December 2009 Clinical Laboratory News: News from the FDA

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December 2009: Volume 35, Number 12

FDA Publishes Guidance on H1N1 Diagnostics Tests

FDA published a guidance document intended to help manufacturers develop diagnostics tests and submit requests for emergency use authorizations (EUAs) for the 2009 H1N1 influenza virus. Currently, no FDA approved or cleared tests are available to diagnose this strain of flu virus. EUAs allow authorized tests to be used during declared public health emergencies. The guidance document contains information the FDA recommends be included in EUA requests. A full copy of the guidance is available online. Search for UCM188679.

FDA Grants Second Authorization for Focus Diagnostics’ H1N1 Test

FDA issued a second emergency use authorization (EUA) to Focus Diagnostics for its 2009 H1N1 influenza virus test. The new EUA authorizes Focus Diagnostics to market its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler to CLIA high-complexity laboratories for the duration of the emergency. With this EUA, Focus Diagnostics is the only company in the U.S. to offer test kits for detecting the 2009 H1N1 virus authorized by FDA for use in CLIA high-complexity labs. The Simplexa Influenza A H1N1 (2009) test uses real-time PCR to qualitatively detect RNA of the 2009 H1N1 flu virus in nasal or nasopharyngeal specimens. The test detects a specific region of the hemagglutinin gene of the 2009 H1N1 influenza virus to differentiate samples from seasonal human influenza A virus.

Gen-Probe Granted FDA EUA for Flu Test

Gen-Probe was granted an FDA emergency use authorization (EUA) for its Prodesse ProFlu-ST test to be used in CLIA high-complexity labs for diagnosis of the 2009 H1N1 influenza virus. Aided by an algorithm that relies on seasonal A/H1 virus and seasonal influenza A/H3 virus results, ProFlu-ST is the first commercially available RT-PCR test that can identify the H1N1 virus from a single sample. Because the three influenza A subtypes have different susceptibilities to antiviral drugs, the capability to distinguish among viruses is important for clinicians and patients this flu season. The EUA will remain in place for the duration of the declared public health emergency.

Response Biomedical Cleared to Add Analytical Reactivity Info to Assay

Response Biomedical received a special 510(k) FDA clearance for an update to the company’s RAMP Influenza A/B Assay package insert to include analytical reactivity information for a strain of the 2009 H1N1 virus. Although the assay has shown the ability to detect the 2009 H1N1 virus in cultured isolates, the performance characteristics of this device with clinical specimens has not been established. The assay can distinguish between influenza A and B viruses, but cannot differentiate influenza subtypes. The RAMP Influenza A/B Assay is marketed in the U.S. by 3M Health Care as the 3M Rapid Detection Flu A+B Test and is used to identify influenza A and B in human samples.

Ortho Clinical’s HBsAg Assay Approved

FDA approved Ortho Clinical Diagnostics’ VITROS Hepatitis B Surface Antigen (HBsAg) Assay for use on the VITROS 5600 Integrated and VITROS 3600 Immunodiagnostic Systems. The VITROS HBsAg Assay is designed for the qualitative detection of the hepatitis B surface antigen in human serum and plasma. The assay can be used as a quick and reliable test for HBV, or to screen for HBV infection in pregnant women to identify neonates at high-risk of acquiring HBV during the perinatal period.

SQI Diagnostics Platform, IgXPLEX Arthritis Assay Receive Clearance

SQI Diagnostics announced FDA clearance for its automated SQiDworks Diagnostics Platform and the multiplexed IgXPLEX rheumatoid arthritis (RA) assay. The fully automated platform enables labs to measure multiple biomarkers from a single sample and incorporates SQI’s IgPLEX technology to facilitate multiplexed measurement of multiple biomarkers. The IgXPLEX RA assay provides analysis of several biomarkers commonly used in the diagnosis of rheumatoid arthritis, including RF-IgA, RF-IgM, and anti-CCP-IgG.

PerkinElmer Cleared for Newborn Screening Platform, TSH Assay

PerkinElmer received FDA 510(k) clearance for its automated Genetic Screening Processor (GSP), which is used by public health labs for newborn screening programs. The processor allows labs to run multiple tests for irregularities associated with metabolic diseases on very low volume blood samples from newborns. The processor also enables both multi-analyte screening and traditional or enzymatic assays. The GSP Neonatal TSH assay is the first assay to receive clearance for the GSP, though additional newborn screening assays are currently in development.

AdvanDx Bloodstream Pathogen Test 510(k) Cleared

AdvanDx obtained FDA 510(k) clearance for a 90-minute protocol for its E.faecalis/OE PNA FISH test. The new protocol reduces the turnaround time from 2.5 hours to approximately 90 minutes by reducing the peptide nucleic acid (PNA) probe hybridization from 90 to 30 minutes. The test has been available since 2003 and uses PNA probes to target species-specific ribosomal RNA in live bacteria and yeast. bioMérieux distributes the E.faecalis/OE PNA FISH test in the U.S.

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