Friday, December 28, 2012

Researchers Work to Develop Early Campylobacter Detection

Researchers at Swinburne University of Technology are working to develop early detection of Campylobacter jejuni bacteria - a significant contributor to foodborne illness in Australia and around the world.

Current testing methods to detect the bacteria are time consuming, as growing samples for genotyping analysis takes three to four days, which can make tracing the origin of contamination difficult.

Swinburne PhD student Monir Ahmed has been focusing on more rapid ways to detect Campylobacter jejuni with the help of a research scholarship from the Victorian Department of Health.

Using samples from the University of Melbourne’s Microbiological Diagnostic Unit, Ahmed is working to identify a selection of toxin genes associated with the Campylobacter infection. He uses Swinburne’s MALDI-TOF mass spectrometer to accurately identify strain-specific metabolic fingerprints. The results are then fed into a database of different cell proteins allowing the comparison of new strains with those previously identified.

According to Professor Elena Ivanova, Ahmed’s PhD supervisor, this method enables faster analysis.

“You can get the preparation stage down to one day and then get the results through the MALDI-TOF in half an hour,” Ivanova said.

“This greatly reduces the time and effort required to identify the origin of a Campylobacter jejuni contamination, meaning that improved education, regulation or clean-up policies could be applied, therefore addressing some of the public health costs.”

The ultimate aim of the research is to develop a portable biosensor to assist in tracing the source of theCampylobacter contamination.

ICMR to Commercialise Novel Primers for PCR-RFLP Assay to Identify Species-Specific Pathogenic Mycobacteria

The Indian Council of Medical Research (ICMR) will soon commercialise its newly developed technology on Novel Primers for a PCR-RFLP assay for accurate identification of pathogenic mycobacteria at species level by gene amplification analysis which is very important for tuberculosis (TB) management in the country.

For this purpose, the ICMR, premier medical research organisation in the country, has invited proposals from the companies interested in commercialising the technology which has received an Indian Patent (No. 242073).

Senior officials in the ICMR said that there are several salient features to this technology which accurately identifies pathogenic mycobacteria by gene amplification analysis. The assay has been validated on reference strains as well as on Indian clinical and environmental isolates from different places of country deposited in the National Repository for Mycobacteria at the ICMR Institute.

It is used to differentiate pathogenic mycobacteria from non-pathogenic strains and it is used to differentiate pathogenic mycobacterial isolates at species level also. This assay allows better and easier differentiation on gels since the fragments generated from amplicons by this assay are bigger, which can be easily separated and analysed. Both slow growing and rapid growing mycobacteria could be well differentiated by using this technology.

Gene amplification of the 16S - 23S rRNA gene region is an in-house designed mycobacterial specific oligonucleotides primer(s) with optimized PCR conditions which yield a single fragment of approx 1.8 kb. Restriction analysis of 1.8 kb fragment by using the selected endonucleases Hha I, Hinf I and Rsa I yielded fragments of various lengths for different pathogenic disease causing species. Results indicated that this system is a simple, rapid and reproducible method to identify clinically relevant disease causing mycobacteria.

It is cost - effective and rapid method and found to be robust. The technology has been developed at laboratory scale. It can differentiate M. tuberculosis from M. avium, M. intracellulare, M. fortuitum, M. chelonae complex, M. terrae, M. vaccae, M. kansasi, M. flavescense, M. mrinum.

Officials said that the present technology relates to the rapid identification of the Pathogenic mycobacteria. More particularly, it relates to the development of new primers and a rapid method to identify the mycobacterial isolates at species level by gene amplification restriction analysis using primers encoding 16S-23S rDNA spacer region and flanking parts of the 16S as well as 23S rDNA.

Friday, December 21, 2012

Roche’s Rapid Mycoplasma Detection Test MycoTOOL Receives FDA Acceptance For Release Testing Of Biopharmaceutical Roche Product

First commercially available mycoplasma PCR test accepted by FDA reduces time for detection from one month to one day.

Today Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. It is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product that can replace conventional and time-consuming mycoplasma detection assays based on culture methods.

Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret.

“Mycoplasma contamination represents a significant issue during biological drug production,” said Ruedi Stoffel, Head of Custom Biotech at Roche. “Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products.”

On the occasion of the acceptance, an additional lecture about the MycoTool test was added to the agenda of the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Munich.

About the MycoTOOL PCR Mycoplasma Detection Kit

The MycoTOOL PCR Mycoplasma Detection Kit provides all critical reagents for performing an easy to use sample preparation and PCR. It offers a high sensitivity (<1 CFU/ml for most isolates) and is compatible with a diverse spectrum of sample types as cellular matrices (Human cells, primary and continuous), canine cells, nonhuman primate cells, many different rodent cell types and cell-free matrices (culture supernatants of CHO or human stem cells, egg derived samples). It detects the broad panel of Mollicute species too, including over 150 species due to universal primer design (e.g. Mycoplasma, Spiroplasma, and Acholeplasma).

The test also minimizes the risk of false negative and false positive test results: lysis controls of the matrix eliminate the risk of undetected intracellular Mycoplasma and positive controls verify potential PCR inhibition. Nucleic acid free reagents also prevent false positives and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.

Wednesday, December 19, 2012

NanoLogix Rapid TB Detection Results Published In Journal of Microbial & Biochemical Technology

An independent third-party study by one of the foremost Biomedical Research centers in the U.S. has demonstrated that NanoLogix's BioNanoPore (BNP) Ultra-Fast Identification Technology enables detection of live Tuberculosis cultures in five days as opposed to two+ weeks with traditional methods.

