Wednesday, October 21, 2015

Applied BioCode to Present Poster at AMP on 18-Plex GI Pathogen Panel with a High Throughput System

Applied BioCode announced today that its abstract for a poster on “18-Plex Gastrointestinal Pathogen Detection with a User Friendly, High Throughput System” has been accepted for presentation at the Association for Molecular Pathology meeting, November 5-7 in Austin, TX.

The poster will cover the development progress of Applied BioCode’s new high throughput, multiplex automated MDx system. The new BioCode platform utilizes Applied BioCode’s proprietary Barcoded Magnetic Beads (BMB) and fully automates the process of amplification, target capture and detection for molecular diagnostic assays.

The poster will also provide the latest analytical and performance data for the 18-plex Gastrointestinal Pathogen Panel that is currently in development. The BioCode 18-plex GI Pathogen Panel includes targets for the bacteria (Campylobacter, Clostridium difficile toxin A&B, Salmonella, Shigella, E. coli O157, Enterotoxigenic E. coli, Enteropathogenic E. coli, Shiga toxin producing E. coli, Enteroaggregative E. coli, Vibrio spp., Vibro parahaemolyticus, Vibro Vulnificus, Vibro Cholerae, Yersinia Enterocolitica), viruses (norovirus group I/II, adenovirus 40/41, rotavirus A), and parasites (Giardia, Cryptosporidium, Entamoeba histolytica).

Preliminary data generated for the Gastrointestinal Pathogen Panel with the automated system will be presented by Applied BioCode’s scientific personnel.

MedMira Receives FDA Approval for the Reveal® G4 Rapid HIV-1 Antibody Test

MedMira Inc. has received approval from the U.S. Food and Drug Administration (FDA) for the next generation of the Company's rapid HIV test, Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4). Reveal G4 adds new capabilities in testing fingerstick and venipuncture whole blood specimens which extends the Reveal product line into point-of-care settings and new market segments within the U.S. healthcare market.

With the approval of Reveal G4, MedMira is poised to capitalize on the rising demand for point-of-care whole blood HIV testing in the U.S., where today more than 1.2 million people are living with HIV, and as many as 168,000 remain unaware of their infection. Built on the motto of helping people know…®, MedMira has been employing its patented Rapid Vertical Flow Technology to deliver fast, accurate, high quality rapid HIV tests to healthcare providers and their patients in the U.S. since 2003, when the first generation of the Reveal rapid HIV test received FDA approval. With an initial focus on laboratories and hospitals where most of the HIV testing uses serum and plasma specimens, MedMira now moves to the front lines of healthcare with Reveal G4. Rapid tests are routinely being conducted in community based, point-of-care settings, where accessibility and convenience encourage more people to get tested during regular medical check-ups.

"With this FDA approval of Reveal G4, we are bringing the latest advancements in our Rapid Vertical Flow Technology platform to our U.S. customers. Reveal G4 delivers the same speed, performance, and quality that customers have come to know as hallmarks of our technology platform, and now we've added whole blood applications. This product is all about creating a rapid HIV testing solution that gives healthcare providers and their patients choices that make testing possible in any setting," said Hermes Chan, CEO, MedMira Inc. "Reveal G4 will make a significant contribution to increasing cost-effective, patient-focused HIV testing at the point-of-care, while continuing to serve the needs of our customers in laboratories and hospitals."

Reveal G4, like all MedMira tests, is built on the Company's patented Rapid Vertical Flow Technology platform which offers unique advantages unmatched by competitors. Users can obtain instant results from a Reveal G4 test following a simple 3-step testing procedure; add the specimen, process with the InstantGold™ cap, and read the results. This enables counselling, and if needed, initial treatment, to be delivered in a single patient visit. The streamlined testing approach and instant results that Reveal G4 facilitates translates to higher patient throughput for clinics and a reduction in the number of patients who are lost to follow-up, never returning for their results. As healthcare providers look for cost-efficient ways to integrate routine HIV testing in their practices and programs, a tool like Reveal G4 offers the speed and quality which will be critical to success.

In addition to its Reveal G4 test, MedMira is developing a broad range of rapid tests for major infectious diseases, as it continues to capitalize on the capabilities of its proprietary Rapid Vertical Flow Technology platform to create multiplex rapid tests that diagnose multiple infections on a single test with a single drop of specimen.

Roche Gets FDA Approval for Cobas MDx Systems; HBV, HCV Viral Load Tests

Roche has received approval from the US Food and Drug Administration for its Cobas 6800 and Cobas 8800 molecular diagnostic platforms and associated hepatitis B and hepatitis C viral load assays.

The assays are the first approved by the FDA for use on the Cobas 6800 and 8800. These medium- and high-throughput PCR systems were unveiled in 2013, and allow for rapid, automated, mixed-batch processing.

Cobas HBV, a real-time PCR test for HBV genotypes A through H, was CE-marked in May. The Cobas HCV assay employs the firm's dual-probe approach to detect hepatitis C RNA and was CE-marked last December.

Roche noted in a statement that it currently has viral load tests under FDA review for HIV-1 and cytomegalovirus. When approved, these will complete a portfolio of viral load monitoring for the Cobas 6800/8800 systems, with further menu expansion plans including qualitative tests for donor screening, women's health, and microbiology.

