Friday, February 23, 2018

Pakistan Hospitals to Get PCR Kits with Free Machines


The Pakistan health department is planning to procure the Rs40 million polymerase chain reaction (PCR) kits for public sector hospitals, asking the successful bidders to provide free diagnostic machines with them.

The department has already installed 10 PCR machines in the province’s teaching hospitals offering free hepatitis tests to visitors.

“Though our machines are functioning well, the technological advancements have led to the manufacturing of better equipment. We will float tenders for the procurement of PCR kits asking the successful bidders to provide us with free machines, too,” manager of the KP Hepatitis Control Programme Dr Kalimullah Khan told Dawn.

He said the new equipment would be placed in hospitals to benefit patients, who required the PCR test at the start and end of the treatment.

Dr Kalim said the visitors to hospitals were screened on rapid immuno-chromatographic test machine for hepatitis C antibodies detection and were subjected to the PCR test after being found positive.

“It is mandatory to do the PCR on patients before prescribing them treatment for hepatitis C. We cannot provide PCR machine to each of 33 sentinel centres for hepatitis patients. The positive cases found on rapid kits are sent to the nearest hospitals, where machines are available,” he said.

Dr Kalim said it was a standard practice that the manufacturers of kits provided new PCR machines to those purchasing them in bulk.

“We will return machines after we exhaust the stock of kits otherwise we will seek free machines from the kit makers after getting a no objection certificate from them,” he said.

He said the use of the existing and new machines would make treatment process easier as the hospitals having molecular biologists would use them.

The anti-hepatitis programme’s manager said a technical committee had finalised the purchase of new kits from the bidders offering the lowest prices and best quality.

“All types of rapid ICT for hepatitis C are imported but we will be evaluating them in the presence of molecular biologists to ensure that no error take place,” he said.

Dr Kalim said normally, a single kit was enough for 100 PCR tests but it could be 90 or 80 tests, which the department would decide before awarding the contract to the supplier.

He said the successful bidder would give a certificate that their product was meant for carrying out quantity of tests.

The anti-hepatitis programme’s manager said they had introduced Sofosbuvir, a new pill given to patients for six months orally, whose results had shown that it was effective in 98 per cent of the cases.

“Now, we have begun administering Daclatasavir to the patients, who use it with Sofosbuvir for three months. We have planned to conduct a study on the efficacy of the new drug after two months for which we will need more PCR machines,” he said.

Dr Kalim said the first PCR test was done to confirm the ailment, while the second was meant to see if the virus has been eliminated.

He said the new tablets were given to 12,000 registered patients free of charge.

Karius Next-Generation Sequencing Blood Test for Infectious Disease Used in a Nohla Phase 2 Cellular Therapy Clinical Trial


Karius, Inc., a life sciences company transforming infectious disease diagnostics with genomics, today announced that they have entered into an agreement with Nohla Therapeutics, Inc. to use the Karius next-generation sequencing (NGS) plasma test for pathogen detection in Nohla’s Phase 2 randomized trial evaluating the company’s lead product, NLA101, in acute myeloid leukemia (AML) patients with chemotherapy-induced neutropenia.

The Karius test for infectious diseases detects microbial cell-free DNA (cfDNA) in plasma from more than a thousand pathogens from a single blood draw in one day using NGS, including bacteria, DNA viruses, fungi and protozoa. The test enables clinicians as well as biopharma partners, such as Nohla, to easily monitor immunocompromised patients for infections. Nohla is using the Karius test to evaluate infections in adult patients with chemotherapy-induced neutropenia who have received their novel cellular therapy NLA101. NLA101 is a universal, off-the-shelf stem and progenitor cell therapy that has the potential to provide short-term hematopoietic recovery and also may provide long term immunologic and clinical benefits. The Karius test provides a quantitative assessment of pathogen DNA in both clinically-documented infections and subclinical infections.

"We're pleased to work with Nohla Therapeutics to provide quantitative monitoring of pathogen DNA to aid in the assessment of patients receiving NLA101 in this trial,” said Dr. David Hong, Karius Medical Director. “Patients undergoing intensive chemotherapy have a higher risk of infectious complications which often are not detected by standard microbiologic techniques. Our comprehensive platform for pathogen detection covers a broad range of over a thousand bacteria, DNA viruses, and eukaryotic pathogens including yeasts and molds. We are excited to work with Nohla as they advance patient care in patients with hematological malignancies.”

This agreement further demonstrates the potential of Karius’ innovative infectious disease platform for the development of novel therapeutics. Karius will provide laboratory testing and analysis services to support Nohla’s Phase 2 Trial, entitled “A Phase 2 Open-Label, Multi-Center, Randomized, Controlled, Dose-Finding Study of NLA101 in Adults Receiving High Dose Chemotherapy for Acute Myeloid Leukemia”. Incorporating the Karius test into the Phase 2 study will enhance the understanding of NLA101’s potential effectiveness in preventing infections.

"The Karius Next Generation Sequencing cell-free microbial DNA test will augment our Phase 2 clinical trial and allow us to evaluate how NLA101 can potentially prevent infections in neutropenic acute myeloid leukemia patients receiving high dose chemotherapy," said Colleen Delaney, MD, Founder and Chief Medical Officer of Nohla. "We look forward to the results of this study and evaluating NLA101’s potential to improve patient outcomes in this high-risk population."

About the Karius Test

The Karius Digital CultureTM Test uses next-generation sequencing (NGS) and analytics for the broad and rapid detection of microbial cell-free DNA through a standard blood draw. Unlike conventional culture and panel testing methods that test for a narrow range of pathogens, the Karius test can detect over a thousand pathogens including bacteria, DNA viruses, and eukaryotic organisms such as yeasts, molds, and protozoa. Results are typically available within one day of sample receipt. Through Karius’ CAP-accredited and CLIA-certified laboratory service, the test empowers doctors to diagnose infections quickly while sparing patients the pain and risk of invasive biopsies, and provide rapid and more targeted treatment.

NYU Researchers Adapt HIV Test in Developing Rapid Diagnostic Test for Zika Virus

Researchers at New York University College of Dentistry (NYU Dentistry), in collaboration with Rheonix, Inc. (Ithaca, NY), are developing a novel test for Zika virus that uses saliva to identify diagnostic markers of the virus in a fraction of the time of current commercial tests.
The test, which was adapted from an existing model developed by NYU and Rheonix for rapid HIV testing, is described in two new publications appearing in PLOS ONE and the Journal of Visualized Experiments (JoVE).

How Zika is Tested

Outbreaks of infectious diseases are occurring with growing frequency thanks to factors such as population concentration and global air travel. A 2015 outbreak of Zika virus in Brazil spread to other countries in Central and South America, the Caribbean, and the Southern United States, leading the World Health Organization to declare Zika and its link to birth defects a public health emergency.

“The recent Zika virus outbreak confirms that we need an effective surveillance and diagnostic program to reduce the impact of future emerging infectious diseases,” said Maite Sabalza, PhD, a postdoctoral associate at the Department of Basic Science and Craniofacial Biology at NYU Dentistry and the lead author of the studies in PLOS ONE and JoVE.

Identifying pathogens early is critical for combatting the spread of infectious diseases. Testing often involves two separate steps: one to detect a pathogen’s nucleic acids (RNA or DNA) and another to test for antibodies, the proteins the body produces in response to pathogens.

