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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.

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