Ugandan Scientist Develops 5 Minute Ebola Test Kit

Ugandan scientist, Dr Misaki Wayengera has developed a rapid diagnostic test that can detect Ebola proteins in less than five minutes at the point of care in the community, a giant step in African medical innovation and in the fight against Ebola.

However, the process of developing the test kit has been marred by funding challenges and bureaucratic setbacks which threatened to derail the project.

According to New Times, Dr Wayengera did not receive financial support from the government although at the time, “the president’s office acknowledged the importance of his research for biodefence and pledged full support”.

Through Dr Wayengera’s efforts, his research team at Makerere University College of Health Sciences eventually secured funding from Grand Challenges Canada, a non-profit initiative funded by the Canadian government.

The team initially received $100,000 Canadian dollars (US$95,600) grant from the organisation before being offered a further $1.5 million by Grand Challenges Canada.

Dr Wayengera’s invention, “is the first rapid diagnostic test that is able to detect various strains of the Ebola and Marburg viruses.”

The inventor is reportedly to have applied for a patent with the African Regional Intellectual Property Organisation and the World Intellectual Property Organisation in 2013 and 2014.

“On average it takes about one year for a patent to be awarded by the World Intellectual Property Organisation and five years for it to be awarded by the African Regional Intellectual Property Organisation,” New Times reported.

The breakthrough is expected to reduce the Ebola death rate through quicker diagnosis of the diseases.

Rapid Micro Biosystems Announces the Commercial Availability of the Growth Direct System for Sterility Testing

Rapid Micro Biosystems, the provider of automated, rapid, non-destructive detection and enumeration technologies in microbiology, today announced the launch of the sterility testing application for the Growth Direct(TM) System. The Growth Direct System automates the incubation, detection, and reporting steps for pharmaceutical quality control laboratories. The sterility test mirrors the compendial method sterility test, supporting both aerobic and anaerobic test conditions. Sterility testing joins the other application supported by the Growth Direct System, including environmental monitoring and bioburden testing. The technology is based on the detection of the natural auto-fluorescence of microorganisms, and can detect growing colonies in about half the time of the traditional 14-day sterility test, providing a significant time savings.

Developed in part with funds from the Biomedical Advanced Research and Development Authority (BARDA) as part of BARDA's Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development program, the Growth Direct System for Sterility Testing revolutionizes pharmaceutical microbial quality control testing while adhering to the stringent regulatory requirements of the sterility test.

"BARDA has been a strong partner in the development of this technology," said Julie Sperry, Vice President of Marketing, Product Management and Services at Rapid Micro Biosystems. "Having the support of the Department of Health and Human Services indicates how critical a rapid sterility test is to both manufacturers and the regulatory community."

The technology supports testing of filterable samples and is designed for high and low volume sterility testing environments.

  • Positive Results Starting in Hours:  The test provides early detection of a positive microbial contamination allowing faster response to contamination events.
  • 7 Days Versus 14:  Final results of the sterility test are available in half the time of the traditional test.
  • Discrete Colonies:  Growth occurs on the surface of a membrane and colonies can be "picked" directly, eliminating the time and labor necessary with a subculture step
  • Closed Loop:  Sample preparation is closed looped and performed in an isolator or in a clean room, similar to the existing method.  The test replicates both anaerobic and aerobic test conditions.
  • Non-Destructive:  No additional reagents are added. Samples with positive results can continue to grow.
  • Complete Audit Trail:  A complete history of user activity as well as sample processing are available, ensuring compliance with 21 CFR Part 11.

"Saving manufacturers 7 days of sterility testing time delivers a significant financial benefit by accelerating product manufacturing and final product release," states Wendy Hinchey, Vice President of Sales. "Demand for the solution to this time consuming test has been very strong, as companies realize the resulting value the system provides their organizations."

"The release of our sterility application represents a significant milestone in Rapid Micro Biosystems' goal to automate key microbial tests in the manufacturing quality control lab," said Robert Spignesi, President and CEO of Rapid Micro Biosystems. "Our rapid sterility application, along with our environmental monitoring and bioburden applications, offers quality control labs options to improve productivity and streamline testing while closely aligning to traditional methods."

Hema Diagnostic Systems Announces the Final Validation Process for a New Rapid Anthrax Ab Test

Hema Diagnostic Systems, LLC, a US based medical device company, announced today in Miramar, Florida, the final evaluation phase of its' new rapid, whole blood/serum tests, officially designated as the Rapid 1-2-3 Hema(R) Express(R) Anthrax Ab test.

According to Lawrence Salvo, President and CEO of Hema Diagnostic Systems, "The development and completion of the new Rapid 1-2-3 Hema Express Anthrax Ab diagnostic will make available, the very first rapid Anthrax Ab whole blood test that can deliver accurate, reliable and repeatable testing for the anthrax toxins of PA and LF, in the field and with a very high degree of sensitivity and specificity. Test results are read in 15 minutes from the start of the test process… the diagnostic can also be used with serum for laboratory processes." Additionally, Salvo said: "With the potential funding and partnership that HDS anticipates from Generex Biotechnology Corporation, we see a substantial opportunity to expand the commercialization of this product, especially here in the United States. Other current HDS products as well as those future devices presently in various stages of research and development, will also benefit from this growing relationship."

