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US FDA approves Roche Cobas HPV Test

pharmafile | July 8, 2016 | News story | Medical Communications, Research and Development HPV, Roche, US FDA, regulation 

The US Food and Drug Administration (FDA) has approved cancer drugmaker Roche’s (VTX: ROG) cobas HPV Test.

The first test for Human Papilloma Virus or HPV that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.

The test is manufactured by Roche while SurePath Preservative Fluid is manufactured by US-based Becton Dickinson and Company.

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The FDA approved HPV tests to be used with specific collection fluid, which store and preserve cervical cell samples for testing in the laboratory.

The test is approved for use with cervical cell samples obtained for a Pap test to screen women age 30 and older for HPV in order to determine whether additional follow-up and diagnostic procedures are needed.

HPV infections are the most common sexually-transmitted infections in the US, and HPV genotypes 16 and 18 cause about 70% of cervical cancers worldwide. According to the National Cancer Institute, there will be an estimated 12,990 new cases and 4,120 deaths from cervical cancer in the US in 2016.

Anjali Shukla

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