CLN Article

News From the FDA

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Quidel Receives FDA Clearance for RSV + hMPV Test

FDA has cleared Quidel's Molecular RSV + hMPV assay for detecting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and distinguishing between them. This duplex test shares a common extraction protocol with other Quidel molecular assays and can be run in batches simultaneously in the same multi-well PCR panel for customized multiplexing capability. The RSV + hMPV assay is Quidel's third molecular PCR assay to receive 510(k) clearance. Previous Quidel tests cleared by FDA include the company's molecular assays for Influenza A+B and hMPV, and its C. difficile assay in the AmpliVue format.

FDA Approves Abbott Test for Birth Defects, Testicular Cancer

Abbott has received FDA approval for its Architect AFP test for detecting serious birth defects and monitoring the progression of testicular cancer. Alpha-fetoprotein (AFP) is a biomarker that increases in mothers carrying a fetus affected by neural tube defects and in men with nonseminomatous testicular cancer. Abbott's new test quantifies AFP levels in human serum, plasma, and amniotic fluid at 15 to 21 weeks gestation using chemiluminescent microparticle immunoassay technology, and it runs on Abbott's fully-automated Architect i2000, i2000SR, ci8200, and ci16200 analyzers.

Quidel and Life Tech Receive Simultaneous Clearances

FDA granted Quidel and Life Technologies 510(k) clearances to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio Dx and 7500 Fast Dx Applied Biosystems real-time PCR instruments. The Quidel Molecular Direct C. difficile Assay kit includes an extraction-free, three-step sample preparation process that bypasses the need for a heat step, timed step, and centrifugation and generates results in less than 70 minutes.

The QuantStudio Dx real-time PCR instrument includes a touch screen, reagent and sample tracking capabilities, and a laboratory information management systems interface. Its six-color feature allows users to multiplex six targets in one reaction. The instrument provides an optional test development mode that accommodates 96- or 384-well plates and can perform pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other non-coding RNA analysis, and high-resolution melt analysis. It also accepts a proprietary qPCR microfluidics card that can perform 48 tests on eight samples simultaneously without liquid-handling robots and that can be used to design and implement custom tests.

Beckman Coulter Gets FDA Nod for Hemoglobin A1c Assay

FDA cleared Beckman Coulter's new hemoglobin A1c assay (HbA1c-) for quantitative determination of HbA1c concentration in whole blood. Designed for use with Beckman's UniCel DxC System and Synchron/AU Hemolyzing reagent, the assay improves accuracy and precision, according to the company's press release. It also meets the latest accuracy grading from the College of American Pathologists and the recommendations of the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine. The assay is standardized and holds a certificate from the NGSP. Features of the new assay include ready-to-use liquid reagents for A1c and total hemoglobin, a 5-level calibrator set, 30-day on-board reagent stability, and 7-day calibration stability. Additionally, it eliminates cross reactivity with HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, and glycated albumin, as well as significant interference from hemoglobin variants HbS, HbC, HbD, HbE, and HbF.

Meridian's Group A and B Streptococcus Tests Rated Moderate Complexity

FDA has re-categorized Meridian's illumigene Group A Streptococcus and Group B Streptococcus tests as moderate complexity under CLIA. The Group A Streptococcus test is a qualitative molecular test for detecting Group A Strep pharyngitis. According to the company's press release, clinical studies show that the new test increased detection of positives by 53% over traditional culture in symptomatic patients. In addition, clinical studies also showed that broth enrichment followed by testing with illumigene Group B Streptococcus increases detection of Group B Streptococcus (GBS) positives by 29% over traditional culture. The latter test also fully complies with Centers for Disease Control and Prevention guidelines for the detection of Group B Strep.