The new and novel Rapid 1-2-3 Hema Express Anthrax Ab has been developed to detect and differentiate the Anthrax Toxins of Protective Antigen (PA) and the Lethal Factor (LF) through either whole blood from a finger stick and capable of being performed in a clinic or in-field, as well as the use of serum in a laboratory procedure. Separate and individual Test ("T1 and T2") lines have been assigned to each of the two Anthrax Toxins for separate and individual confirmation of the presence of either/or, or both. Additionally, a Control ("C") line has been added on the test strip to confirm to the user that once the test process has started, the test is operational.

Sensitivity and specificity has been determined using existing in-house Quality Control ELISA panels. Following multiple test and batch evaluations, sensitivity was determined to be 100% and specificity at 99.6%. The device delivered continuing high performance, with significant repeatability.

Storage is set at 2°C-30°C with an initial designated shelf life of 18 months, and with the intention to increase shelf life as additional stability testing progresses over the next many months. Additional testing is being undertaken on a Real Time and Accelerated Stability basis, at higher temperatures.

The Rapid 1-2-3 Hema Express Anthrax Ab will be offered in the easy-to-use Rapid 1-2-3 Hema Express(R) housing which has been designed to be user-friendly and which reduces the opportunity of cross-infection through user-error and/or improper control of the potentially positive whole blood/serum sample.

Based upon the current timeline, it is anticipated that initial regulatory processes will be completed by January 2016.

FDA Signs Off on BioFire Diagnostics' Rapid Meningitis Test

BioMérieux's BioFire Diagnostics got an FDA OK for its rapid meningitis and encephalitis test, a feather in the company's cap as it diversifies its portfolio and ramps up business in an increasingly competitive market.

The agency cleared BioFire's FilmArray ME panel through its de novo classification process, which it reserves for low- to moderate-risk devices with no market precedent. Regulators based their decision on three studies including one with 1,560 patients suspected of having meningitis and encephalitis, which found that FilmArray performed as well as traditional testing methods to pinpoint the infections.

BioFire's test could offer an advantage over current screening methods, which sometimes take as many as three days to deliver results. Testing for CNS viral infections is even more complicated, the agency said, as many hospitals have to ship specimens and tests to labs for processing. The nucleic acid-based panel screens for 14 bacterial, viral and yeast pathogens that cause central nervous system (CNS) infections by using a small sample of spinal fluid, providing results in about an hour, the FDA said in a statement.

"Testing one sample for many pathogens and potentially having test results sooner should allow physicians to use this information, along with other clinical findings and test results, to provide improved diagnosis and treatment for these very serious illnesses," Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's Center for Devices and Radiological Health, said in a statement.

But FilmArray ME is not a completely surefire way of screening for CNS infections. The test does not pinpoint all causes of the infections or give information about which drugs would work best at treating bacterial infections, the FDA pointed out. The agency is recommending that doctors still carry out bacterial and fungal cultures of spinal fluid along with FilmArray to reduce false negative and false positive results.

The FDA blessing marks a victory for BioFire, which has been working hard to chalk up regulatory wins since selling out to BioMérieux last year for $450 million plus debt. In May 2014, the company nabbed an FDA OK for its innovative GI panel. Months later, the company scored the FDA's emergency authorization for two of its rapid Ebola tests amid the global outbreak.

Great Basin Scientific Submitted Shiga Toxin Direct Test to FDA for 510(k) Clearance

Great Basin Scientific, Inc., a molecular diagnostics company, announced today that the Company has submitted its Shiga Toxin Direct Test to the U.S. Food & Drug Administration (FDA) for 510(k) clearance following the successful completion of a clinical trial that met all of Great Basin’s clinical objectives. Upon clearance, the test will be the only stand-alone molecular test to detect Shiga toxin-producing E. coli and the serotype O157 directly from a patient specimen.

The Centers for Disease Control (CDC) reports STEC is a leading cause of bacterial enteric infections in the U.S., and in 2009, issued a recommendation that all stools submitted for testing from patients with acute community-acquired diarrhea should be cultured for STEC O157. These stools should be simultaneously assayed for non-O157 STEC with a test that detects Shiga toxins or the genes encoding these toxins. Conventional laboratory culture-based testing for STEC can be laborious and time-consuming, taking 48-96 hours to prepare and process the tests. The CDC states that prompt, accurate diagnosis of a STEC infection is imperative to reduce further infection or kidney damage, and to determine the best course of care, as antibiotic therapy in patients with STEC infections might result in more severe disease.

Believed by Great Basin to be superior to alternative tests on the market, the Company’s Shiga Toxin Direct Test offers true sample-to-result testing with less than three minutes of hands-on time, no specimen enrichment step, and presents much higher sensitivity than either non-molecular or antigen-based rapid tests, thereby simplifying workflow for laboratory technicians and providing cost savings while facilitating better patient care. The Shiga Toxin Direct Test quickly detects Shiga toxin-producingE. coli – specifically stx1 and stx2 genes – in addition to identifying the serotype O157. E. coli O157 can lead to a life-threatening condition called hemolytic uremic syndrome (HUS), characterized by hemolytic anemia and renal failure. By including identification of O157 in the test, a laboratory can avoid running additional tests or expensive panels to get the definitive answers clinicians need for timely and accurate course of care, providing the means to avoid health complications that may result from misdiagnosis.

