The Food and Drug Administration (FDA) has given its green signal to Roche Molecular Systems’s alternative papilloma virus test to treat cervical cancer, in women aged 25 and older.
The test, commonly known as the Cobas HPV test, is a DNA-based test for the virus that can cause cervical cancer.
Such DNA-based tools are being used by the doctors as a follow-up to confirm Pap test results. But FDA’s nod has given Roche an open market to launch its test as a first-choice option for cervical cancer screening, ahead of the Pap test.
The research and clinical trial for the newly FDA-approved Cobas HPV test was conducted in Pleasanton. After the FDA nod, the medical exam will soon be available nationwide.
Hailing the decision, Paul Brown, CEO of Roche Molecular Systems, said, “This is all about preventing cervical cancer. This new FDA-approved exam proved its worth in clinical tests on 47,000 women.”
He further said that the new medical test would allow the doctor to make a decision about whether the woman was at risk or had cervical cancer.
Meanwhile, the Cobas HPV test was not welcomed by many as they claim it may not be “a proper predictor.” They have also condemned the developers for the whopping costs of the test, which is more than twice as much as the traditional Pap smear screening.
Brown and company has played down the criticism, saying: “If you can prevent the woman from getting cervical cancer, you have a very significant benefit to the health care system because having to manage and treat a woman that gets cervical cancer is extremely expensive.”
According to David Chelmow of Virginia Commonwealth University, physicians should hold off on using the HPV test until medical societies can provide guidance on some key questions, including how frequently it should be used.
Swiss-based Roche supported its bid for expanded marketing with study results suggesting that genetic testing is more accurate and objective at identifying cancerous growths than the Pap smear, which requires doctors to examine cervical cells under a microscope for signs of cancer. The test detects 14 high-risk forms of HPV that can lead to cervical cancer.