FDA Grants Quest Diagnostics Simplexa 2009 H1N1 Test 501(k) Clearance

Quest Diagnostics Inc has announced that the FDA has issued 510(k) clearance to the Simplexa™ Influenza A H1N1 (2009) test on the 3M™ integrated cycler. The Simplexa test, developed and manufactured by Quest Diagnostics’ Focus Diagnostics business, is the first to be cleared by the FDA for use as an aid in the detection and differentiation of influenza A and 2009 H1N1 influenza viral RNA.

The Simplexa Influenza A H1N1 (2009) test runs on the 3M Integrated Cycler under an exclusive global distribution agreement between Focus Diagnostics and 3M. The test employs real-time reverse transcription (RT) polymerase chain reaction (PCR) to qualitatively detect RNA of the 2009 H1N1 flu virus (2009 H1N1) in a patient’s nasal or nasopharyngeal specimens. It reports if a specimen is positive or negative for the presence of 2009 H1N1 or influenza A virus. By comparison, some flu tests, including rapid point-of-care influenza tests, can detect the presence of influenza A, but not differentiate the presence of 2009 H1N1. In addition to 2009 H1N1, influenza A viruses include some seasonal flu subtypes.

“Innovation often emerges in response to crisis, and the 2009 H1N1 is no exception,” said John G. Hurrell, PhD, vice president and general manager, Focus Diagnostics. “When 2009 H1N1 surfaced about a year ago, limitations in traditional flu tests made them unsuitable for dealing with a virus infecting large swaths of the population. These limitations included the sensitivity of rapid tests and the need to ship samples to reference labs with reliable PCR methods. We designed our Simplexa 2009 H1N1 test to overcome these problems by bridging highly reliable PCR with testing technologies that many hospital labs can perform in-house.”

“Moreover, FDA clearance of our Simplexa test means hospital and other labs can use our test with confidence since it meets regulatory requirements long term, unlike flu tests authorized for 2009 H1N1 emergency use testing until late June,” Hurrell added.

Source: Quest Diagnostics

Low-Cost, Ultra-Fast DNA Sequencing Brings Diagnostic Use Closer

Sequencing DNA could get a lot faster and cheaper—and thus closer to routine use in clinical diagnostics—thanks to a new method developed by a research team based at Boston University. The team has demonstrated the first use of solid-state nanopores—tiny holes in silicon chips that detect DNA molecules as they pass through the pore—to read the identity of the four nucleotides that encode each DNA molecule. In addition, the researchers have shown the viability of a novel, more efficient method to detect single DNA molecules in nanopores.

“We have employed, for the first time, an optically based method for DNA sequence readout combined with the nanopore system,” said Boston University biomedical engineer Amit Meller, who collaborated with other researchers at Boston University and at the University of Massachusetts Medical School in Worcester. “This allows us to probe multiple pores simultaneously using a single fast digital camera. Thus, our method can be scaled up vastly, allowing us to obtain unprecedented DNA sequencing throughput.”

“This puts us in the unique advantageous position of being able to claim that our sequencing method is as fast as the rapidly evolving photographic technologies,” Meller said. “We currently have the capability of reading out about 200 bases per second, which is already much faster than other commercial third-generation methods. This is only the starting point for us, and we expect to increase this rate by up to a factor of four in the next year.” Licensing intellectual property from Boston University and Harvard University, Meller and his collaborators recently founded NobleGen Biosciences to develop and commercialize nanopore sequencing based on the new method. “I believe that it will take 3 to 5 years to bring cheap DNA sequencing to the medical marketplace, assuming an aggressive research and development program is in place,” Meller said.

Source: Boston University School of Engineering

Bio-Rad Launches MMRV IgG Kit for BioPlex 2200 System

Bio-Rad Laboratories announced the launch of the BioPlex® 2200 MMRV IgG kit for use on the company’s BioPlex 2200 system. The MMRV IgG kit (measles; mumps; rubella; and the varicella-zoster virus, commonly known as chicken pox) provides simultaneous results for the four tests that are commonly ordered together to determine a patient’s susceptibility to MMRV.

The BioPlex 2200 MMRV IgG kit offers the advantage of multiplexing to deliver test results from a single patient sample. As a result, labs are able to generate test results quickly and with less effort. MMRV are infectious diseases that are preventable through vaccination. Maintaining high vaccination coverage and providing MMRV IgG results when an individual’s status is uncertain is the most effective way to prevent disease outbreaks. Employees in health care facilities and military personnel, among others, are typically screened for MMRV IgG to ensure their safety.

“With the introduction of the BioPlex 2200 MMRV IgG kit, Bio-Rad offers a compelling menu for infectious disease serology and autoimmune testing laboratories,” said John Goetz, Bio-Rad vice president and group manager clinical diagnostics. “The MMRV IgG kit is the latest in our expanding menu of assays that run on our BioPlex 2200 system.”

Source: Bio-Rad Laboratories

Molecular Diagnostic Experts Identify Keys to Continued Growth

The 2010 Molecular Diagnostics conference faculty of thought leaders isolated the drivers and unique challenges of the fastest-growing segment of the $55 billion clinical laboratory industry. During the 3-day event, hundreds of professionals from across the spectrum of molecular diagnostics expertise listened in as the industry’s future was detailed from a variety of perspectives.

Presented by Washington G-2 Reports, the event identified the key trends that are likely to impact the business strategies of clinical labs that perform molecular diagnostic testing, both long and short term, including:

  • A call from within the industry to expand awareness of and regulatory attention to diagnostics generally and molecular diagnostics in particular, from Mara Aspinall, president and CEO of next-generation diagnostics firm On-Q-ity.
  • Projections of robust growth (approximately 12% CAGR) in molecular diagnostics as tests are increasingly commercialized, new clinical laboratories enter the field, and health care reform requires insurers to implement and reimburse for screening, prevention, and wellness measures as identified by Stephanie Murg, editor, Washington G-2’s Diagnostic Testing & Technology Report.
  • The need to accelerate efforts to standardize and “curate” genomic data with the goal of making it more clinically relevant and actionable, as highlighted by George Church, founder of the Personal Genome Project, professor of genetics, Harvard Medical School, and director, Center for Computational Genetics.
  • The prediction that the legality of gene patents will ultimately be decided by the Supreme Court.

Source: Washington G-2 Reports

Biocare Launches New Chromogenic ISH Technology

Biocare Medical announces the launch of RISH™, a new chromogenic ISH technology reducing protocol length from 2 days to approximately 2.5 hours. In a simplified protocol the company has removed the need for RNase free solutions and labware, the overnight hybridization, and harsh stringent wash conditions. The proprietary DNA probe technology ensures high specificity and accuracy for the target.

The result: virtually no background and a clean chromogenic signal. Users can visualize the target under brightfield microscopy, along with the tissue morphology on a single slide. This five-step procedure is as simple as IHC—helping to bring what was once considered a tedious technology to every lab.

The company will be launching with a small subset of probes initially. These RISH™ Probes are designed for the diagnosis and classification of hematopoietic and lymphoid neoplasms: EBER, Kappa, and Lambda Light Chain.

Source: Biocare Medical