“We are aggressively driving the development and commercialization of assays that provide small-to-medium size hospitals and labs with the easiest-to-use and most cost-effective molecular diagnostic platform available,” said Ryan Ashton, co-founder and Chief Executive Officer of Great Basin Scientific. “We remain focused on expanding our menu, and we believe submitting our Shiga Toxin Direct Test for 510(k) – with breakthrough workflow and more answers than other stand-alone tests – is representative of our dedication to meet the market’s demand for simpler methods and a better overall solution to infectious disease diagnostics,” Mr. Ashton continued.

Once approved and commercially available, the Shiga Toxin Direct Test can be run on the same Great Basin analyzer used to perform Great Basin’s commercially available low-plex tests forClostridium difficile (C. diff) and Group B Streptococcus (GBS), and their multi-plex Staph ID/R Blood Culture panel currently in review by the FDA.

Tuesday, October 13, 2015

Miacom Diagnostics GmbH Announces Issuance of a Patent for Innovative in vitro Diagnostic Probes

Miacom Diagnostics GmbH, Duesseldorf, a company focused on the development and production of medical tests for the detection of acute infectious diseases, today announced the U.S. Patent and Trademark Office has issued a patent for their innovative DNA probes.

The official U.S. patent, named “Nucleic acid beacons for in situ fluorescence hybridization and chip technologies,” encompasses a concept for the development and use of new DNA probes for in vitro diagnostics and paves the way for the establishment of novel, rapid and convenient pathogen detection procedures in the U.S. market. The patent has already been granted in other regions including Europe, Japan, Hong Kong and Australia.

This patent provides Miacom with extensive protection of their unique probe design and its application in providing pathogen detection by means of multiplex FISH assays.

Miacom’s technology enables identification of a multitude of pathogens by means of molecular beacons. The design of these probes eliminates the extremely laborious and error prone washing steps which often cause significant problems in traditional FISH. This new technology also increases probe sensitivity and specificity to unprecedented levels.

“We are excited about the issuance of the fundamental patent for applying our technology to molecular diagnostics applications. Research teams all over the globe have worked for decades on this idea. The miacom team has made this method available for routine multiplex testing directly from patient samples and the granted U.S. patent strengthens our position in one of the key markets in the world,” said Dr. Walter Freiherr von Stein, Chief Scientific Officer of Miacom Diagnostics GmbH. “We have now laid the foundations for delivering a wide variety of applications and for enabling ultra fast FISH in new routine IVD detection scenarios.”

“The award of this patent by the U.S. Patent and Trademark Office further strengthens our position in in vitro diagnostics as it not only covers probe design but also their application. With the upcoming commercialization of our first FDA cleared product, it comes at an exciting time at Miacom,” said Dr. Mirko Stange, Chief Executive Officer of Miacom Diagnostics GmbH. “This success accelerates the next steps in pursuing new development opportunities with existing patent protection. This is another important milestone in Miacom’s corporate development.”

Miacom also holds additional patents in these fields including ID/AST and resistance detection, as well as reagents for respiratory sample preparation that are either currently being developed or already available on the market. Using its broad patent portfolio, Miacom is dedicated to advancing rapid microbial diagnostics and resistance screening with extraordinary dynamics.

Thursday, October 08, 2015

Researchers Develop Rapid Method for Water, Soil Pathogen Screening

Researchers at Ben-Gurion University of the Negev (BGU) and the Massachusetts Institute of Technology (MIT) have developed a highly sensitive, cost-effective technology for rapid bacterial pathogen screening of air, soil, water, and agricultural produce in as little as 24 hours.

According to Ezra Orlofsky Ph.D, who led the research while working on his doctorate at the BGU Zuckerberg Institute for Water Research, "Rapid and reliable pathogen detection in field samples is critical for public health, security and environmental monitoring. Current methods used in food, water or clinical applications rely on labor and time-intensive culturing techniques while activities such as dairy farming, wastewater and runoff treatment necessitates real-time monitoring of pathogens in environment samples."

The study, published online in the Water, Air & Soil Pollution journal (Springer) defines an accurate, inexpensive, high-throughput, and rapid alternative for screening of pathogens from various environmental samples. "This is the first study to comprehensively assess pathogen concentrations in such a broad variety of environmental sample types while achieving multiple pathogen detection with complete parallel testing by standard (or traditional) methods," Orlofsky explains.

"We accurately identified Salmonella (S. enterica) in environmental soil samples within 24 hours, while traditional methods take four to five days and require sorting," Orlofsky says. "We also successfully identified a sometimes-fatal infection, Pseudomonas aeruginosa, in aerosols generated by a domestic wastewater treatment system. The results suggest that the developed method presents a broad approach for the rapid, efficient and reliable detection of relatively low densities of pathogenic organisms in challenging environmental samples."

To evaluate the technology, a variety of environmental samples, including aerosols, various soil types, wastewater and vegetable surface (tomato), was concurrently spiked with Salmonella enterica and/or Pseudomonas aeruginosa. The researchers chose these pathogens because they are leading causes of illness, have high survival potential in the environment and are considered difficult to detect accurately at low concentration.

"When applied to non-spiked field samples, our method outperformed the standard methods substantially, while detecting pathogens within a day of receiving the samples," says Orlofsky. "Since this focused and economical screening procedure tells us exactly where to look within a day, we don't need to monitor hundreds of samples and sub-samples over several days."