The peer reviewed study appears in the online edition of the Journal of Microbial & Biochemical Technology.

The authors conclude: "Ideally, highly accurate diagnostic tests for TB would be simple to perform, not require specialized equipment or facilities, provide rapid results for decreased time to treatment, are readily available, and cost-effective for the end user. These qualities are especially important in developing or high-TB burdened countries where the access and ability to purchase specialized equipment is limited, and number of trained personnel is low. The results of the present study demonstrate a proof-of-principal for BNP™ Middlebrook in detecting TB compared to the Middlebrook 7H10 reference test and should be considered as an ideal candidate for future evaluation of clinical samples."

Current rapid detection methods using PCR (molecular diagnostic) technology have a number of limitations in the fight against TB. They are unable to differentiate between live actual infection, and presence of dead bacteria in immune patients. Furthermore, PCR technology is very expensive, and needs specially trained personnel to perform testing, something not available, or even feasible, in the areas of the world most in need. Furthermore, even with PCR, the standard still requires culture positivity, which currently is a 3-4 week process. In addition, drug sensitivity is equally as important as identification, and early results using our BNF technology are extremely encouraging, taking only a few hours after bacterial identification.

Potential for the use of BNP technology is vast, said Bret T. Barnhizer, CEO of NanoLogix. "In addition to BNP's use in detecting many other bacteria, we see this technology as potentially providing both a standalone method for determining the presence of an actual TB infection and also a complementary method that can be used with either our BioNanoFilter (BNF) technology or molecular diagnostics methods for initial TB screening. We hope that our BNP rapid culture results will make it possible to finally monitor antibiotic treatment for TB in a close-to-real-time manner that is currently unavailable to practitioners. This ability could provide major assistance in the ongoing campaign to combat the scourge of Tuberculosis. We are committed to helping wipe out this horrible disease that takes over one million lives a year. As a partner in the Stop TB Alliance, we look forward to working further with them and WHO officials in a real effort to eradicate TB."

Mass., Israel Cooperate to Build Water Innovation Rapid Method

As Massachusetts eagerly seeks Israeli partners in water innovation, a Herzliya-based firm specializing in rapid microbiological water testing will get the chance to showcase its systems in the New England hi-tech hub.

Led by CEO Charles Gast, the TACount company was the winner among six finalists in the W.E.T. (Water Export Technology) Revolution Competition on Tuesday in Tel Aviv, organized by the Massachusetts Water Innovation Mission to Israel – a trade delegation of 48 industry executives.

The competition was a business opportunity for Israeli water technology firms to find a gateway to the North American market, as well as a networking event for innovators and investors on both sides.

Massachusetts’s interest in Israel really began in 2010, when a state survey showed that in 2009 nearly 100 Israeli companies were located in the state, contributing 6,000 jobs directly and 21,000 jobs indirectly, as well as generating $2.4 billion per year, explained Hadas Bar-Or, trade representative to Israel for the Commonwealth of Massachusetts.

Following the survey, Massachusetts Gov. Deval Patrick made a trip to Israel in 2011, and at the end of the year appointed Bar-Or to be the trade representative there.

“This is the only trade office Massachusetts has outside of Massachusetts,” Bar-Or said. “It goes to show how highly important the relationship is with Israel.”

For Jim Matheson, a partner at Flagship Ventures and president and CEO of Oasys Water in Massachusetts, Israeli and Massachusetts entrepreneurs are ideal cleantech partners. In addition to having many Israelis studying and working in the state, particularly in the Boston area, Matheson said that there is a “like-mindedness between New Englanders and Israelis,” a straightforward way of thinking.

“When the governor came here in March 2011 he got exposed to the world class water cluster based in Israel,” Matheson said. “He came back to Massachusetts and started to inquire what water resources are available there.”

For the past 18 months, representatives from the state’s water industry have been working on developing a similar type of cluster of resources.

“As a natural outcropping activity in formalizing activity and strengthening relationship it was a natural activity for us to come to Israel,” Matheson added.

Alicia Barton McDevitt, executive director and CEO of the Massachusetts Clean Energy Center (MassCEC), agreed that Israel is a “natural partner” for the US state.

“We have similar sized economies, have similar strengths, and that really is a focus on innovation and entrepreneurship, with life science, hi-tech, Internet, cleantech, water technology,” Barton McDevitt said. “We have natural linkages between our strengths each focusing on advanced research and innovation.”

MassCEC runs a joint program to fund Massachusetts and Israeli cleantech projects with Israel Industry, Labor and Trade Ministry chief scientist Avi Hasson and MATIMOP, the executive agency of Hasson’s office that generates international cooperation on and implementation of research and development programs.

The program, called Massachusetts- Israel Innovation Partnership (MIIP), recently announced the winners of its first round of funding, and will soon open a second round with $250,000 of funding from both sides.

As one of the largest challenges in the world is water scarcity, Barton McDevitt said she hoped that the two places could help pinpoint world-saving technologies together.

Meanwhile, Massachusetts is perfectly situated on the East Coast to be a “comfortable gateway to the US” for Israeli entrepreneurs, she added.

John Harthorne, co-founder and CEO of MassChallenge, the largest start-up accelerator in the world, was excited to be part of the mission in order to meet with potential Israeli candidates for participation in the accelerator. With an “overall mission to catalyze the startup renaissance,” MassChallenge takes 120 start-ups under its wing every year.