Blood samples are most often used to test for Zika virus and are typically processed using a common diagnostic technique called real-time polymerase chain reaction (RT-PCR). But blood may not be the best fluid: While the virus disappears in the blood a week or two after a person is infected, it can persist longer in saliva, semen, and urine. In addition, antibodies can remain for months or years in those bodily fluids, which is why it is essential for diagnosis to also detect antibodies after infection.

Backed by funding from the National Institutes of Health, NYU Dentistry researchers are developing a rapid Zika test that combines both nucleic acid and antibody assays using saliva, given that Zika virus and antibodies persist in saliva. A saliva test is also noninvasive, cost effective, and easier to collect than blood or urine.

Faster Results

The new test also has the potential to produce results in a matter of minutes instead of hours or days. Current RT-PCR tests take around three hours and specific antibody tests can take several weeks. NYU researchers are using a different method called isothermal amplification, which can detect a virus’ nucleic acids in as little as 20 minutes, and antibody tests that can take less than an hour using Zika-specific antigens.

“The sooner you can identify a pathogen, the sooner steps can be taken to treat and isolate people. During an epidemic, you could test people before they get on a plane. The future of going through security at the airport may not be taking off your shoes, but instead spitting into a tube,” said study author Daniel Malamud, PhD, professor of basic science at NYU Dentistry.

From HIV to Zika

The research team is building on its earlier collaborative work with Rheonix developing a rapid saliva test for HIV that can detect both viral RNA and antibodies.
“When we developed the HIV test, we knew we could use the same model for any infectious disease. All we need to know is the nucleic acid sequence and an antigen to identify specific antibodies,” Malamud said.

In PLOS ONE, the researchers describe how they altered this model to use markers that detect Zika nucleic acid sequences instead of those for HIV.  They then used a portable isothermal amplification device – which could be used for point-of-care testing – to identify Zika RNA.
After showing that the test could confirm the presence of the virus using both purified Zika RNA and Zika-infected saliva, they adapted the test to the Rheonix CARD® cartridge and workstation, enabling them to estimate the viral load in saliva samples. Knowing the amount of virus present is useful for understanding disease severity and immune responses, particularly among pregnant women and fetuses.

The researchers also identified Zika-specific antigens – which can be used to detect the Zika specific antibodies needed for testing – using a high density peptide microarray they describe in JoVE. Because Zika can be easily confused with other viruses such as Dengue and Chikungunya, identifying Zika-specific antigens paves the way for more precise diagnostic testing.

With evidence showing that both the nucleic acid and antibody tests work, the researchers can combine them in the Rheonix CARD® cartridge to process both diagnostic assays automatically and simultaneously. Researchers at NYU and around the world are continuing to validate their findings in further experiments using Zika-infected saliva.

“In working towards the goal of quickly making effective diagnostics available, we have developed a generic protocol that can not only be used to test for Zika virus but can be adapted for the next emerging or re-emerging infectious disease,” said Sabalza. Study author Richard Montagna, PhD, FACB, Rheonix’s Senior Vice President for Scientific & Clinical Affairs, added, “In addition to being able to react very quickly to any newly emerging or re-emerging infectious disease, our fully automated testing platform requires virtually no hands-on efforts and is well suited for use by individuals with minimal training.”

In addition to Sabalza, Malamud, and Montagna, study authors on the PLOS ONE article include Cheryl A. Barber, Talita Castro, and William R. Abrams of NYU Dentistry and Rubina Yasmin, Beum Jun Kim, and Hui Zhu of Rheonix, Inc. Barber and Abrams of NYU coauthored the JoVE article.

The research was supported by the National Institute of Dental and Craniofacial Research (NIDCR) of the National Institutes of Health (R44DE024456 and 3R44DE024456-03S1). Support was also provided by a Small Business Innovation Research administrative supplement grant from NIDCR R44 DE024456 that evolved out of NIDCR grant U01 DE017855 for the development of a confirmatory point-of-care diagnostic for HIV.

Source: NYU News, Publications and Facts

Tuesday, February 20, 2018

RPS Diagnostics Partners with Atomo Diagnostics to Develop Next Generation FebriDx Blood Tests for Antibiotic Stewardship

United States biotechnology company, RPS Diagnostics (RPS®), and Australian medical device company, Atomo Diagnostics, announced today that they have entered into a commercial and development partnership to create next generation FebriDx® tests that are anticipated to transform the diagnosis of febrile acute respiratory infections (ARI) at the point-of-care.

The FebriDx test is a rapid, in-office point-of-care test that uses a fingerstick blood sample to provide clinicians with a rapid assessment of the body's immune response to ARIs. The single use, disposable test identifies within 10 minutes patients that have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the simultaneous detection of both Myxovirus resistance protein A (MxA) and c-reactive protein (CRP) directly from peripheral whole blood. MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute-phase inflammatory protein that is elevated in the presence of a clinically significant infection.

"We are excited about our new partnership with Atomo Diagnostics," said Dr. Robert Sambursky, President and Chief Technology and Medical Officer of RPS Diagnostics. "We believe the incorporation of the novel Atomo technology into the existing FebriDx testing system will improve its ease of use and accuracy, allowing for broader acceptance in outpatient settings."

The commercially available, qualitative FebriDx test will now utilize Atomo Diagnostics' all-in-one rapid diagnostic test platform. Unlike standard, multi-component rapid test kits, the unique Atomo platform consolidates the test procedure into a single device. The platform incorporates an in-built safety lancet, calibrated blood collection and delivery system, and integrated push-button buffer delivery mechanism to help prevent user-related errors and improve test performance. FebriDx can be performed easily by untrained healthcare providers and this new partnership will support further expansion into resource limited regions.

Acute respiratory infections are often highly contagious and more than half of all antibiotics are prescribed for outpatients with these infections. ARIs may be associated with nonspecific flu-like symptoms including, fever, sore throat, cough, nasal congestion, and fatigue. Due to overlapping symptoms and signs, it is extremely challenging for physicians to differentiate between viral and bacterial causes of infection during an office visit. Both diagnostic uncertainty and patient or parent pressures for antibiotic prescriptions lead to 50% of antibiotic prescriptions for ARIs being unnecessary.

In a recent study in the United Kingdom, FebriDx was shown to alter clinical management decisions in 48% of patients tested, and to reduce unnecessary antibiotic prescriptions by 80%. By enabling a rapid diagnosis at the office visit, the FebriDx test can help to limit the amount of unnecessary antibiotic prescriptions that may lead to avoidable adverse reactions and antibiotic resistance, resulting in significantly lower costs.

"We believe that rapid viral versus bacterial differentiation is a critical need. We considered a variety of potential partnership opportunities in this area, and believe that FebriDx is the best positioned technology to achieve the greatest impact," said John Kelly, CEO of Atomo Diagnostics. "This exciting new partnership with RPS Diagnostics presents new opportunities for both parties and will further support Atomo's long-term expansion plans."

In addition, RPS and Atomo have commenced development of an enhanced digital single use, disposable version of the test. The digital FebriDx test is planned for U.S. FDA clinical trials.