The two techniques used concomitantly are an evolved "MPN-type enrichment" ("Most Probable Number") used in microbiology testing, coupled with "qPCR," (quantitative polymerase chain reaction) widely used in molecular biology to monitor the amplification of DNA in real time.

"We considerably shortened previous protocols, do not use any name-brand expensive re-agents for DNA extraction and purification, and increased the procedure and workflow to segue easily from raw sample to qPCR assays," says Orlofsky.

While detection in soil, water and vegetable samples was highly sensitive (as low as one cell per test), the researchers believe additional steps are required to further improve the detection levels such that they reflect low pathogen concentrations (especially ones with low infective doses) in aerosols.

The researchers recommend applying this method in the future to other pathogens such as Legionella pneumophilia, (Legionnaire's Disease), Staphylococcus aureus (Staph infection) and Campylobacter jejuni, the second most common cause of foodborne illness.


Rapid Tuberculosis Test in Development

In a new study, scientists have described the accuracy of three new rapid tests designed to detect drug-resistant forms of tuberculosis.

With the recent series of experiments, scientists based at the University of California, San Diego School of Medicine, collected sputum samples from 1,128 study participants. Each of the samples was examined using the three different tests. Two of the tests used advanced molecular techniques. These methods looked for genetic mutations in the bacterium’s DNA that confer resistance to antibiotics.

The third test was very different. This was a low-cost and straightforward version of a standard bacterial culture technique. Such a method is regarded as "low tech" in the world of rapid and alternative microbiological methods.

Tuberculosis is one of the most widespread bacterial diseases on the planet. It is an infection that has plagued humans for over millennia. As I’ve written elsewhere: “Tuberculosis is a widespread infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. The symptoms of infection consist of a chronic cough with blood-tinged sputum, fever, night sweats, and weight loss. Tuberculosis is closely linked to both overcrowding and malnutrition.”

With the collected data, the results were compared to a reference standard technique for detecting resistance to seven of the main anti-tuberculosis drugs. It was found that each of the three rapid assays accurately identified resistance to first- and second-line oral antibiotic treatments.

Furthermore, while the results were less accurate, each of tests was effective in detecting resistance to injectable antibiotics (amikacin and capreomycin) administered in cases of multi-drug resistance tuberculosis.

None of the tests fared well in detecting resistance to one drug, the injectable antibiotic kanamycin, which is also used to treat multi-drug resistant tuberculosis.

Despite similarities in accuracy, the rapid tests were, in fact, very "rapid." The molecular techniques gave a result in a little over one day; the culture method took 14 days, and the reference standard test took almost 25 days to deliver a result.

The research findings are described in the journal PLOS ONE. The paper is called “Performance Comparison of Three Rapid Tests for the Diagnosis of Drug-Resistant Tuberculosis.”

New On-Chip Optical Sensing Technique Used to Detect Multiple Flu Strains

New chip-based optical sensing technologies developed by researchers at UC Santa Cruz and Brigham Young University enable the rapid detection and identification of multiple biomarkers. In a paper published October 5 in Proceedings of the National Academy of Sciences, researchers describe a novel method to perform diagnostic assays for multiple strains of flu virus on a small, dedicated chip.

"A standard flu test checks for about ten different flu strains, so it's important to have an assay that can look at ten to 15 things at once. We showed a completely new way to do that on an optofluidic chip," said senior author Holger Schmidt, the Kapany Professor of Optoelectronics in the Baskin School of Engineering at UC Santa Cruz.

A schematic view shows the optical waveguide intersecting a fluidic microchannel containing target particles. Targets are optically excited as they flow past well-defined excitation spots created by multi-mode interference; fluorescence is collected by the liquid-core waveguide channel and routed into solid-core waveguides (red). Credit: Ozcelik et al., PNAS 2015

Over the past decade, Schmidt and his collaborators at BYU have developed chip-based technology to optically detect single molecules without the need for high-end laboratory equipment. Diagnostic instruments based on their optofluidic chips could provide a rapid, low-cost, and portable option for identifying specific disease-related molecules or virus particles.

In the new study, Schmidt demonstrated a novel application of a principle called wavelength division multiplexing, which is widely used in fiber-optic communications. By superimposing multiple wavelengths of light in an optical waveguide on a chip, he was able to create wavelength-dependent spot patterns in an intersecting fluidic channel. Virus particles labeled with fluorescent markers give distinctive signals as they pass through the fluidic channel depending on which wavelength of light the markers absorb.

"Each color of light produces a different spot pattern in the channel, so if the virus particle is labeled to respond to blue light, for example, it will light up nine times as it goes through the channel, if it's labeled for red it lights up seven times, and so on," Schmidt explained.

The researchers tested the device using three different influenza subtypes labeled with different fluorescent markers. Initially, each strain of the virus was labeled with a single dye color, and three wavelengths of light were used to detect them in a mixed sample. In a second test, one strain was labeled with a combination of the colors used to label the other two strains. Again, the detector could distinguish among the viruses based on the distinctive signals from each combination of markers. This combinatorial approach is important because it increases the number of different targets that can be detected with a given number of wavelengths of light.

For these tests, each viral subtype was separately labeled with fluorescent dye. For an actual diagnostic assay, fluorescently labeled antibodies could be used to selectively attach distinctive fluorescent markers to different strains of the flu virus.

