Roche test for HPV recommended by FDA committee
pharmafile | March 13, 2014 | News story | Sales and Marketing | Cancer, FDA, HPV, Roche, cervical, cobas
An FDA advisory committee has recommended that a DNA test developed by Roche be approved for use as a primary screening tool.
Roche’s cobas test detects the DNA of human papillomavirus (HPV) which causes almost all cases of cervical cancer, and until now HPV testing has been used mainly as a follow-up test when Pap results were ambiguous.
Its US recommendation is significant as it could mean the standard Pap test, a ritual for women that has been the mainstay of cervical cancer prevention for 60 years, could play a less crucial role in the future.
Dr Thomas Wright, Professor Emeritus of Pathology and Cell Biology, Columbia University Medical Center in New York, said: “I am pleased that the FDA panel recognised the importance of validated, scientific evidence documenting the use of primary HPV screening to detect women at risk of invasive cervical cancer and allow us to prevent cervical cancer from developing.”
The committee voted overwhelmingly in favour of Roche’s offering to be used alone as the initial test for women 25 and older – who could be at risk for cervical cancer.
Should the FDA itself agree with its advisory committee and approve the new use of Roche’s process, it could become a welcome option over older testing regimens (although not necessarily a replacement for).
A positive ruling could indeed prove lucrative for the Swiss firm as according to market research firm DeciBio, the US market for such tests sits at around the $200 million mark.
Roche says according to the National Cancer Institute there are more than 12,000 new cases of cervical cancer in the US every year, and 4,210 deaths due to the disease. The World Health Organization estimates there are more than 500,000 new cases of cervical cancer annually it says.
Roland Diggelmann, chief operating officer of Roche’s Diagnostics unit said: “We look forward to working with the FDA and medical community to support the growing understanding and awareness of the role that HPV plays in cervical disease, and the importance of the cobas HPV Test, which provides the necessary medical benefit to become the first line test in a cervical cancer screening strategy.”
Brett Wells
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