RPS Diagnostics

RPS Diagnostics is an emerging biotechnology company strategically focused on designing, developing, and delivering novel point-of-care tests for infectious diseases and antibiotic stewardship. RPS Diagnostics is a trade name of Rapid Pathogen Screening, Inc., a wholly owned subsidiary of RPS Diagnostics, Inc. RPS products are developed using a unique, innovative, and patented technology platform that the company can utilize to develop a variety of cost-effective tests. RPS tests allow healthcare providers to more accurately diagnose diseases, provide appropriate and timely treatment, and reduce healthcare costs associated with spread of disease and unnecessary treatment methods. The FebriDx test has received HealthCanada approval, Saudi Arabia FDA clearance, Singapore HSA registration, and is CE marked for sale in Europe. At this time, the FebriDx test has not received U.S. FDA clearance and is not commercially available in the United States.

Atomo Diagnostics

Atomo Diagnostics is a world leader in medical device design and development, based in Sydney, Australia, with corporate offices in the UK and South Africa. The company specializes in developing innovative rapid diagnostic test (RDT) device platforms for capillary blood testing. Atomo's all-in-one devices put the end user first, and help to prevent user errors that are common with standard, multi-component RDT kits. The recipient of multiple international awards for design innovation, Atomo's device platforms make it easy to test and screen for a range of infectious diseases and chronic conditions. As well as commercializing products in its own brand, Atomo provides OEM product development services to specialist diagnostic companies worldwide.

Monday, February 19, 2018

Invisible Sentinel’s First-in-Class, Same-Day Legionella Assay Meets CDC ELITE Requirements

Invisible Sentinel Inc., a Philadelphia-based global molecular solutions company announced today that its first-in-class Legionella species assay has been verified and adopted by Q Laboratories, Inc., a Centers for Disease Control (CDC) ELITE Certified Laboratory.

CDC ELITE, which stands for Environmental Legionella Isolation Techniques Evaluation, is an important CDC designation reserved for laboratories that demonstrate proficiency in isolating, growing, and identifying Legionella from environmental samples using traditional culture-based microbiology methods. Established in 1966, Q Laboratories is based in Cincinnati, Ohio, and provides analytical chemistry, microbiology and research and development laboratory services. Q Laboratories has multiple accreditations including pharmaceutical testing FDA registration, cGMP/GLP, CDC ELITE and ISO/IEC 17025, and is an industry leading laboratory for the testing of food, food ingredients, cosmetics, pharmaceuticals, environmental samples, and water quality.

Legionella causes acute respiratory disease that can lead to hospitalization and death. The bacteria typically reside in water cooling towers, swimming pools, hot tubs and ventilation systems, where it can become aerosolized and infectious to humans. Schools, hospitals, hotels, and long-term care facilities undergo regular monitoring to ensure that they are free of Legionella. However, traditional screening methods can take up to two weeks to deliver results.

Veriflow Legionella is a rapid, molecular assay for the detection of Legionella species from environmental and water samples. The assay provides results in less than 4 hours, improving turn-around-time by more than 7 days compared to the current CDC culture-based method. Veriflow’s innovative DNA Signature Capturing technology is also able to distinguish between viable and non-viable organisms, thus providing same-shift actionable results to end users that can empower near-immediate remediation of contamination.

“We spent several years developing this assay to ensure it would meet the high standards set by ELITE CDC certified testing laboratories and we expect it to be a game-changer for the water testing market,” said Dr. Nicholas Siciliano, Invisible Sentinel’s CEO.

The increasing incidence of Legionella outbreaks, and new regulations calling for increased routine monitoring, have driven the need for faster and more accurate detection tools. “As current demand for rapid and accurate detection of Legionella in water sources increases, the technology offered by Invisible Sentinel’s Legionella assay holds great promise in the water testing market as a new and unique tool allowing detection of only live Legionella cells.,” said Joe Benzinger, Q Laboratories’ Microbiology Research & Development Project Leader.

“We’re excited to partner with Q Laboratories, a market leader in assay validation and microbiology testing services, to formally launch our groundbreaking Legionella assay to the entire industry,” Siciliano added.

Veriflow® Legionella and other assays are available directly from Invisible Sentinel. Invisible Sentinel has also developed a suite of detection tools for pathogen and spoilage organisms in food, wine, beer, and juice.

GenePOC Launches Its revogene™ Instrument and GBS LB Test in Canada

GenePOC Inc., member of the Debiopharm Group™, is proud to announce the launch in its home market for the revogene instrument and the GenePOC™ GBS LB assay.

About Group B Streptococcus (GBS) in Canada

GBS is the leading cause of infection in infants worldwide with a fatality rate between 4-6%[i]. The SOGC guideline[ii] recommends universal antepartum screening for women at 35-37 weeks of gestation, along with intrapartum antibiotic prophylaxis. While this has resulted in a decrease in early onset disease (EOD) rate, there is still an ongoing need for more sensitive GBS detection. In fact, studies have shown that up to 61.4% of term infants with GBS disease are born to women who have had negative cultures for Group B Streptococcus[iii].

About GenePOC GBS LB test

GenePOC GBS LB is indicated for identification of Group B Streptococcus from LIM broth enrichments of vaginal/rectal specimen swabs obtained from pregnant women.

"We are passionate at GenePOC about eliminating the highly debilitating effects of EOD which include meningitis, pneumonia and in some cases death. In launching the GBS LB assay, we are directly addressing that unmet clinical need and meeting the market expectations," said Patrice Allibert, PhD, CEO of GenePOC.

"A dream comes true of bringing a smart and portable device for molecular diagnostics that can replace routine culture methods, giving better performance and much more rapid turnaround times," commented Prof Dr Michel G. Bergeron, from Université Laval and Founder of GenePOC.

References

i. Edmond et al., The Lancet, 2012; 379; p.547-55
ii. Money et al., J Obstet Gynaecol Can 2013;35(10):e1-e10
iii. Van Dyke, et al., NEJM, June 18, 2009; 360(25):2626-36

First Multiplex Test for Tick-Borne Diseases

A new blood test called the Tick-Borne Disease Serochip (TBD Serochip) promises to revolutionize the diagnosis of tick-borne disease by offering a single test to identify and distinguish between Borrelia burgdorferi, the pathogen responsible for Lyme disease, and seven other tick-borne pathogens. Led by scientists at the Center for Infection and Immunity (CII) at Columbia University’s Mailman School of Public Health, the research team report details on the new test in the journal Nature: Scientific Reports.

The researchers—who also include scientists from the Centers for Disease Control and Prevention, National Institute of Allergy and Infectious Diseases, Roche Sequencing Solutions, Farmingdale State College, and Stony Brook University—sought to improve on existing tests for tick-borne diseases (TBDs), which have limited diagnostic accuracy and cannot test for more than one infection simultaneously. Currently, diagnosis of Lyme disease, the most common TBD, requires two separate tests. This cumbersome approach also relies on subjective criteria for the interpretation of results, and accurately identifies fewer than 40 percent of patients with early disease and results in false positives in 28 percent of the time. The accuracy of the method used to diagnose TBDs Babesia, Anaplasma, Ehrlichia, and Rickettsia varies widely among testing laboratories. And for other tick-borne agents, specific blood tests are not yet available, or in the case of the potentially deadly Powassan virus or Heartland virus, are only performed in specialized laboratories.