“There’s a very welcoming community for Israeli innovators in the Boston area,” Harthorne said. “We are eager to support more Israelis and strengthen that existing bond.”

To that effect, the accelerator will likely be launching an initiative called MassChallenge Israel toward the end of January, the first accelerator program designed for start-ups from a specific country, he explained.

Not only do Israelis tend to be well-educated and focused, but “because Israel is small all Israeli innovators are looking globally from day one,” Harthorne said.

From the Israeli side, a firm called Desalitech, which focuses on reverse osmosis processes for effluent treatment, used the event as an opportunity to announce that it would be launching its commercial and operational headquarters in Massachusetts.

“The State of Israel was welcomed so warmly there,” Desalitech CEO Nadav Efraty said.

As far as the competition goes, Gast – the CEO of TACount – stressed that “Massachusetts is a great hub for biotech,” and that he hopes to form strategic alliances there. As part of his win, he will get a week-long networking trip to the state to meet with potential investors and customers, and 20 hours worth of pro bono legal advice from Massachusetts and Israeli law firms.

“All of the types of companies we would be looking for have a presence there,” Gast said. “It’s a great opportunity to evaluate possibilities for R&D, sales and strategic alliances.”

Monday, December 17, 2012

Neogen Launches improved Rapid Test for Salmonella Enteritidis

Neogen Corporation has significantly improved its Reveal® rapid lateral flow test for Salmonella enterica serovar Enteritidis, and has launched the improved test as Reveal 2.0 for Salmonella Enteritidis.

The improved test for Salmonella Enteritidis (SE) provides results in only 10 minutes after a 48-hour sample enrichment. Unlike other rapid tests for SE, Reveal 2.0 for Salmonella Enteritidis follows the National Poultry Improvement Plan (NPIP) enrichment procedure which uses MSRV as the secondary enrichment. Using this protocol provides a significant time savings when confirming positive test results, as enriched samples can immediately be plated using the NPIP’s recommended cultural confirmation procedure.

“Continuous innovation for our broad range of rapid tests is a corporate commitment to our customers, and we are very pleased to launch this new and improved test that will both simplify SE detection and improve consistency of results,” said Gerry Broski, Neogen’s marketing director for Food Safety. “Reveal 2.0 for Salmonella Enteritidis enables the industry to get quicker results and provides the accurate answer they need to manage their flocks and egg production. Given the heightened concern for contaminated eggs, time is of the essence in the test and analysis workflow, and we are confident this new test will delight our customers with its speed and performance.”

In July, the U.S. Food and Drug Administration (FDA) implemented the last set of SE-reduction regulations that stemmed from the 2009 Egg Safety Rule. The rule requires shell egg producers to implement measures to prevent SE contamination during the production process, storage and transport.

Reveal 2.0 for Salmonella Enteritidis is initially validated for use in testing environmental drag swabs, and soon will expand to include eggs. A NPIP approval for the new Reveal 2.0 procedure is anticipated in 2013.

In a release, the FDA stated egg-associated illness caused by Salmonella is a serious public health problem. Infected individuals may suffer mild to severe gastrointestinal illness, short-term or chronic arthritis, or even death. Implementing the preventive measures is estimated to reduce the number of Salmonella Enteritidis infections from eggs by nearly 60 percent. Foodborne illness caused by SE typically occurs after eating raw, incompletely cooked, or contaminated eggs.

Neogen Corporation (Nasdaq: NEOG) develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets diagnostic test kits to detect foodborne bacteria, natural toxins, genetic modifications, food allergens, drug residues, plant diseases, and sanitation concerns, and dehydrated culture media.

Chembio Announces Oral Presentation at 2012 HIV Diagnostics Conference

Chembio Diagnostics, Inc., a leader in point-of-care diagnostic tests for infectious diseases, announces that an oral presentation and multiple poster presentations underscoring the clinical utility of the Company's Dual Path Platform(R) rapid, point-of-care (POC) diagnostic tests were presented at the 2012 HIV Diagnostics Conference held on December 12-14 at the Sheraton Atlanta Hotel.

An oral presentation entitled "Performance Evaluation of the DPP(R) HIV-SYPHILIS Assay: a novel, point-of-care rapid HIV 1/2, and Syphilis Treponema pallidum Antibody Combination Test" was delivered by Javan Esfandiari, Senior Vice President of Research and Development for Chembio. The presentation was made in conjunction with the "Testing for HIV/Hepatitis or HIV/Syphilis Co-infections" workshop moderated by Kelly Wroblewski, Association of Public Health Laboratories.

In his presentation on Wednesday, Mr. Esfandiari showcased the Company's DPP(R) HIV-SYPHILIS, a single-use immunochromatographic, rapid screening test for the detection of antibodies to HIV 1/2 and Syphilis Treponema pallidum in fingerstick whole blood, venous whole blood, serum or plasma. Data have shown the test to have accurate results with documented sensitivity and specificity for both HIV 1/2 and Syphilis antibodies on one device.

Mr. Esfandiari noted, "In the U.S., approximately 16% of patients, as well as 28% of men, who are infected with syphilis are also co-infected with HIV. As a result, there is growing interest in an accurate, rapid POC test that can diagnose both HIV and syphilis antibodies. Moreover, syphilis facilitates HIV transmission, making an early and accurate syphilis diagnosis key to preventing continued transmission of both diseases. DPP(R) HIV-SYPHILIS requires minimal patient sample and provides actionable results in 20 minutes, allowing for results and counseling at the point-of-care. Based on the market need and the strength of these data, we intend to work with the regulatory authorities to establish a pathway to approval for this much-needed diagnostic."

