The U.S. Food and Drug Administration has approved a genetic-based test for use in cervical cancer screening, the first alternative technique to the long-standing Pap smear test to get U.S. approval.
The genetic test from Swiss pharmaceutical company Roche can be used in women who are 25 or older to test for human papillomavirus, or HPV, linked to the majority of cases of cervical cancer, the FDA announced.
DNA-based tests are already in use by doctors as a confirming follow-up procedure to Pap smear results, but the FDA approval means that Roche can market its genetic test as an alternative stand-alone screening procedure for cervical cancer.
The Roche test, which the company calls cobas HPV, can analyze cervical cells to look for 14 strains of HPV considered high risk, particularly two most dangerous strains, dubbed HPV 16 and HPV 18.
Roche says its cobas HPV test represents a more precise diagnostic than a Pap test as it can be used to identify risks of cervical cancer in its pre-cancer stage.
Some public health advocacy groups have been critical of the FDA decision, arguing approval of the Roche test as a possible alternative to the traditional Pap smear may create confusion, overtreatment and higher costs.
HPV testing without inclusion of a Pap smear may be overused on younger women who, in fact, carry the virus but face very little risk of developing cancer, some patient groups argued in a letter to the FDA during its deliberations.
The majority of sexually active younger people will contract HPV, the said, although their bodies will usually eradicate the virus in a matter of months and only infections that last for years will usually develop into cervical cancer, they said.
However, the FDA said in a statement, "Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness."
The Pap smear, previously the only cervical cancer screening option, has been remarkable successful.
Reported cases of cervical cancer have declined by around 50 percent in the United States over the past three decades, with medical professionals crediting an increase in Pap screening.
With the FDA approval of the Roche test, doctors will have a choice of screening techniques.
"Today's approval offers women and physicians a new option for cervical cancer screening," said Alberto Gutierrez of the FDA's Center for Devices and Radiological Health.
The American Cancer Society recommends women ages 21 to 29 get a Pap smear test every three years, while women age 30 and above are urged to get both Pap smears and an HPV test around every five years.