“The number of Americans diagnosed with tick-borne disease is steadily increasing as tick populations have expanded geographically,” says Rafal Tokarz, PhD. “Each year, approximately 3 million clinical specimens are tested for TBDs in the U.S. Nonetheless, the true incidence of TBDs is likely greatly underestimated, as patients with presumed TBDs are rarely tested for the full range of tick-borne agents, and only a fraction of positive cases are properly reported,” adds Nischay Mishra, PhD. Co-lead authors Tokarz and Mishra are associate research scientists in the Center for Infection and Immunity.

The TBD Serochip can simultaneously test for the presence of antibodies in blood to more than 170,000 individual protein fragments. Version 1.0 can identify exposure to eight tick-borne pathogens present in the U.S., including Anaplasma phagocytophilum (agent of human granulocytic anaplasmosis), Babesia microti (babesiosis), Borrelia burgdorferi (Lyme disease), Borrelia miyamotoi, Ehrlichia chaffeensis (human monocytic ehrlichiosis), Rickettsia rickettsii (Rocky Mountain spotted fever), Heartland virus and Powassan virus. The researchers also included Long Island tick rhabdovirus, a novel virus they recently discovered in Amblyomma americanum ticks. As new tick-borne infectious agents are discovered, the TBD-Serochip will be modified to target them—a process the researchers say can be done in less than four weeks.

The TBD Serochip is also able to identify whether an individual is infected with more than one tick-borne pathogen. Individual ticks are frequently infected with more than one agent; Ixodes scapularis ticks alone can transmit at least five human pathogens. Evidence of exposure to other tick-borne pathogens in patients with Lyme disease has been well documented. In the new paper, the researchers report finding antibodies to another agent in 26 percent of blood specimens from patients with TBD.

In addition to its utility as a diagnostic platform, the TBD Serochip also provides a powerful research tool for studies of TBDs. The technology can be employed to discriminate individual antibody responses in patients with TBD and thus examine the interplay of TBD agents on disease manifestation and progression. It can also be used to assess the impact of genetic diversity of tick-borne pathogens on the host immune response.

“Diagnosing tick-borne illness is a difficult journey for patients, delaying effecting treatment,” says senior author W. Ian Lipkin, MD, director of CII and John Snow Professor of Epidemiology at Columbia University’s Mailman School of Public Health. “The TBD Serochip promises to make diagnosis far easier, offering a single, accurate test for eight different TBDs. Early detection of infection enables rapid and appropriate treatment.”

o-authors include Thomas Briese, Teresa Tagliafierro, Stephen Sameroff, Adrian Caciula, Lokendrasingh Chauhan, of CII; Jigar Patel and Eric Sullivan of Roche Sequencing Solutions, Madison, WI; Azad Gucwa of Farmingdale State College, Farmingdale, NY; Brian Fallon of Columbia University; Marc Golightly of Stony Brook University; Claudia Molins and Martin Schriefer of Centers for Disease Control and Prevention; and Adriana Marques of National Institute of Allergy and Infectious Diseases.

This study was funded through grants from the Steven & Alexandra Cohen Foundation and the National Institutes of Allergy and Infectious Diseases (AI109761). The content of study does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. CII has filed an invention report and provisional patent application for the technology.

Wednesday, February 14, 2018

Bruker MALDI Biotyper Solution Receives AOAC International Approvals for Two Official Methods of Analysis (OMA) in Food Microbiology

Bruker is pleased to announce that AOAC International has approved the MALDI Biotyper solution for two new Official Methods of Analysis (OMA) for the confirmation and identification of pathogenic and non-pathogenic bacteria.  The two methods include some of the most common food pathogens, including Salmonella spp (spp means all species of the genus Salmonella), Cronobacter spp, Listeria spp and Listeria monocytogenes, as well as the identification of other Gram-negative and Gram-positive bacteria.  Confirmation and identification can be performed directly from several selective culture media that are widely used in food microbiology, or from any non-selective culture plates.

The added value of using the MALDI Biotyper as a very fast and cost-effective microbial confirmation and identification solution is now also broadly available for food safety authorities, for food industries, and other food and feed testing facilities.  This can improve efficiency in food testing laboratories and accelerate the turn-around time for food producers until critical production steps are monitored, and lots can be released.

Validation studies have proven the performance of the MALDI Biotyper for the direct confirmation and identification of bacteria from the selective media recommended by the FDA, ISO and USDA, as well as from several chromogenic media, and from any non-selective culture media.  The approved benchtop MALDI Biotyper system is also available as an MBT smart version with an even faster, proprietary smartbeam™ laser that further accelerates the speed of analysis and decreases time-to-result.

The MALDI Biotyper Subtyping Module enables a high confidence differentiation of the Listeria species.  The MALDI Biotyper workflow can be supported with the MBT Pilot™ for optically guided sample preparation on the MBT target plates, and with the MBT Galaxy™ for automated matrix deposition during the sample preparation.  Both workflow tools further improve the productivity and workflow standardization.  New disposable MBT Biotargets 96 plates based on Bruker´s proprietary AnchorChip™ technology can be used for optimal performance.

Erin Crowley, the Chief Scientific Officer at Q Laboratories in Cincinnati, Ohio, commented:  "Q Laboratories was grateful for the opportunity to serve as the Expert Laboratory on these two OMA validation studies.  The success of these projects was supported by the easy workflow of the MALDI Biotyper. We have implemented the MALDI Biotyper in our facilities since 18 months already.  It is truly an innovation and its OMA approval is a significant step to provide our customers with rapid and accurate identification and confirmatory options needed to make critical decisions."

Q Laboratories Inc. is an ISO/IEC 17025 accredited laboratory providing comprehensive microbiological, analytical chemistry and R&D laboratory services to companies around the world.  In business since 1966, Q Laboratories serves the food, pharmaceutical, cosmetic, dietary supplement and personal care product industries and is the first Expert Laboratory in North America to be recognized by the three major certification bodies AFNOR, AOAC International and MicroVAL.

Dr. Daniele Sohier, Business Development Manager for Industrial Microbiology at Bruker Daltonics, added: "Working in collaboration with AOAC International and Q Laboratories was a real pleasure and very efficient.  We were able to get these two OMA claims in only 6 months, corroborating the reliability and robustness of the MALDI Biotyper for fast and accurate confirmation of many foodborne pathogens and for the identification of other bacteria.  The MALDI Biotyper is broadly used in clinical microbiology already.  With the AOAC International approvals for two OMAs, we now also have access to regulated food microbiology markets, which represents a further significant market expansion for the MALDI Biotyper."

About the Bruker MALDI Biotyper (MBT) Platform

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

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

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

DARPA Awards MBio Diagnostics Phase II Contract for Acute Infection Point-of-Care System

MBio Diagnostics, Inc., a company leading a new era in rapid, on-the-spot clinical diagnostics and sample testing, today announced a contract with the US Defense Advanced Research Projects Agency (DARPA) entitled, “Point-of-care Monitoring of the Host-Pathogen Interaction During Infection.” The Phase II DARPA contract builds on a successful Phase I program focused on development of a portable, multiplexed immunoassay system that rapidly delivers a panel of host response biomarker results. The DARPA project complements MBio’s NIH-funded program entitled “Point-of-Care Prognostic Tool for Sepsis,” which kicked off in September 2017. The NIH program is for development of a prognostic tool to aid in stratifying sepsis patients with highest risk of mortality. The combined value of these contracts, if all phases and options are awarded, is $1.5 million. Both programs are in collaboration with Dr. Hector Wong, Director of the Division of Critical Care Medicine at Cincinnati Children’s Hospital Medical Center.