"We are delighted to have this solid body of clinical data presented at the 2012 HIV Diagnostics Conference including the outstanding performance of our HIV 1/2 test that is pending approval ," stated Lawrence Siebert, Chembio's Chief Executive Officer. "These data confirm the high sensitivity and specificity of our DPP(R) rapid assays in patients with HIV and HIV-related infectious diseases. The simultaneous detection of multiple antibodies offers the opportunity to increase diagnosis of and treatment for these highly infectious diseases, which is hoped to reduce their transmission. As a result, there continues to be a substantial interest in these products by public health groups in the U.S. and abroad."

3M Molecular Detection Assay Salmonella Certified by AFNOR Certification

3M Food Safety announced its 3M™ Molecular Detection Assay Salmonella received an NF VALIDATION mark from AFNOR Certification. The Salmonella assay was among three pathogen test kits the company introduced alongside its novel 3M™ Molecular Detection System less than a year ago. In April, AOAC Research Institute granted PTM SM certification of the Salmonella assay, another important confirmation of the technology's effectiveness in detecting the bacteria. "Salmonella has been responsible for multiple foodborne illness outbreaks in the U.S. as well as Europe this past year, so being able to offer such a simple and rapid assay for that pathogen that stands up to the rigor of AFNOR Certification criteria is a key development for food processors based throughout the world," said Marie-Pierre Copin, 3M Food Safety's European regulatory affairs specialist.

The 3M Molecular Detection System and its assays provide food processing businesses, third-party laboratories, universities and government agencies a rapid, qualitative method to easily and accurately detect pathogens in enriched food and food process samples. Designed with early input from 3M's worldwide clientele, the system and its assays have already been sold in 33 countries. The system targets and amplifies nucleic acid in enriched samples through a unique combination of isothermal DNA amplification and bioluminescence detection technologies.

To obtain NF VALIDATION certification for egg, meat and dairy food products (excluding milk powders), performances of the 3M Molecular Detection Assay Salmonella for those products were validated in comparison with results of the ISO 6579 worldwide standard for detecting Salmonella spp. The NF VALIDATION study was done according to ISO 16140 standard. An expert laboratory initially confirmed the technology's effectiveness versus the reference method. Subsequently, 18 different labs spanning seven countries conducted collaborative testing to confirm method robustness. Additional NF VALIDATION studies of the Salmonella assay on seafood and vegetables as well as processing environment samples are anticipated in 2013.

"We're proud to offer this important international validation to our worldwide clients," said Niki Montgomery, 3M Food Safety global marketing manager. "It's a big milestone in our continued effort to systematically chart the path toward comprehensive scientific validation."

Apollo First to Install Automated Microbial Identification System in India

Indraprastha Apollo Hospitals, New Delhi, installed a first-of-its-kind cutting edge technology bioMerieux's MALDI-TOF-VITEK® MS system in India - a rapidly automated microbial identification system that identifies disease-causing microorganisms such as bacteria and fungi so that correct diagnosis and early treatment is achieved.

Dr. Raman Sardana , Senior Consultant (Microbiology) & Additional Director - Medical Services, Apollo Hospitals Group said, "Over the past decade, new technologies and automated solutions have greatly reduced the amount of time it takes to provide doctors with actionable results in managing infection. The speed of diagnostic laboratory results has a critical impact on curbing the increasing antimicrobial resistance. The rapid identification of microorganisms has been shown to help guide patient treatment and improve clinical outcomes. Waiting several days for a definitive identification of the pathogen provides an obstacle to the clinician seeking to target therapy with the most effective treatment. This is where technologies such as MALDI-TOF-VITEK MS are helpful with their accuracy and specificity."

With the help of MALDI-TOF-VITEK MS, the type of infection or infections present can be speedily determined, allowing doctors to more specifically target their therapies with the right antimicrobial at the right dosage. This plays an important role in preventing and slowing the emergence of resistant bacteria and fungi which is a much-wanted need in the world today. In the coming months identification of all microbes including virus would be a possibility.

About MALDI-TOF MS (Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry)

Mass Spectrometry (MS) is a technique used to screen simultaneously a multitude of molecules and determine the identity of microbes by exciting them with laser and analysing their protein pattern by analysing their individual mass-to-charge ratio. These molecular "signatures" can be used for rapid bacterial and fungal identification (ID) from isolated colonies. MALDI-TOF-VITEK MS is based on Matrix-assisted laser desorption/ionization -time-of-flight mass spectrometry (MALDI-TOF MS) - one of the latest and most promising technologies, producing results in a matter of few minutes rather than days as it happens currently.

The biggest payoff comes to the patients and clinicians with huge reduction in the time it takes to identify organisms. This technology assists clinicians dealing with infectious diseases in facing the ever-increasing number of potentially pathogenic species of bacteria and fungi in fluxed into clinical significance.

Tuesday, December 11, 2012

PathoGenetix Names Ann Merrifield as Chief Executive Officer and Prepares to Launch Unique Bacterial Identification Technology

PathoGenetix, Inc., a commercial-stage developer of an automated system for rapid identification and typing of bacteria strains, announced that Ann Merrifield has joined the company as President and CEO. Ms. Merrifield takes the lead as PathoGenetix prepares to launch the first commercial system of its proprietary Genome Sequence Scanning (GSS) technology for food safety testing and outbreak investigation. PathoGenetix will provide its automated, benchtop technology to food industry and government customers beginning in 2013.