While previous studies have shown the sensitivity of Schmidt's optofluidic chips for detection of single molecules or particles, the demonstration of multiplexing adds another important feature for on-chip bioanalysis. Compact instruments based on the chip could provide a versatile tool for diagnostic assays targeting a variety of biological particles and molecular markers.

The optofluidic chip was fabricated by Schmidt's collaborators at Brigham Young University led by Aaron Hawkins. The joint first authors of the PNAS paper are Damla Ozcelik and Joshua Parks, both graduate students in Schmidt's lab at UC Santa Cruz. Other coauthors include Hong Cai and Joseph Parks at UC Santa Cruz and Thomas Wall and Matthew Stott at BYU.

In another recent paper, published September 25 in Nature Scientific Reports, Schmidt's team reported the development of a hybrid device that integrates an optofluidic chip for virus detection with a microfluidic chip for sample preparation.

"These two papers represent important milestones for us. Our goal has always been to use this technology to analyze clinically relevant samples, and now we are doing it," Schmidt said.


OraSure Technologies Provides Update on OraQuick Ebola Rapid Antigen Test Business

OraSure Technologies, Inc., a leader in point of care diagnostic tests and specimen collection devices, announced that it has made significant progress regarding the commercialization of its OraQuick® Ebola Rapid Antigen Test.

The Company announced that the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) has exercised an option to provide $7.2 million in additional funding for the Company's OraQuick® Ebola Rapid Antigen Test. This funding will be used primarily for clinical and regulatory activities required to request U.S. Food and Drug Administration (FDA) 510(k) clearance for this product. This option is part of the $10.4 million funding contract (base plus options) between OraSure and BARDA that was previously announced in June 2015.

The Company also announced today that HHS' Centers for Disease Control and Prevention (CDC) will purchase approximately $1.5 million of the Company's OraQuick® Ebola Rapid Antigen Test. The CDC purchase is expected to be fulfilled by the end of 2015. CDC is purchasing the OraQuick® Ebola Rapid Antigen Tests for field testing in West Africa. This is the second such purchase of this product for field testing made by CDC.

"The populations affected by Ebola are large, and current testing methods severely limit testing capacity. As such, we believe that the OraQuick® Rapid Ebola Test will be an important tool in containing and controlling the Ebola outbreak," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "We are grateful to both the CDC and BARDA for their continued support."

The OraQuick® Ebola Rapid Antigen Test utilizes the same proven technology platform used in the Company's rapid HIV and HCV test kits. The OraQuick® Ebola Test received Emergency Use Authorization (EUA) from the FDA in July 2015 and is designed to detect viral antigens in fingerstick and venous whole blood from patients presenting with signs and symptoms of Ebola infection in conjunction with epidemiological risk factors. Positive (reactive) results may be read as soon as they appear and have been observed as early as 4 minutes. Negative (non-reactive) results have to be read at 30 minutes. The test can be used at ambient temperatures (up to 40°C / 104°F), is easy to use with a simple visual read, and does not require instrumentation.

This project has been funded in whole or in part with Federal funds from BARDA, part of the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; under Contract No. HHSO100201500009C.

Critical reagents in the OraQuick® Ebola Rapid Antigen Test are being supplied by the Viral Hemorrhagic Fever Consortium (VHFC; and the Biological Defense Research Directorate at the United States Navy Medical Research Center (NMRC). The VHFC reagents were developed with the support of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health ("NIH/NIAID"). VHFC members, Autoimmune Technologies LLC, and Zalgen Labs LLC manufacture the critical reagents.

Portable, Rapid DNA Test Can Detect Ebola and Other Pathogens

Using technical advances not yet developed when the 2014 Ebola outbreak began, UC San Francisco-led scientists completed a proof-of-principle study on a real-time blood test based on DNA sequencing that can be used to rapidly diagnose Ebola and other acute infections. The researchers said that the test can be used even where lab space and medical infrastructure are scarce. Charles Chiu, MD, PhD, associate professor of laboratory medicine at UCSF, led a team that detected the genetic fingerprints of Ebola in stored blood samples from two African patients who had acute hemorrhagic fever, completing the diagnosis within five hours of opening the samples--the DNA sequencing itself took just 10 minutes.

Most commercially available or research-based genetic diagnostic tests target specific pathogens. But Chiu and UCSF colleagues have pioneered techniques that do not require suspected pathogens to be identified beforehand in order to detect their unique genetic fingerprints. This unbiased approach of analyzing all DNA in a clinical sample without knowing which species are present, which was used in the Ebola detection, is called "metagenomic" analysis.

To obtain such quick results the researchers developed new analysis and visualization software and used it on a laptop computer to leverage an emerging DNA-sequencing technology known as nanopore sequencing.

In the same set of experiments, published online in Genome Medicine on September 28, the researchers were able to detect Chikungunya virus, from a Puerto Rican outbreak, just as quickly in a blood sample from a donor with no symptoms, but who eventually reported having fever and joint pains. In another example of the technique's power, detection of hepatitis C virus in blood from an infected UCSF patient, present at a much lower concentration than the other viruses, took just 40 minutes from the start of sequencing.

"This point-of-care genomic technology will be particularly attractive in the developing world, where critical resources, including reliable electric power, laboratory space, and computational server capacity, are often severely limited," Chiu said.