Infection and tissue damage lead to release of signaling proteins into the bloodstream of the patient. An ability to rapidly analyze panels of these so-called host response markers can enable new diagnostic and prognostic approaches that can potentially lead to significantly more effective patient management during the time-critical phase of acute infection. According to MBio CEO Chris Myatt, “Managing acute infections accurately and quickly is a critical task in the healthcare system. MBio brings a unique approach to testing that provides multiple, high-sensitivity quantitative results in a simple, point-of-care device. Our goal is to help transform the management of severely ill individuals by delivering biomarker panel results in minutes in the emergency department or intensive care unit, rather than waiting hours for laboratory tests.” Dr. Myatt added on the Cincinnati collaboration, “Adapting high-value content, such as derived from Dr. Wong’s outstanding investigations of pediatric and adult sepsis patients, provides unique solutions to very challenging healthcare problems.”

About MBio Diagnostics

MBio Diagnostics is leading a new era in rapid, on-the-spot clinical diagnostics and sample testing. Our portable MBio Array System and disposable cartridges enable low-cost, rapid answers in 1 to 20 minutes. MBio aims to be the platform of choice for leading providers and users of clinical and analytical testing services in all market segments including: medical, veterinary, environmental, food, agricultural and military.

Quidel Receives 510(k) for QuickVue® Influenza A+B Test, Assay Meets FDA’s Class II RIDT Requirements

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Quidel’s CLIA Waived QuickVue® Influenza A+B assay for the rapid, differential detection of influenza types A and B.

In a recent clinical study, Quidel’s QuickVue® Influenza A+B test was shown to meet the FDA’s reclassification criteria for Class II Rapid Influenza Diagnostic Tests and is available for sale in the United States. The assay allows for the rapid, qualitative detection of influenza type A and type B antigens directly in nasal swab and nasopharyngeal swab specimens from symptomatic patients.

"Influenza is a highly contagious, acute, viral infection of the respiratory tract, and rapid diagnosis is critical to avoid potentially serious complications. Recent CDC figures and positivity rates from our Sofia analyzers suggest that this year’s influenza season may be getting worse, not better, and has surpassed the rate of every other year except the unusual pandemic of 2009. Quidel’s QuickVue® Influenza A+B test identifies and differentiates influenza type A and B in approximately 10 minutes aiding in better patient management decisions for healthcare professionals,” commented Douglas Bryant, president and chief executive officer of Quidel Corporation.

The causative agents of the disease are immunologically diverse, single-strand RNA viruses known as influenza viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with the most serious epidemics. Type B viruses produce a disease that is generally milder than that caused by type A. Type C viruses have never been associated with a large epidemic of human disease. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season.(1)

Reference

1. Murphy, B.R., and R.G. Webster. Orthomyxoviruses, In: Fields Virology, 3rd edition, B.N. Fields, D.M. Knipe, P.M. Howley, et al. (eds.), Lippincott-Raven, Philadelphia. 1996, pp. 1397–1445.

Tuesday, February 13, 2018

CERTUS Begins Manufacturing of Novel In-House Pathogen Detection System with Toho Technology

CERTUS, innovators in food safety technologies, has begun manufacturing of the CERTUS System Detection Unit, bringing small and mid-sized food processing plants one step closer to a fast, easy and cost-effective way to detect pathogens. Based on SERS nanoparticle technology made available through an exclusive license agreement with BD (Becton, Dickinson and Company), a leading global medical technology company, the CERTUS System is an entirely in-house system, enabling food producers to perform environmental monitoring without the need for outsourced testing. With the commencement of manufacturing, the CERTUS System Detection Unit is on track for market availability in June 2018.

Manufacturing of the Detection Unit is being carried out at CERTUS’ parent company and iconic precision manufacturer Toho Technology. Founded in 1819 in Nagoya, Japan, Toho is a privately-held company that provides engineering, manufacture, distribution and support of diverse industrial and life-science technologies to customers around the world.  With a well-established global market presence in optical instrumentation in the fields of semiconductor, flat panel display and process engineering, CERTUS leverages the Toho team and talent to advance out of R&D and into full scale commercial production.

“Being part of the Toho Technology family provides us with a myriad of technological and commercial benefits to ensure our products exceed the market’s expectations for precision and accuracy,” said CERTUS Director of Product Development, Dr. John Bodner. “Not only does Toho provide significant expertise in the manufacture of precision instrumentation, they also provide CERTUS with the solid infrastructure and financial backing needed to bring this level of innovation to our customers.”

In addition to partnering with Toho, CERTUS works with United Kingdom-based Solus Scientific for assay development. “One of the reasons we chose to partner with Solus is because of their efficient research and development track record on bringing to market a range of assays in the area of food safety testing,” continued Bodner.

The CERTUS Listeria El assay was developed in collaboration with Solus in 2017, while the environmental Salmonella assay is currently under development and expected to be available for use in the CERTUS System as early as Q4 of this year.

“Through BD’s exclusive license to CERTUS and our strategic partnerships with Toho and Solus, we can ensure best-in-class products for our clients, with the end goal of removing the most harmful pathogens from the food system,” said Bodner.

The CERTUS System will be commercially available in June 2018 and will feature a simple workflow, Bio-Lock™ safety components and real-time monitoring for rapid results.

OpGen Strengthens Supplier Relationship to Use Industry-Leading Real-Time PCR Technology for New Acuitas® Tests

OpGen, Inc. announced today that it has entered into a global supply agreement to use Thermo Fisher Scientific’s real-time PCR technology in the company’s Acuitas® AMR Gene Panel Tests.  The first test, the Research Use Only (RUO) AMR Gene Panel u5.47, is available for infection control purposes and pharmaceutical surveillance research. OpGen is planning clinical trials to support regulatory submissions for broader clinical use in patients with complicated urinary tract infections (cUTI).

Recent studies have indicated that antimicrobial resistant infections currently claim 50,000 lives each year across the United States and Europe alone, with many hundreds of thousands more dying in other areas of the world.  OpGen is addressing this global threat with innovative technologies that enable rapid and precise identification of antimicrobial resistance.

Effective, targeted antimicrobial treatment is of critical importance in patients with cUTI and other serious infections as the emergence and spread of antimicrobial-resistant organisms increase. There are an estimated 400,000 to 800,000 patients each year in the U.S. with cUTI, and approximately half are at risk for multidrug-resistant infections. Complicated UTI continues to be a major cause of hospital admission, morbidity, mortality and excess health care costs as a growing number of infections are healthcare associated in origin.

The new Acuitas AMR Gene Panel u5.47 RUO test detects 47 gene targets which span 600 subtypes and convey resistance to 9 classes of antibiotics directly from urine and isolated colonies.  From urine specimens, the Acuitas AMR Gene Panel u5.47 RUO will semi-quantitatively detect the most common bacterial causes of cUTI (E. coli, K. pneumoniae, P. aeruginosa, P. mirabilis, E. faecalis). Test results are provided in under three hours compared with traditional microbiology methods, which can take two to three days.