Ms. Merrifield has spent much of her career leading the development of high growth, profitable biotechnology businesses in biologics, diagnostic services and devices. Prior to PathoGenetix, Ms. Merrifield spent 18 years at Genzyme Corporation, a diversified, global biotechnology company, where she served as President of both the Genzyme Biosurgery and Genzyme Genetics businesses. Prior to Genzyme, Ms. Merrifield was a partner with Bain & Company, Inc.

“Ann Merrifield is the ideal leader to set direction, drive commercialization and develop partnerships for PathoGenetix as we transition from technology development to commercial application of Genome Sequence Scanning,” said PathoGenetix board member, Steve Gullans, Ph.D. “Ann’s success in ramping revenues for revolutionary scientific products is a perfect match for PathoGenetix at this stage.” Dr. Gullans is a co-founder and partner at Excel Venture Management, and was a faculty member at Harvard Medical School and Brigham and Women's Hospital for nearly 20 years.

Originally developed to identify microbial bioterrorism threats, Genome Sequence Scanning is a breakthrough in bacterial identification technology that offers new levels of speed, automation and accuracy for food safety testing and public health investigations of foodborne pathogen outbreaks. The market for effective pathogen confirmation and identification tools for outbreak investigations is estimated at $250 million, and is growing at greater than 10% per year.

“Genome Sequence Scanning is an innovative and powerful new platform for bacterial identification and typing,” Ms. Merrifield said. “I look forward to working with the talented team at PathoGenetix to bring the significant benefits of GSS into the food safety market." When a pathogen is detected in a food production facility—or worse, is making people sick in multiple locations or states—an investigation is undertaken to identify the organism and trace it back to its source. Current identification systems require time-consuming sample preparation to isolate the bacteria, followed by complex protocols that often produce inconsistent results, even when run by the most skilled operators.

In just four hours, Genome Sequence Scanning extracts microbial DNA from enriched food or clinical samples to confirm and characterize foodborne pathogens. The strain information provided is comparable to pulsed field gel electrophoresis (PFGE), the current gold standard for food pathogen outbreak investigations. Yet because GSS does not require a cultured isolate, it is compatible with sample preparation protocols that are often used with the newer, rapid detection methods that are increasingly in use in clinical and food safety testing laboratories. Its automated platform and simplified protocol require minimal training and ensure consistent, accurate results.

Positive Data From Independent Study of Chembio Diagnostics' Rapid, Point-of-Care Syphilis Test Published in Clinical Infectious Diseases

Chembio Diagnostics, Inc., a leader in point-of-care diagnostic tests for infectious diseases, reported that data from a study evaluating performance characteristics (sensitivity and specificity) of the Company's patented Dual Path Platform (DPP(R)) rapid point-of-care (POC) test for syphilis was recently published online in Clinical Infectious Diseases and is expected to be published in the upcoming print edition. DPP(R) Syphilis Screen and Confirm is the first dual non-treponemal (screen for infection) and treponemal (confirms an active syphilis infection if non-treponemal is reactive) POC syphilis test that permits the simultaneous yet separate detection of both markers at the POC. The study authors concluded that DPP(R) Syphilis Screen and Confirm demonstrated good sensitivity and specificity in detecting treponemal and non-treponemal antibodies in three kinds of blood specimens. The complete article, "A dual point-of-care test shows good performance in simultaneously detecting nontreponemal and treponemal antibodies in patients with syphilis -- A multi-site evaluation study in China," can be accessed online at http://cid.oxfordjournals.org/content/early/2012/10/29/cid.cis928.abstract.

The study was supported by a grant from the Rapid Syphilis Test Introduction Project (UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases A70577 through a grant from the Bill & Melinda Gates Foundation).

Lawrence Siebert, Chembio's Chief Executive Officer, noted, "These data independently confirm the high sensitivity and specificity of our DPP(R) Syphilis Screen and Confirm rapid assay in patients with syphilis. The simultaneous detection of treponemal and non-treponemal antibodies offers the opportunity to increase coverage of syphilis screening and treatment. Currently, there is no single FDA-approved point-of-care test for syphilis that differentiates between active and past, or previously treated cases, and there continues to be a substantial interest in this product by public health groups in the United States and abroad."

According to the U.S. Centers for Disease Control and Prevention (CDC), "The use of only one type of serologic test is insufficient for diagnosis because each type of test has limitations, including the possibility of false-positive test results in persons without syphilis. False-positive nontreponemal test results can be associated with various medical conditions unrelated to syphilis, including autoimmune conditions, older age and injection-drug use; therefore, persons with a reactive nontreponemal test should receive a treponemal test to confirm the diagnosis of syphilis."

Mr. Siebert added, "We believe these positive data will be helpful in supporting our U.S. regulatory filing for DPP Syphilis Screen and Confirm, for which we are pursuing a de novo 510(k) regulatory pathway with the U.S. Food and Drug Administration (FDA). We are in discussion with the FDA to review these and other data and then to re-initiate clinical trials and submit our application by the middle of 2013."

According to the CDC, syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum. Syphilis can cause long-term complications and/or death if not adequately treated. In 2010 there were 45,834 new cases of syphilis in the U.S., of which, 13,774 were primary and secondary syphilis, the earliest and most transmissible stages of syphilis. The World Health Organization estimated that 11 million new cases of syphilis occurred in adults in 2005, the majority of them in developing countries.