Many companies are developing nanopore technology, which distinguishes individual nucleic acids by the distinctive perturbations they create in electric currents as they individually pass through microscopic pores. Chiu's lab group was one of the first to pay $1,000 for access to an experimental DNA nanopore sequencer made by Oxford Nanopore Technologies, called the MinION. The device is small enough to fit in the palm of the hand and is powered by a USB connection to a laptop.

Last year, using a similar metagenomic approach to pathogen detection, Chiu teamed up with UCSF colleagues to solve a medical mystery that was highlighted in a New England Journal of Medicine case study. The researchers used their software and another DNA-sequencing technology to analyze all DNA in a spinal fluid sample, leading to the diagnosis of an unusual but treatable bacterial cause of encephalitis in a critically ill Wisconsin boy whose health had been worsening for months.

That earlier analysis took two days. The detection of Ebola in the new study was more rapid because nanopore sequencing yields data immediately and in real time, unlike the technology used in the Wisconsin case, which takes much longer to provide data for analysis.

Nanopore technology is new and still error-prone, Chiu said, but speed and accuracy are improving at a quick pace. With the time required for DNA sequencing, analysis and reporting now cut down to minutes, Chiu has set his sights on streamlining and automating the sample preparation step, which still requires several hours, for use in both clinical laboratory and field settings.

"To our knowledge, this is the first time that nanopore sequencing has been used for real-time metagenomic detection of pathogens in complex clinical samples in the setting of human infections," Chiu said. "Unbiased point-of-care testing for pathogens by rapid metagenomic sequencing has the potential to radically transform infectious disease diagnosis in both clinical and public health settings."

Collaboration Achieves Major Pathogen Detection Milestone Saving Lives - Reducing Costs

Swiss based Hutman Diagnostics AG together with its Canadian partner Axela Inc. have reached a significant goal in their nucleic acid based infectious disease detection program referred to as Alena Diagnostics. Together they successfully demonstrated multiplex detection of pathogens in a new, low cost cartridge format at levels of sensitivity, specificity and inclusivity necessary for commercial success.

For this study, infected clinical samples were obtained from Hutman's network of microbiology laboratory partners in the Czech Republic, Germany, United Kingdom and Switzerland. Previously, rapid and sensitive detection of pathogens had been demonstrated using Axela's bench top Ziplex platform.  This instrument uses proprietary flow though arrays in a TipChip format to efficiently hybridize and detect over 100 targets simultaneously.  These new samples were tested in parallel on Ziplex and prototype next generation cartridge systems from Axela.  Flow though arrays in both cases were designed using probes against novel bacterial targets derived from Hutman's internal development process. The new platform provided equal or superior results to the laboratory system but in a simple, cartridge format suitable for Point of Use applications. Having demonstrated this technical performance, Alena is now targeting initial product commercialization within 15-18 months.

The Alena value proposition is compelling whether compared to existing culture based or competitive nucleic acid detection systems. The Alena platform will be capable of multiplexing in excess of 100 pathogens on a single chip (see picture), including bacterial resistances to antibiotics and providing sample to answer results while the patient is still undergoing initial evaluation. Novel fluidics facilitate full automation in an inexpensive to manufacture consumable. The low capital cost of the instruments will allow Alena products to compete in broad infectious disease markets.
Initial applications include endocarditis, bone and joint infections, abscesses, meningitis and sepsis, as well as the detection of the most prevalent antibiotic resistances. The platform's potential to provide rapid and cost effective pathogen screening in a near patient environment will represent a breakthrough in clinical protocols and patient outcome…. saving lives and reducing costs.

Montreal Scientists Score Possible Breakthrough for Rapid Diagnostic Medical Tests

A simple and fast chemical process developed by scientists in Montreal could allow family doctors to one day use equipment as straightforward and cheap as a diabetic's blood sugar tests to diagnose a range of diseases in minutes from their offices, instead of waiting days for results to come back from a lab.

In a Journal of the American Chemical Society publication, researchers from the University of Montreal describe a novel way to detect large molecules like antibodies in blood using a quick, one-step process involving electricity and DNA.

The technique could give rise to a proliferation of new so-called point-of-care medical tests — blood tests that can be performed in the field, possibly even by patients themselves, and that yield results in minutes.

"Nowadays if you go see a physician to have a blood test, they'll send you to a clinic. A couple vials of blood will have to be analyzed by a technician with specialized techniques, and the results will only come back a week later," said paper co-author Alexis Vallée-Belisle, a University of Montreal chemistry professor and the Canada Research Chair in bioengineering and bio-nanotechnology.

"What these tests are looking for is antibodies — proteins that are generated by the body in response to viruses or bacteria. The highlight of the technique we developed is you put a drop of blood on our electrodes, and in five or 10 minutes you can know if you have the antibody. And in principle, you can detect any antibody you want."

Electrical Current

Vallée-Belisle and his team, working with a chemist from the University of Rome, came up with a way to detect antibodies by having them bind to loose, single strands of DNA. Those single strands then attempt to pair up with nearby complementary strands to form the characteristic DNA double helix.

The researchers designed the single DNA strands so that if no antibodies are present when they bind with their complementary pairs, a detectable electrical current flows. But if antibodies are present and attached to the loose strands, the current drops. The drop is so precisely measurable that the test can even be used to determine how much antibody is in a sample, instead of simply indicating its presence or absence.

