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FDA to Review Two Roche Genotyping Tests That Detect, Strain-Type HPV

NEW YORK (GenomeWeb News) — Roche Diagnostics today said that the US Food and Drug Administration will review for clearance a pair of its genotyping-based tests that detect and strain-type human papillomavirus.
 
According to Roche, the first test, called Amplicor HPV, will detect 13 high-risk HPV genotypes from clinical samples, while the other test, the Linear Array, will identify “which of those 13 types are in a particular sample.
 
Daniel O’Day, head of Roche Molecular Diagnostics, said HPV tests could help doctors “identify and manage persistent, high-risk HPV infections before they progress to more serious forms of the disease.”
 
Recent studies have shown that women infected with HPV are at increased risk for developing cervical cancer.

The Scan

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