing and communication the Abu Dhabi Quality and Conformity Council (QCC). The QCC, which ensures the development of quality infrastructure in Abu Dhabi manages the CTL. The CTL itself is a merger of Abu Dhabi’s nine public laboratories.

The CTL’s current capabilities include testing of food, water, pharmaceuticals and construction materials.

Dr Krishna Murthy, director of Medeor 24x7 Hospital in the capital, said the new molecular testing method will allow for the rapid testing of foods and protect from possible pathogens being spread.
“With such advanced techniques, it is even possible to detect disease-causing bacteria that are present in very small quantities. So decisions to withdraw infected foods can be made accurately, thus keeping the community safe,” he explained.

The new detection method has also been accredited by the internationally accepted United Kingdom Accreditation Service.

T2Bacteria Panel Achieves Rapid and Sensitive Detection of Six Clinically-Relevant Bacteria Species Directly From Whole Blood

T2 Biosystems, Inc., a company developing innovative diagnostic products to improve patient health, announced that data on its investigational T2Bacteria Panel will be presented today at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.

"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for blood culture," said Mike Pfaller, M.D., chief medical officer of T2 Biosystems. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives."

"The use of T2Candida and T2Bacteria, when combined with the practice of empirically administering broad spectrum antibiotics, may typically enable 95% of patients with sepsis to receive rapid and appropriate therapy," said John McDonough, chief executive officer of T2 Biosystems. "We are excited that the data in this study demonstrate the potential of T2Bacteria to enable the reduction in the current mortality rate of bacterial sepsis by 50%."

About the Study

The T2Bacteria Panel is being designed to run on the T2Dx instrument in conjunction with the T2Candida Panel. To achieve similar clinical performance to the T2Candida Panel, published data show that the T2Bacteria Panel will need to achieve a limit of detection (LoD) below 10 CFU/mL for each species. T2MR was able to demonstrate a high analytical sensitivity and high specificity for all bacterial targets. A LoD as low as 1 CFU/mL was observed for the targeted bacteria species spiked into healthy blood. The LoD for all bacterial species tested was determined by the cell concentration (CFU/mL) that resulted in a 95% or greater detection rate for 20 samples.

Key finding:

Data demonstrate the T2Bacteria Panel's ability to achieve limits of detection below 10 CFU/mL, and as low as 1 CFU/ml, similar to the performance demonstrated for the T2Candida Panel, in six clinically relevant bacteria species.

The six bacteria in the T2Bacteria Panel were selected because when combined with the use of T2Candida and the practice of empirically administering broad spectrum antibiotics, the rapid detection of these bacteria may enable 95% of patients with sepsis to receive rapid and appropriate therapy. These bacteria comprise 55% of all positive blood cultures and have growing resistance profiles.

About T2Bacteria Panel  

The T2Bacteria Panel is being developed to provide a species-specific result in three-to-five hours, direct from whole blood, with no need for blood culture. Similar to the FDA-cleared T2Candida Panel, the T2Bacteria Panel will run on the fully automated T2Dx Instrument. To date, the T2Candida Panel has demonstrated 91.1% sensitivity, 99.4% specificity and limit of detection as low as 1 CFU/mL. Species-specific results are obtained in three-to-five hours versus 120+ hours for blood culture. To achieve similar performance, published data indicates that the T2Bacteria Panel would need to achieve a limit of detection below 10 CFU/mL for each species, which was demonstrated in this study.

About Sepsis

Sepsis is one of the leading causes of death in the U.S. and the most expensive hospital-treated condition, with costs to the healthcare system exceeding $20 billion each year, according to the U.S. Department of Health and Human Services. The T2Candida Panel uses T2 magnetic resonance (T2MR) technology to detect the presence of five clinically relevant species of Candida, the most lethal form of common blood stream infections that cause sepsis, directly from a patient's blood sample in approximately three-to-five hours, enabling physicians to make timely treatment decisions to reduce adverse outcomes, patient mortality, and costs.