In an easy-to-use laboratory protocol, the Acuitas AMR Gene Panel u5.47 RUO test will incorporate Thermo Fisher’s TaqMan® Fast Advanced Master Mix and TaqMan® Probes for quick, multiplexed gene detection. The genetic results may be analyzed in OpGen’s Acuitas Lighthouse® Knowledgebase bioinformatics system to help healthcare providers rapidly and accurately identify antimicrobial resistance.

“We are pleased to expand our relationship to include these market-leading real-time PCR technologies. In 2017 we entered into an agreement to use the QuantStudio™ 5 Real-Time PCR System. The combination of these technologies, along with OpGen’s innovative solutions, will aid laboratories and healthcare providers in the fight against antimicrobial resistance,” said Evan Jones, Chairman and CEO of OpGen. “Thermo Fisher’s market-leading position in PCR and its global installed base makes it an ideal partner for our Acuitas Rapid Test.”

TaqMan® Fast Advanced Master Mix, TaqMan® Probes and QuantStudio™ 5 Real-Time PCR System are for research use only and are not intended for diagnostic procedures.

DARPA Program Aims to Develop Biosurveillance Tech for Screening 'Unfamiliar' Bacterial Strains

Recognizing the threat that unpredictable biohazards could pose, the Defense Advanced Research Projects Agency (DARPA) has proposed development of a new biosurveillance technology that would rapidly screen unfamiliar bacteria to establish their capacity to harm.

The program, “Friend or Foe,” intends to go where existing forensic technologies can not. Older methods are primarily locked to the 350-known strains and cultured bacteria addressed under diagnostic microbiology, or the practice of metagenomics, which simply inventories previously known bacteria. The new method, on the other hand, would catalog unknown pathogenic traits and track unfamiliar bacteria. What’s more, it proposes to do so in less than the 36-hour (minimum) window of its forebears.

“Trends such as rising global population, changes in the environment, and the growing accessibility of tools for genetic engineering mean that our armed forces are increasingly likely to face new bacterial pathogens, whether they occur naturally or are engineered by adversaries,” Paul Sheehan, the program manager for the Friend or Foe technology, said. “Our existing biosurveillance strategies don’t work on previously undiscovered bacteria or on bacteria that have been specifically designed to evade detection by current tests. We need new screening tools that can quickly characterize the threat to enable a rapid response.”

Current efforts leave the world vulnerable to large categories of previously unknown bacteria, and part of that is in what they read. The previously mentioned tend to stick to genotypes–genetic makeups–of their subjects, as opposed to phenotypes–how the bacterium’s genetic code leads to function–which the Friend or Foe tech proposes to address. Using that basis, it aims to test three things: if bacteria can survive and establish itself in a host, if the bacteria can harm its host, and if the bacteria can protect itself.

“There are millions of species of unidentified bacteria in the world, and we now have no quick way of knowing which of those might endanger our troops,” Sheehan said. “If we’re successful in creating a tool for rapid evaluation of bacterial phenotype, we’ll deliver the Defense Department a powerful new capability for force protection and a powerful deterrent to the development of engineered bio-threats.”

The program for development of Friend or Foe would be a four-year research program, supported by an independent verification and validation team.

FDA Clears Tests from Alere, Roche, Cepheid in January

Abbott's Alere business, along with Roche, Becton Dickinson, and Danaher's Cepheid each received US Food and Drug Administration clearances for tests in January, according to the FDA's website.

Alere, acquired by Abbott in October 2017, received clearances for four tests.

They include the Alere i Influenza A & B, which is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B in patients presenting with symptoms of respiratory infection. The firm received clearance for Alere i Strep A, a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens, and for Alere i RSV, a rapid, instrument-based isothermal test for the qualitative detection and differentiation of respiratory syncytial virus viral RNA in patients with symptoms of respiratory infection.

The FDA cleared Alere i Influenza A & B 2, a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B in patients presenting with symptoms of respiratory infection.

Around midmonth, the FDA granted clearance to Roche for its Cobas Factor II and Factor V test, which uses real-time PCR for the detection and genotyping of the Factor II G20210A mutation and the Factor V Leiden G1691A mutation in DNA that's obtained from K2EDTA whole blood specimens. The tests aid in the diagnosis of patients with suspected thrombophilia.

Becton Dickinson received clearance for its Phoenix automated microbiology system for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for enterobacteriaceae and non-enterobacteriaceae, and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

The FDA granted clearance for Danaher's Cepheid Xpert Carba-R Assay, an automated real-time PCR diagnostic test for the qualitative detection of several gene sequences from rectal or perirectal swab specimens or isolates of pure cultures of gram-negative bacteria that are not susceptible to carbapenem. The assay is intended as an aid for infection control and for monitoring the spread of organisms that are not susceptible to carbapenem in healthcare settings.

Additionally, Cepheid received 510(k) clearance and CLIA waiver from the FDA for a new test system and influenza molecular diagnostic test.

The test, called Xpert Xpress Flu, can be used in near-patient settings to detect both A and B strains of influenza from either nasopharyngeal or nasal swabs. It targets multiple regions within the RNA-based influenza genomes to increase sensitivity and guard against antigenic drift.

Other companies that received FDA clearance for their tests or testing systems in January include Meso Scale Diagnostic, which received clearance for its conventional C-reactive protein assay, which is based on the company's Multi-Array technology.

Qiagen received clearance for its Ipsogen JAK2 RGQ PCR Kit for additional use in the diagnosis of all myeloproliferative neoplasms.

In March 2017, the FDA had cleared the assay as a qualitative in vitro diagnostics test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood to aid in the diagnosis of the blood cancer polycythemia vera.

Qiagen also received clearance for extended indications for use of its Therascreen EGFR RGQ PCR kit to guide the use of Boehringer Ingelheim's Gilotrif (afatanib) for first-line treatment of patients with metastatic non-small cell lung cancer harboring non-resistant EGFR mutations.

Specifically, FDA approved a premarket authorization supplement extending the labeling claim of the Therascreen kit to include detection of EGFR mutations L681Q, G719X, and S7681 to help identify NSCLC patients for whom Gilotrif is indicated.

Sebia received clearance for its Hydrashift 2/4 daratumumab assay for evaluating multiple myeloma patients treated with Darzalex (daratumumab).

The assay was developed in collaboration with Janssen Biotech, which jointly developed Darzalex with Genmab. Sebia is the worldwide supplier of the assay, which received CE mark in November 2016, and runs on the Sebia Hydrasys 2 agarose gel platform.

The FDA granted premarket approval for Hologic's Aptima HBV Quant Assay for quantitation of hepatitis B viral load on its fully automated Panther system.

The assay reliably quantitates HBV DNA across genotypes A-H, provides a dual-target approach that delivers accurate quantitation over a broad linear range, and tolerates potential mutations in the HBV genome, Hologic said.

Techlab received 510(k) clearance for two tests intended to aid in the diagnosis of campylobacteriosis, which is produced by Campylobacter, a foodborne pathogen that's among the most common causes of diarrheal illness in the US.

The FDA cleared Bio-Rad Laboratories' IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents for manual blood typing.

Diazyme Laboratories received 510(k) clearance for its fully automated two-reagent EZ Vitamin D assay for use on validated clinical chemistry analyzers.

The FDA expanded the indication for AstraZeneca's PARP inhibitor Lynparza (olaparib) for metastatic breast cancer patients who have BRCA-mutated tumors.