They call the process "electrochemical steric-hindrance hybridization assay," or eSHHA, because it takes advantage of how the DNA molecules react in the presence of other larger particles, an effect known as "steric hindrance."

Biochemistry professor Kevin Plaxco of the University of California at Santa Barbara, who supervised Vallée-Belisle's previous postdoctoral work and who is himself an expert in electrochemical methods to detect antibodies, called the results "clever" and "very simple and elegant."

"They're detecting the molecules in a way that has some rather interesting advantages," he said Thursday.

There are currently point-of-care antibody tests on the market for diagnosing HIV within minutes, Plaxco pointed out, but they give qualitative yes-or-no results and not nuanced, quantifiable data on how much antibody was found.

That might not be needed for HIV, but it could be useful for doctors treating autoimmune diseases, or for using the eSHHA technique to detect things like how much of a chemotherapy drug a patient is metabolizing so that their dose can be fine-tuned.

STD Screening in Minutes

The Montreal researchers' method would also allow for simultaneous testing for the presence of more than a dozen different antibodies, meaning one small drop of blood and one quick test would be enough to screen for almost every sexually transmitted disease within minutes, at a doctor's office.

The doctor could then immediately notify the patient and prescribe medication right away if any of the results came back positive.

"Currently a large percentage of people don't come back to see the results, because you need to take another appointment, so you waste a lot of time and a lot of money," Vallée-Bellisle said.

He said so far, his team has shown their method works to detect five different typical "model" proteins and will soon publish research showing they can also detect three of the various HIV antibodies. After that, they're also aiming to detect antibodies for syphilis and herpes.

One of the big advantages of their method is its cost: The electrodes used to detect the electrical current can be had for five to 10 cents each, and creating the necessary DNA sequences can be as cheap as $10 for a large enough strand to run "thousands of tests," Vallée-Bellisle said.

"The basic infrastructure for all this is dirt cheap," Plaxco confirmed.

Vallée-Bellisle said the next step in commercializing their findings will be signing up a business partner to work on developing the right niche for their work.

BD MAX™ Enteric Parasite Panel Receives FDA Clearance for Detection of Common and Pathogenic Intestinal Parasites

BD Life Sciences, a segment of global medical technology company BD (Becton, Dickinson and Company) announced the availability of the U.S. Food and Drug Administration (FDA) cleared BD MAX™ Enteric Parasite Panel for use on the BD MAX System.

The BD MAX Enteric Parasite Panel is the latest panel in the BD MAX Enteric suite of assays that aid in the diagnosis of infectious gastroenteritis. This panel joins the BD MAX Enteric Bacterial Panel detecting the pathogens that are responsible for up to 95 percent of the bacteria causing gastroenteritis.i  With the availability of the BD MAX Enteric Parasite Panel, the majority of pathogens causing this disease can be detected with a fully automated, rapid and accurate platform.

The BD MAX Enteric Parasite Panel is a qualitative IVD test detecting DNA from Giardia lamblia, Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica in both unpreserved and 10 percent formalin-fixed stool specimens.

"What we see as the value it will bring to us is the speed with which we can accurately provide patient results," said Kate Buehler, molecular specialist at Aspirus Wausau Hospital Reference Laboratory. "Coupled with the BD MAX Enteric Bacterial panel, it allows us to provide a flexible diagnostic solution with ease."

Doug White, vice president and general manager, Molecular Diagnostics & Women's Health, BD Life Sciences said, "We continue to expand the BD MAX System menu of unique, clinically relevant panels. BD's suite of enteric assays will allow flexibility for specific testing needs based on patient and clinical presentation, enabling more efficient patient management and laboratory processes."

Globally, there are approximately 1.7 billion cases of diarrhea accounting for more than 2 million deaths annually.  Children less than 5 years of age are particularly at risk with around 760,000 deaths each year.ii These infections may be caused by viruses, bacteria or parasites and often take two to three days or more to identify in the clinical laboratory using conventional methods. Infections caused by the parasites Giardia and Cryptosporidia, while relatively common, may be subject to under-diagnosis and reporting in the US.iii

"The BD MAX assays for Clostridium difficile (C. diff) and selected enteric bacterial and parasitic pathogens are the first commercial assays for selective, targeted diagnosis of enteric infectious diseases, an approach that is consistent with the recommendations of the American Society of Microbiology and the Infectious Disease Society of America," said Patrick Murray, Ph.D., senior director of Worldwide Scientific Affairs, BD Diagnostics.iv v

In the laboratory, the BD MAX System automates sample preparation, extraction, amplification and detection on a single system, saving time and improving lab efficiency.  Molecular testing on the BD MAX System is simplified and standardized, to minimize variability in results.

"The BD MAX Enteric Parasite Panel addition to the menu will further streamline our workflow, improve turnaround time and free up staff that were previously running EIA testing manually," said Annette Monterrubio, Microbiology & Molecular Biology System technical coordinator at St. Luke's Health System, Boise, Idaho. "I believe this will greatly benefit patient care."

The BD MAX menu includes syndromic panels for Healthcare Associated Infections, Reproductive & Sexually Transmitted Infections and Enteric Pathogens, enabling lab professionals in their efforts to deliver diagnostic results that improve lab operations.