Roche Wins FDA ApprovalAccording to the National Institutes of Health, about 12,360 women will be diagnosed with cervical cancer in 2014 and 4,020 will die from the disease. Early detection can possibly help the disease from developing. Women now have hope with a new genetic test from Roche Holding AG (ROG). The Food and Drug Administration (FDA) has approved the Roche Cobas HPV test to detect the human Papillomavirus (HPV) in women 25 and older. This is the first test to screen for cervical cancer that will serve as an option to a Pap smear.

HPV is responsible for almost all cases of cervical cancer. Roche’s test detects the DNA from 14 human papillomavirus types in a sample taken from the cervix. In Pap testing, the cervical sample is examined under a microscope to detect abnormalities. The new test primarily detects two types of HPV responsible for about 70 percent of cervical cancers. Women testing positive for one of those two types should get a pap test to determine if a colposcopy is necessary. If a woman tests negative for the two types of HPV responsible for cancer, but positive for one or more of the other 12 types the test can detect, she would then have to follow up with a Pap test to see if a colposcopy was necessary.

Studies have shown that compared to Pap testing, HPV testing can detect more precancerous lesions. However, HPV testing has not been used in women younger than 30 as it could result in more false alarms as the presence of the virus is not full proof of the existence of cancer. According to Roche, its new test overcomes this problem as it specifically detects the two types of the virus that account for 70 percent of cervical cancers.

Several consumer, women’s and health groups as well as group of doctors and professors wrote to the FDA opposing the approval on the basis that it had not been sufficiently tested. They argued that the current practice of pap smears every three years starting at age 21 with the option of using a combination of a Pap smear and HPV test at age 30 has successfully prevented cervical cancer for decades.

The F.D.A. however considered Roche’s evidence was adequate.

Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer”, said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

Roche can now market its test as a first-choice alternative for cervical cancer screening, ahead of the Pap test.

The world leader in in-vitro diagnostics, Roche’s primary focus is on developing new and improved drugs, diagnostic tests, and services that offer major benefits over existing options. The company’s new genetic test for the detection of cervical cancer provides proof of its commitment to these goals.