Simultaneously, the agency also expanded the indication for Myriad Genetics' BRACAnalysis CDx as a test that can identify which breast cancer patients have germline BRCA mutations and therefore are most likely to benefit from Lynparza.

And Inova Diagnostics received clearance for its Quanta Flash Calprotectin assay for the detection of fecal calprotectin in human stool samples.

Curetis Unyvero HPN Application Receives Singapore Health Sciences Authority Approval; Updates on Sepsis Host Response Test

Curetis N.V., a developer of next-level molecular diagnostic solutions, announced that Acumen Research Laboratories Pte Ltd. (Acumen), its partner for the commercialization of Unyvero in the ASEAN region, has received approval by the Singapore Health Sciences Authority (HSA) to market the Unyvero HPN Hospitalized Pneumonia Application Cartridge in Singapore.

With this approval, Unyvero HPN is now fully registered as a Class C IVD medical device with the Singapore Medical Device Register (Device Registration No: DE0501196). After the initial placement of Unyvero Systems under the GN-27 exemption at early adopter sites such as Raffles Hospital, Farrer Park Hospital, and Parkway Laboratories, the HSA approval now allows for a more comprehensive roll-out in Singapore as a bridgehead to the ASEAN region. Acumen expects that the approval in Singapore will facilitate market entry into other countries of the region including Malaysia, Indonesia, and Thailand going forward.

The HSA review and approval process for the Unyvero BCU Blood Culture Application Cartridge as a second application for the Singaporean and ASEAN markets is ongoing. Acumen and Curetis further intend to submit the Unyvero ITI Implant and Tissue Infection and Unyvero IAI Intra-Abdominal Infection Application Cartridges for HSA approval.

Curetis and Acumen also announced that the development of the Unyvero SHR Sepsis Host Response Application Cartridge for the rapid identification of patients with bloodstream infections and sepsis has been completed. The cartridge is based on a proprietary gene expression biomarker panel licensed by Curetis from Acumen in 2015. In the coming months, the Companies expect to initiate clinical validation work on this first cartridge-based rapid molecular test for sepsis alongside a laboratory-developed test (LDT) based on the same biomarker panel already offered by Acumen to hospitals in Singapore. The validation work will focus on demonstrating concordance of the analytical and clinical performance of two tests in the same patient population.

"In only four to five hours, the new Unyvero HPN test enables detection of 21 pathogens and 19 antibiotics resistance markers that are highly relevant for the diagnosis of hospitalized patients with suspected pneumonia. This will not only help to improve outcomes for these patients, but also facilitate the more prudent use of antibiotics and thereby help mitigating the growing antimicrobial resistance challenge," commented Siew Hwa Ong, PhD, CEO of Acumen. "We are also pleased with the progress of the Unyvero SHR Application Cartridge building on our biomarker panel, as this rapid and easy-to-use molecular test bears great potential in addressing the diagnostic challenges clinicians are facing in treating sepsis."

"This first approval of a Unyvero Application in an Asian market serves as a bridgehead to the entire ASEAN region and marks an important milestone in the commercial growth strategy of Curetis," said Oliver Schacht, PhD, CEO of Curetis. "With an expected near-term clearance decision from the U.S. FDA for the Unyvero Lower Respiratory Tract Application and the solid progress we are making with our partner Beijing Clear Biotech with regulatory studies in China, we are setting the stage for significant commercial expansion of Unyvero in the years to come."

About Acumen Research Laboratories

Acumen Research Laboratories, based in Singapore, was founded in 2010. The company has strong capabilities in translational research for developing molecular diagnostics using gene-based biomarkers, with approaches that focus on in-depth clinical validation early in the development process. Acumen is one of the few industry leaders in host-based, gene expression sepsis diagnostics. Acumen has received strong support from several Singapore government agencies such as SPRING Singapore, the country's enterprise development agency, the National University of Singapore Enterprise Centre and the Diagnostics Development (DxD) Hub, of the Agency for Science, Technology and Research (A*STAR).

About Curetis

Founded in 2007, Curetis is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis enable rapid multi-parameter pathogen and antibiotic resistance marker detection in only a few hours, a process that today can take up to days or even weeks with other techniques.

To date, Curetis has raised EUR 44.3 million in an IPO on Euronext Amsterdam and Euronext Brussels and private equity funds of over EUR 63.5 million. Furthermore, Curetis has entered into a debt financing facility with EIB for up to EUR 25 million. The company is based in Holzgerlingen near Stuttgart, Germany. Curetis collaborates with Heraeus Medical, pharmaceutical companies, and has entered into several international distribution agreements covering many countries across Europe, the Middle East and Asia.

In 2017, Curetis established Ares Genetics GmbH, a wholly-owned subsidiary of Curetis GmbH in Vienna, Austria. Ares Genetics is dedicated to maximize the R&D and related scientific and business opportunities of the GEAR assets acquired in 2016 for the entire Curetis Group.

Saturday, February 3, 2018

3M Food Safety’s Two-in-One 3M Petrifilm Plate Reveals Next-Day Results for Both E. coli and Coliforms

3M Food Safety introduced the 3M™ Petrifilm™ Rapid E. coli/Coliform Count Plate, a two-in-one indicator test that gives the customer both an E. coli and total coliform count in 18-24 hours. In addition to possessing all of the simple, reliable and sustainable conveniences that have made the 3M™ Petrifilm™ brand a go-to test for decades, the new plate distinguishes E. coli from other coliform bacteria in only 18 to 24 hours for a wide variety of food samples, allowing processors to operate more efficiently and ship their products sooner.

Available worldwide, the 3M Petrifilm Rapid E. coli/Coliform Count Plate joins the growing family of 3M™ Petrifilm™ Plates providing rapid results.

“Our aim, always, is to develop highly accurate tests and technologies that result in less waiting and increased efficiency for our customers,” said Chris Somero, 3M Food Safety marketing manager. “This new plate is an all-in-one, easy-to-use chromogenic solution that can immediately boost productivity and accelerate their products’ time to market.”

Customers from around the world were impressed with the 3M Petrifilm Rapid E. coli/Coliform Count Plate upon seeing a preview. Customers mentioned they found it easy to use and that the benefits of not having to incur the time and hassle of manually preparing agar or using special equipment to enumerate were just some of the advantages of the new plate.

3M Food Safety, a leader of innovative solutions that help the food and beverage industries optimize the quality and safety of their products to enable consumer protection and improve their bottom lines, is pursuing a third-party harmonized AOAC/MicroVal validation (ISO 16140-2 protocol) for its new technology.

PositiveID Corporation Publishes White Paper and Data on its Successful Detection of Influenza Virus

PositiveID Corporation, a life sciences company focused on detection and diagnostics, announced that it has published a white paper and data on its successful detection of the influenza virus on its FireflyDX polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”). The white paper can be found by clicking here.

According to a recent Washington Post article citing federal health officials, this year's flu season is already the most widespread on record, and has already caused the deaths of more children than what normally would be expected at this time of the year. More than 8,900 people have been hospitalized with laboratory-confirmed influenza since the season started October 1.

PositiveID’s FireflyDX prototype system has successfully detected influenza virus. The FireflyDX family of products is designed to provide accurate, rapid pathogen detection at the point-of-care/point-of-need (POC/PON) using real-time PCR in less than 30 minutes, with minimally trained personnel and at a lower cost than existing systems. Current solutions for accurately identifying potential pathogens and bio-threats, especially at the POC/PON, can sometimes take as long as several hours to several days to provide results, dramatically delaying what is often life-saving treatment, while also increasing costs, both personal and financial.