Bruker Announces Multiple Placements of MALDI Biotyper Systems with Various German Federal, State and Local Governmental Authorities

Bruker today announces multiple placements of MALDI Biotyper systems for rapid, differentiated and cost-effective microbial identification with various local, state and federal authorities and institutes in Germany. These local authorities are responsible for public health, animal health, food safety, consumer protection, agriculture and fisheries.

In recent years, European clinical laboratories have been increasingly performing routine microbial identification using MALDI-TOF mass spectrometry. In contrast to previous biochemical testing methods, the MALDI Biotyper offers the benefit of very fast identification with results available in a few minutes starting from a culture plate. Additionally, the MALDI Biotyper reference library has broader coverage of microbial species as compared to commercially available biochemical methods and is applicable for isolates obtained from food safety and consumer protection sources. Frequently, isolates from these sources are not sufficiently represented in previous commercial identification systems.

Microbial identification with the MALDI Biotyper is done using a proteomic fingerprint. This unique species-specific pattern is automatically compared with proteomic fingerprints of reference spectra from more than 2100 species in the MALDI Bioptyper library. In addition, the MALDI Biotyper supports the Open Microbiology Concept which allows customers to generate their own entries from their own regional isolates via a push-button process and storage in a customer-specific sub-library. Among recent new MALDI Biotyper customers are state and local authorities in Baden-Wurttemberg ( www.ua-bw.de ), Stuttgart (CVUA Stuttgart), Karlsruhe (CVUA Karlsruhe), Freiburg (CVUA Freiburg) and Aulendorf (STUA Aulendorf). Additional orders were received from authorities in Arnsberg (STUA Arnsberg), Rostock (LALLF Rostock, www.lallf.de ) and Bad Langensalza ( www.thueringen.de/de/tllv ). Previously, authorities in Oldenburg ( www.laves.niedersachsen.de ), Krefeld (CVUA Krefeld) and Oberschleissheim ( www.lgl.bayern.de ) have implemented the MALDI Biotyper workflow.

Recently, the Federal Institute for Risk Assessment (Bundesinstitut fur Risikobewertung, Berlin, www.bfr.bund.de ) and the Industry Control Office Hildesheim ( www.gewerbeaufsicht.niedersachsen.de ) have also chosen the MALDI Biotyper. As a result, a wide range of German state and local authorities, regulatory bodies and federal control institutes now rely on Bruker's MALDI Biotyper solution for their microbial identification requirements. Bruker complies with ISO 9001 and ISO 13485 requirements for quality management in its MALDI Biotyper production facilities in Bremen (Germany) and in Billerica, Massachusetts (USA) in compliance with the strict quality assurance requirements of this customer group.

Dr. Jorg Rau at the CVUA Stuttgart commented: "In our laboratory we have utilized Bruker's FT-IR spectroscopy instruments for a number of years. We see a general trend that such modern physical techniques increasingly replace outdated biochemical testing. Accordingly, it was a logical step to introduce also a MALDI-TOF MS based workflow with the MALDI Biotyper in our laboratory for broad identification and typing purposes to complement the FT-IR spectrometer. It is especially helpful that the MALDI Biotyper reference library is an open system, where we can add our own isolates, if needed. We can even exchange these new entries between our cooperating laboratory sites in Baden-Wurttemberg."

Dr. Wolfgang Pusch, Executive Vice President - Microbiology Business at Bruker Daltonics, added: "We are pleased that these authorities involved in consumer protection, food safety and risk assessment have selected the MALDI Biotyper for their microbiology labs. This clearly indicates that the Bruker MALDI Biotyper is setting new standards for high-quality, rapid and cost-effective methods for microbial identification for these laboratories. We see food safety testing as one of the additional broad application fields for our MALDI Biotyper systems."

Thursday, December 6, 2012

Abbott Discontinuing Current Version of Plex-ID PCR System for Smaller Platform Under Development

Abbott is discontinuing the current version of the Plex-ID system as it prepares for market a next-generation system intended to be smaller and easier to use, and thus more conducive to a clinical diagnostics setting.

Abbott's Plex-ID system is based on technology that the company acquired along with Ibis Biosciences in 2009. The platform combines automated sample preparation, broad PCR amplification, and electrospray ionization mass spectrometry of DNA amplicons to identify base composition based on molecular weight. The company generally refers to the core underlying technology as PCR/ESI-MS.

In general, the system can be used to screen and identify bacteria, viruses, fungi, and protozoa by comparing assay results to a library of more than 750,000 entries; perform high-resolution subtyping; identify known virulence markers and antibiotic resistance genes; and identify mixtures of microbes direct from a single sample.

According to the company's website, Plex-ID can analyze as many as 250 samples per day and can produce results within 8 hours, from sample preparation to identification.

Both Ibis and Abbott had early success selling the platform into applied markets, such as biodefense, but in recent months the company and its collaborators have published multiple peer-reviewed studies and presented at scientific conferences on the clinical diagnostic potential of Plex-ID.

For instance, in April at Cambridge Healthtech Institute's "Innovative Sample Prep & Target Enrichment in Clinical Diagnostics" in Newport Beach, Calif., Mark Eshoo, director of new technology development at Abbott, disclosed that the company was working on a Plex-ID assay to detect and genotype Borrelia burgdorferi, the bacterium responsible for causing Lyme disease in humans.

And in August, researchers from Johns Hopkins University reported that their high-resolution melting assay and a Plex-ID assay performed similarly in identifying pathogens from a cohort of positive blood culture samples — with the Plex-ID scoring particularly high marks in terms of throughput, automation, and sensitivity.