About The T2Candida Panel

The T2Candida Panel is the first sepsis pathogen diagnostic that provides species-specific results in three-to-five hours without the need for blood culture, which can take up to six days to provide a result. The rapid detection of Candida enables physicians to provide targeted treatment quickly, and research has shown this can reduce a positive sepsis patient's length of stay in the hospital by almost nine days at a cost savings of approximately $26,887. A rapid negative result can prevent unnecessary administration of antimicrobials, further reducing costs. In addition, a rapid negative result can prevent or reduce antimicrobial resistance, which the Centers for Disease Control and Prevention has designated a serious threat.

Roche Expands cobas 4800 System menu with HIV-1, HCV and HCV Genotyping Tests

Roche announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark1. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions.

The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory.

"With the addition of these assays to the cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management," said Roland Diggelmann, COO, Roche Diagnostics." As the global market leader, we are also pleased to introduce cobas HCV genotype test which accurately identifies HCV genotypes and helps optimize treatment of hepatitis C patients."

The assays launched today will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System.

About the cobas 4800 System

The cobas 4800 System offers improved automation of nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency. The system now has a comprehensive test menu including the cobas HIV-1 Test, cobas HCV Test, cobas HCV Genotyping Test, cobas MRSA/SA Test, cobas HSV 1 and 2 Test, cobas C.diff Test, cobas CT/NG Test (chlamydia/gonorrhea), cobas HPV Test, cobas BRAF V600 Mutation Test, cobas EGFR Mutation Test, and the cobas KRAS Mutation Test.

About the assays for the cobas 4800 System - assays for viral load monitoring and genotyping

The three new virology assays can run simultaneously on the cobas 4800 System with two different sample processing volumes for HIV-1 and HCV (200 µL and 400 µL) and only 400 µL for HCV GT streamlining workflow while increasing flexibility for patient sample management.

cobas HIV-1 is built upon the dual-target assay design from Roche. The test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure, allowing for more reliable results to confidently and effectively quantify the amount of HIV-1 RNA in a patient's blood.

cobas HCV employs Roche's unique dual-probe approach to provide an extra layer of protection against mutations that can occur in the viral genome and is designed to accurately detect and quantify hepatitis C virus (HCV) ribonucleic acid (RNA) with state-of-the-art sensitivity in order to confirm active HCV infection or assess a patient's response to antiviral therapy.

cobas HCV Genotyping is a highly accurate and sensitive real-time PCR-based test for the qualitative identification of HCV genotypes 1 to 6 and genotype 1 subtypes a and b in human plasma or serum from individuals with chronic HCV infection. Identification of the infecting genotype is required before a patient is prescribed antiviral therapy as response to treatment correlates to the HCV genotype.

Sunday, November 01, 2015

Startup Qvella Gets Funding to Develop Rapid Pathogen Detection Test

It's been more than a decade in the making, but Qvella is close to the holy grail of diagnostics--a compact, inexpensive pathogen analyzer that identifies the precise culprit in only 30 minutes. The idea is to enable better infection treatment faster as well as to minimize the overuse of antibiotics, which leads to the development of resistance.

The company has gotten a $20 million Series A round that was co-led by RA Capital Management and Whitecap Venture Partners. Hatteras Venture Partners and Sands Capital Ventures also participated. The financing is intended to advance the development of its first test to detect pathogens, in whole blood, although the technology can also be used with other bodily fluids, as well as to build out its staff.

"Solutions that enable patients to receive the right treatment quickly will fulfill a key unmet need in microbiology," Parker Cassidy, Qvella board member and executive in residence at RA Capital Management, said in a statement. "Qvella has the perfect combination of technology, team, and potential to impact how antibiotics are delivered and developed." Cassidy was previously the VP of Continuous Glucose Monitoring at Becton Dickinson.

The development of the technology for the test started in 2003 at UCLA's David Geffen School of Medicine, with the establishment of Qvella following in 2009 and the in-licensing of the tech from UCLA shortly thereafter in 2010.

The test is based on the startup's Field Activated Sample Treatment (FAST) technology, which is a novel method of preparing the pathogen from the blood sample for subsequent amplification. FAST works via a tailored electric field that runs through a sample and releases the intercellular content. The field denatures and inactivates proteins such as nucleases and other contaminants that could inhibit the PCR amplification process, which subsequently occurs in a second chamber.