Five different flu virus assays (Type A; Type B; H3N3; H7N1; and, H5N1) were tested on the FireflyDX prototype system; a disposable PCR chip was loaded with the reaction and then inserted onto the FireflyDX prototype system, and the automated runs successfully synthesized cDNA using a reverse transcriptase step and then completed a 40-cycle PCR to produce the detected target results.

PositiveID and its ExcitePCR subsidiary are developing FireflyDX, in both portable and handheld forms, to enable accurate, fast, safe, cost-effective diagnosis in the field, which may offer a highly disruptive breakthrough in combatting influenza, which is often diagnosed with a rapid influenza detection test (“RIDT”). RIDTs are not as accurate, however, as lab-based testing such as PCR. In fact, the CDC recommends that if an important clinical decision is affected by a flu test result, the RIDT result should be confirmed by a molecular assay such as PCR.

“According to the CDC, this year’s flu season is geographically widespread and patients’ health complications are abnormally high,” stated William J. Caragol, Chairman and CEO of PositiveID.  “Unfortunately, as is often the case, because lab-based testing demands both significant time and financial resources, many people being tested at the point of care or point of need with rapid influenza detection tests are getting results that are only partially accurate, or worse, not accurate at all. This may allow the flu epidemic to worsen. Fast, affordable point-of-need diagnostics should be the first line of defense, and we are developing our technology to offer just such a solution,” continued Caragol.

The predominant influenza strain this year is H3N2, which experts believe can present serious health complications. It adapts quickly to vaccines and immune responses and often leads serious outbreaks of the two influenza A viruses and two types of influenza B viruses. Seasons when the H3N2 strain dominates are associated with high levels of hospitalizations, deaths and illness.

In addition to influenza virus, the FireflyDX prototype system has also successfully detected a number of other pathogenic organisms including Zika, Ebola, E. coli, influenza, MRSA, MSSA, C. diff and others.

Mesa Biotech Obtains CE Mark for its Accula™ Point of Care Testing System

Mesa Biotech Inc., a privately held, molecular diagnostic company that has developed an affordable PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, announced that it has obtained CE Mark in the European Union (EU) for its Accula™ System. The first available test in the EU market will be the company's Flu A/Flu B Test.

Diagnosis of influenza is difficult because the initial symptoms can be similar to other upper respiratory virus infections. The FDA, CDC, and WHO all acknowledge that existing POC immunodiagnostic tests perform poorly. Molecular testing is recommended, as influenza is a rapidly evolving virus. Further, because antiviral medications for influenza are only effective when taken within 48 hours of symptom onset, rapid diagnostics are required to direct therapy for these viral infections.

The Accula System, a palm-sized, reusable dock with disposable test cassettes, offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays, while providing the superior sensitivity, specificity and information content of laboratory-based PCR testing. Test results are available in approximately 30 minutes. The Accula Flu A/Flu B test is indicated for use with nasal swab collection that is less invasive than nasopharyngeal swabs and allows for a more comfortable specimen collection experience for the patient.

"The introduction of the Accula System and its Flu A/Flu B test as our first PCR assay in the European market is an important validation of our platform and a critical strategic milestone for Mesa Biotech. Our proprietary assay design enables rapid development of a portfolio of cassettes to test for human, agricultural, food pathogens, or genetic disease targets," said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. "The CE Mark indicates a product's compliance with applicable EU regulations and enables the commercialization of our products. This, in turn, will provide significant benefits to clinicians and patients by offering reference laboratory performance at the point-of-care."

According to the WHO, annual influenza epidemics are estimated to result in about three to five million cases of severe illness, and about 250,000 to 500,000 deaths. In industrialized countries, most deaths associated with influenza occur among people age 65 or older. Epidemics can result in significant work/school absenteeism and productivity losses. Clinics and hospitals can be overwhelmed during peak illness periods. The estimated economic burden of influenza-like illness ranges between $71-$163 billion in the U.S. alone.

About Mesa Biotech Inc.

Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech's technology development has been funded to date by a series of grants and private equity investments.

Scientists Develop New, Low-Cost Tool for Detecting Bacteria in Food and Water

Food scientist Lili He and colleagues at the University of Massachusetts Amherst report that they have developed a new, rapid and low-cost method for detecting bacteria in water or a food sample. Once commercially available, it should be useful to cooks using fresh fruits and vegetables, for example, and aid workers in the field responding to natural disasters, He says.

An analytical chemist and expert in detection methods for food contamination, He says, "Most people around the world cook their vegetables before eating, but here in the U.S. more and more people like to eat these foods raw. This gave us the idea that a quick test that can be done at home would be a good idea."

She adds, "Microbial contamination is an important research topic right now.  "It has been a problem for a long time, but it is now the number one concern for food safety in the U.S."
He, with fellow food science researcher Lynne McLandsborough and their students, in particular first author Brooke Pearson, reported on their new two-step method - one optical, one chemical - in two papers this year, one in a recent early online issue of Food Microbiology scheduled for publication in 2018, and an earlier one in the Royal Society of Chemistry's journal, Analytical Methods.

For this work, they designed a sensitive and reliable bacteria-detecting chip that can test whether fresh spinach or apple juice, for example, carry a bacterial load. The chip, used with a light microscope for optical detection, relies on what He calls a "capture molecule," 3-mercaptophenylboronic acid (3-MBPA) that attracts and binds to any bacteria. The chemical detection method, "surface-enhanced Raman spectroscopy" (SERS), relies on silver nanoparticles. The techniques are now in the patenting process.

Over the past summer, the optical detection method was adapted for possible home use with a smart phone microscope adapter that is widely available online for about $30. The first step in the new test for bacteria detection is to collect a sample of water, juice or mashed vegetable leaf and place the chemical-based detection chip in with the sample. A summer high school student in He's food science laboratory developed a simple smart phone app that visually detects bacteria in samples that contain the chip. "This is just the beginning of the work," says He. She hopes to receive more funding to continue this practical application.

The standard method for culturing bacteria from food samples, known as an aerobic plate count (APC) takes two days, He explains. "There are some others that are faster, but they are not very sensitive or reliable because ingredients in the food can interfere with them. We show in our most recent paper that our method is both sensitive and reliable and it can give you results in less than two hours."

To address the food interference problem, the researchers designed the UMass Amherst chip to attract only bacteria but not sugars, fats and proteins in food or dirt. The food compounds can be washed away with a high-pH buffer, the food chemist says, leaving only bacteria for visual counting with the smart phone microscope and app. This method can detect as few as 100 bacteria cells per 1 milliliter of solution, compared to a sensitivity of 10,000 cells for other rapid methods.

In their recent study, He and colleagues explored "the advantages and constraints of this assay over the conventional APC method and further developed methods for detection in real environmental and food matrices," the authors explain. "This study advanced the SERS technique for real applications in environment and food matrices," they point out.

Reference:

Brooke Pearson et al, Rationalizing and advancing the 3-MPBA SERS sandwich assay for rapid detection of bacteria in environmental and food matrices, Food Microbiology (2017). DOI: 10.1016/j.fm.2017.11.007