American Association for Clinical Chemistry
Better health through laboratory medicine
November 2010 Clinical Laboratory News: News from the FDA

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November 2010: Volume 36, Number 11

Ariana to Provide FDA with Genomic Data Tools

The Food and Drug Administration has enlisted Paris-based Ariana Pharma to provide its biomarker data mining technology to the agency. The collaboration is aimed at developing better tools for analyzing genomic data to be used in personalized medicine. According to Ariana, FDA will use the company’s KEM biomarker technology to analyze data combined with patient characteristics for biomarker signatures that were submitted to FDA through its voluntary exploratory data submission program.

Gen-Probe Files PMA for Urine Prostate Cancer Test

Gen-Probe has submitted an application to the FDA seeking premarket approval for its molecular test designed to help determine the need for repeat biopsies in men suspected of having prostate cancer. The test, Progensa PCA3, would be used on urine samples from men who earlier had a negative prostate biopsy. According to the firm, Progensa PCA3 is the first urine-based molecular diagnostic test for prostate cancer.

Roche’s Second-Generation Hepatitis B MDx Test Cleared by FDA

FDA has cleared Roche’s second-generation Cobas AmpliPrep/Cobas TaqMan HBV test for marketing. The new molecular test offers a fully automated solution for the quantitative detection of hepatitis B virus (HBV) DNA in human plasma or serum for patients on HBV antiviral therapy. According to Roche, the test will allow clinicians to follow best practices in patient care with standardized viral load measurements, a broad range of detection, and high sensitivity.

Phadia’s Celiac Disease Diagnostic Tests Get Clearance

Phadia US has obtained FDA clearance for its EliA GliadinDP IgA and EliA GliadinDP IgG gliadin tests with deamidated peptides used to diagnose celiac disease. The automated gliadin tests reduce the risk of generating false positive results and may be used to guide treatment and decrease the need for intestinal biopsies.

FDA Clears Roche’s Cobas 8000 Modular Analyzer Series

Roche Molecular Diagnostics has received FDA clearance for its cobas 8000 modular analyzer series designed for high-volume laboratories that process 3–15 million tests per year. The cobas 8000 series, which combines clinical chemistry and immunochemistry testing, is the latest addition to the Roche cobas modular platform.