The process doesn't require traditional extraction and purification methods that use reagents or mechanical processes--or the hours that these can require. All this plays out on an E-Card, which houses all the processes from cell isolation and concentration to the neutralization of enzymes within the cells to reverse transcriptase and PCR amplification to data analysis.

"Qvella is on an accelerated path to significantly change how bacteriology is handled in the healthcare system," summed up Whitecap Partner Blaine Hobson in the announcement.


Bibby Scientific’s Techne PCR-based Method Allows Rapid and Specific Detection of Flavour Spoilage Yeast

Bibby Scientific announced today that it has launched a Techne PCR-based method for reliable and highly specific detection of the yeast, Dekkera bruxellensis, which is a major cause of wine spoilage worldwide, causing large economic losses within the global wine industry.

Flavour-spoiling phenolic compounds released from this yeast lead to undesirable aromas, known as ‘Brett’ taints, that are normally associated with aromas of barnyard, burnt plastic, wet animal and horse-sweat. Detection of the yeast through traditional microbiological techniques can be time-consuming, costly and unreliable. In contrast, real-time or quantitative PCR-based detection methods allow for exceptionally rapid and highly specific identification of the yeast.

Testing for the presence of D. bruxellensis can be determined using the Techne Prime Pro 48 qPCR system in conjunction with the Techne qPCR test ‘Dekkera bruxellensis 26S ribosomal RNA’. The Techne qPCR Kit for D. bruxellensis is designed for the in vitro quantification of D. bruxellensis genomes. The kit is designed to enable the broadest detection possible whilst remaining specific to the D. bruxellensis genome. The kit is comprised of primers and probe sequences that have 100% homology with a wide range of D. bruxellensis sequences based on comprehensive bioinformatics analyses.

Omega Diagnostics Identifies 'Stability Issue' in Long-Awaited HIV Test Kit

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”

Medical diagnostics firm Omega Diagnostics has warned a “stability issue” has slowed progress in commercialising its long-awaited Visitect CD4 HIV testing kit.

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”.

The company had noted in a July update is had brought manufacturing of Visitect CD4 back in-house after reporting “sub-optimal” field trials in Kenya.

The AIM-listed company reported a “manufacturing variability” issue with Visitect CD4 last October which had slowed commercialisation of the product.

Omega notes in a trading update today: “We have recently discovered an ambient temperature effect which manifests as a change in test line signal, with no corresponding change in reference line signal.

“We have identified the step responsible for this temperature effect, and our immediate focus now is to complete the testing needed to determine which component from this step causes it.

“Once the component is identified and replaced or adjusted, the verification and validation process will re-commence.

“We remain confident of resolving this, although the ultimate timing remains uncertain at this stage and we will provide further updates as soon as we can.”

Omega, which recently completed fit-out of a 20,000 sq.ft laboratory and manufacturing space in India as a second manufacturing site for Visitect CD4, said the manufacturing equipment installed is

“generic for most lateral flow rapid tests” and will “provide a low cost manufacturing base for a broader range of infectious disease tests”.

The company said it has selected a range of malaria tests to work on, “as soon as the equipment has completed validation”.

Omega which provides medical diagnostic test kits for allergies, food intolerance and infectious diseases, notes in a trading update it expects revenues will be up eight per cent in the six months to September 30 to £6.15 million for the period, (H1 2014: £ 5.69 million).

On a constant currency basis, Omega expected first half revenues are up 11 per cent.

The company said first half profits are “expected to be similar” to the £0.56 million reported for the first half of last year, as an increase in gross profit has covered a rise in management costs which Omega said is “in line with growth plans”.

Revenues from food intolerance activity are expected to be up 20 per cent to £3.34 million from “significant gains in business throughout the Americas and the Middle East plus a number of markets in Asia and the Far East”.

In infectious disease/other, first half revenues are expected to be up 13 per cent to £1.22 million as a result of growth in the UK and Africa.

Omega said it continues to make “good progress” with its allergy development programme, with a further four allergens optimised in the first half, taking the number of allergens whose performance matches with its IDS-iSYS assay test product to 36.