In addition, in March Abbott and Dallas-based Genetics Laboratory said they were co-developing a molecular test designed to rapidly detect microorganisms that cause orthopedic infections.

Abbott in April received CE marking in the European Union to market its Plex-ID platform along with three assays: Plex-ID Viral IC Spectrum, Plex-ID BAC Spectrum BC, and Plex-ID Flu.

And, in addition to the BAC Detection and Broad Fungal assays used in the aforementioned studies, Abbott offers a variety of Plex-ID assays for microbial identification for research use only, including tests for biothreats, Clostridium difficile, food-borne illnesses, methicillin-resistant Staphylococcus aureus, and multi-drug resistant tuberculosis.

During his presentation at the CHI conference in April, Abbott's Eshoo indicated that the company was at least looking into seeking approval from the US Food and Drug Administration for Plex-ID.

However, this week Abbott confirmed that it is planning to discontinue the current version of Plex-ID in favor of a next-generation system that would be more conducive to clinical implementation. The current Plex-ID platform has been reported by users to cost in the range of $750,000, and the instrument is about the size of a large refrigerator, making it ill-suited for use in most clinical diagnostic laboratories.

An Abbott spokesperson confirmed that the company was developing a next-generation version of Plex-ID, but did not elaborate. It is unclear whether Abbott will discontinue the current platform in both Europe and the US; or whether the company plans to seek FDA approval for a newer version of the system.

Wednesday, December 5, 2012

The MIT-1000 Will Showcase at Malaysian Microbiology Symposium

Micro Imaging Technology, Inc. announced a collaboration with Biotek Sdn. Bhd., to exhibit the MIT-1000 rapid microbial identification system, at the 31st Symposium of the Malaysian Society for Microbiology. The symposium will be held in Kota Kinabalu, Sabah, Malaysia from December 13 through the 15th this year and will address contemporary topics on microbiology from both national and regional perspectives.

The Malaysian Society for Microbiology is one of the oldest Societies in Malaysia. It was established forty years ago and today, remains one of the oldest and largest life science membership organizations with members from over 20 disciplines of microbiological specialization such as infectious diseases and agro-disease control, among other areas. "We were pleased to have Biotek MALAYSIA and Dr. LC Chai from University of Malaya visit our facility last month and thrilled when asked to team up to unveil the MIT-1000 at this year's event," stated Jeff Nunez, President and CEO of Micro Imaging Technology, Inc. "Biotek came on board as our Malaysian and our ASEAN distributor in 2009 and had purchased an MIT-1000 Demo System. The System was recently upgraded to the new MIT-1000 commercial system standard which will be showcased. Biotek has an excellent track record in sales, marketing and distribution of scientific products in microbiology and life science in ASEAN countries. They will do real justice to spreading the word on our breakthrough technology in this forum," Nunez continued.

The MIT-1000 is a stand-alone, optically-based, software driven system that can detect pathogenic bacteria and complete an identification test in less than five (5) minutes for pennies per test. According to MIT's Chief Scientist, David Haavig, PhD, "In the US alone, around 76 million cases of food-borne illnesses, resulting in 325,000 hospitalizations and 5,000 deaths, are estimated to occur each year. The leading cause of these illnesses and deaths are three main strains of bacteria: E. coli, Salmonella, and Listeria. Rapid identification of these disease-causing pathogens in food is critical to the health and safety of all consumers."

Sunday, December 2, 2012

MedMira Files Pre-IDE with FDA for New Rapid HIV Test to Meet Demand for Increased Routine Screening in the US

MedMira Inc., (MedMira), a developer of rapid diagnostic technology and solutions, commends the U.S. Preventive Services Task Force (USPSTF) on its new guidelines calling for routine HIV screening of all people aged 15-65 and all pregnant women in the United States during the normal course of medical care.

The new guidelines will significantly increase the number of people being screened for HIV, as previous recommendations and insurance policies only covered routine testing for individuals considered at high risk. According to the US Centers for Disease Control and Prevention (CDC), approximately 1 in 5 of the 1.2 million people in the US living with HIV do not know that they are infected. The new recommendations, which are available until December 17, 2012 for public comment, are in line with the CDC's recommendations for routine HIV testing for people 13 years of age or older.

"We believe that the USPSTF's new recommendations on routine HIV testing will have a significant influence on the early treatment of those individuals unaware of their HIV infection, as well as preventing the further spread of the disease," said Hermes Chan, CEO, MedMira Inc. "As HIV testing becomes part of routine visits to doctor's offices and convenience care clinics, we expect to see an increased demand for high quality, efficient, rapid tests designed for use at the point-of-care. With this in mind, we are bringing a whole blood version of our Reveal G3 rapid HIV test to US healthcare providers. Our technology enables a 3 minute procedure and instant results for HIV screening, and a highly cost-effective diagnostic tool for healthcare providers and their patients."

Earlier this month, MedMira submitted a pre-IDE (Investigational Device Exemption) information package to the U.S. Food and Drug Administration (FDA) for a whole blood rapid HIV test. The Company currently sells its Reveal G3 Rapid HIV-1 Antibody Test in the US for use in laboratories and hospitals. The new version will be aimed at physician offices, convenience care clinics, mobile testing, and large scale public health programs where whole blood specimens are preferred and much of the new routine HIV screening will take place.

The USPSTF is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence-based recommendations about clinical preventative services, such as screenings, counseling services, and preventative medications. USPSTF recommendations have formed the basis of the clinical standards for many professional societies, health organizations, and medical quality review groups.

MedMira is a leading developer and manufacturer of flow-through rapid diagnostics and technologies. MedMira is the only Canadian company to be awarded US Army contracts for the development of rapid tests for HIV and Hepatitis viruses. The Company's testing solutions provide hospitals, labs, clinics and individuals with reliable, rapid diagnosis for diseases such as HIV and hepatitis C in just three minutes. The Company's tests are sold under the Reveal®, Multiplo™ and Miriad brands in global markets.

Saturday, December 1, 2012

Danish Researchers Develop Rapid Malaria Test That Detects All Human Strains

A new rapid diagnostic test for all five strains of Plasmodium species that infects humans has been developed by a team led by Denmark scientists, according to a Aarhus University news release Nov. 27.

The article, recently published in the journal ACS Nano, describes the new technology that is designed to the very useful in field conditions where specially trained personnel, expensive equipment, clean water or electricity may be unavailable.

The highly sensitive technology, called REEAD (Rolling Circle-Enhanced Enzyme Activity Detection), makes it possible to diagnose malaria from a single drop of blood or saliva, according to researchers.

According to the release, the researchers say the REEAD technology is based on measuring the activity of an enzyme called topoisomerase I from the Plasmodium parasite.

Combined with a droplet microfluidics lab-on-a-chip platform, this design allowed for sensitive, specific, and quantitative detection of Plasmodium species in single drops of unprocessed blood with a detection limit of less than one parasite/μL.

In addition, the methodology allows the use of the non-invasive sample, saliva, to detect Plasmodium parasites.

A feature of the REEAD technology, according to researchers, includes the ability to detect strains of Plasmodium that other rapid procedures cannot, such as P. vivax and P. knowlesi.

Department of Molecular Biology and Genetics, Aarhus University, Denmark professor, Birgitta Knudsen said, “This combination of molecular biologists, doctors, engineers and statisticians has been important for our success in developing the new method.”

According to the World Health Organization (WHO), there were about 216 million cases of the mosquito borne malaria (with an uncertainty range of 149 million to 274 million) and an estimated 655,000 deaths in 2010 (with an uncertainty range of 537,000 to 907,000).

Malaria mortality rates have fallen by more than 25% globally since 2000 and by 33% in the WHO African Region. Most deaths occur among children living in Africa where a child dies every minute from malaria.

Malaria is caused by Plasmodium parasites. The parasites are spread to people through the bites of infected Anopheles mosquitoes, called "malaria vectors", which bite mainly between dusk and dawn.

There are four parasite species that cause malaria in humans: Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae and Plasmodium ovale.

Plasmodium falciparum and Plasmodium vivax are the most common. Plasmodium falciparum is the most deadly.

In recent years, some human cases of malaria have also occurred with Plasmodium knowlesi – a species that causes malaria among monkeys and occurs in certain forested areas of South-East Asia.

US Announces $11M in Additional Support for Rapid TB Test in 14 Countries

The United States President’s Emergency Plan for AIDS Relief (PEPFAR) announced Tuesday an additional $11 million to provide up to 150 Xpert® MTB/RIF instruments and 450,000 test cartridges in 14 high-burden countries across sub-Saharan Africa and in Burma. 

The Cepheid Xpert® MTB/RIF assay is a new fully automated molecular diagnostic test for tuberculosis disease (TB). It can detect Mycobacterium tuberculosis DNA and mutations associated with rifampicin resistance directly from sputum specimens in less than 2 hours. The assay is more sensitive for detecting TB than sputum-smear microscopy with similar accuracy as culture on solid media. The ability of the Xpert assay to detect smear-negative TB provides a significant advantage over smear microscopy, especially for persons with TB who are also HIV-infected. 

This support, to be implemented through USAID and CDC, will accelerate access to Xpert® MTB/RIF in countries with a high burden of TB/HIV co-infection. Additionally, a portion of this funding will train health workers on proper application of the device and support ministries of health to integrate its usage into national laboratory strategies. 

TB is the leading cause of death among people living with HIV in Africa and greater access to this test offers a significant advance in the capacity of TB and HIV programs to diagnose TB quickly and help reduce TB transmission, the development of TB disease, and avoidable deaths. 

The announcement comes on the heels of the November 29 launch of the PEPFAR Blueprint for an AIDS-free generation and in conjunction with the 1st annual meeting of the African Society of Laboratory Medicine in South Africa. The PEPFAR Blueprint, a document outlining America’s specific action steps toward creating an AIDS-free generation, highlights the importance of smart investments that save lives and using science to inform programming. PEPFAR’s ongoing support for roll out of Xpert® MTB/RIF is one such smart investment. 

U.S. Global AIDS Coordinator Ambassador Eric Goosby said, “The roll out of Xpert® MTB/RIF has brought us to the cusp of a revolution in TB diagnosis. As a clinician, I am thrilled about the promise of this technology to bring a rapid diagnostic closer to patients. Tackling TB/HIV co-infection is a high priority for PEPFAR and this funding plus up for Xpert® MTB/RIF reflects that commitment.”

The additional resources announced today bring PEPFAR’s investments to-date in Xpert® MTB/RIF to more than 275 instruments in high-burden countries. Additionally, in August 2012, PEPFAR and USAID partnered with UNITAID and the Bill & Melinda Gates Foundation in an innovative public-private partnership to reduce the cost of Xpert® MTB/RIF cartridges by 40% (from $16.86 to $9.98). This partnership also significantly accelerates access to this cutting-edge technology.