US government health regulators have cleared a genetic test from Roche as a first-choice screening option for cervical cancer.
It was a role previously reserved for the Pap smear, the decades-old mainstay of women’s health.
The Food and Drug Administration approved Roche’s cobas HPV test to detect the human Papillomavirus, or HPV, in women 25 and up.
HPV causes nearly all cases of cervical cancer.
Doctors already use such DNA-based tools as a follow-up to confirm Pap test results.
But Thursday’s decision means Roche can now market its test as a first-choice option for cervical cancer screening, ahead of the Pap test.
Currently no major medical guidelines recommend HPV testing alone for cervical cancer screening.
Dr David Chelmow of Virginia Commonwealth University said physicians should hold off on using the test until medical societies can provide guidance on some key questions, including how frequently it should be used.
Chelmow spoke on behalf of the American College of Obstetrics and Gynecology at the FDA’s meeting to review the test last month.
Swiss-based Roche supported its bid for expanded marketing with study results suggesting 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.
The FDA approval comes despite pushback from public health advocates, who warned regulators that approving the DNA test as an alternative to Pap could lead to confusion, higher costs and overtreatment.
More than a dozen patient groups raised those concerns in a letter to the FDA last week.
Specifically, they said HPV-only testing could lead to overtreatment of younger women who carry the virus but have little risk of developing actual cancer.
Most sexually active young people contract HPV, though their bodies usually eliminate the virus within a few months. Only years-long infections develop into cancer.
FDA officials said in a statement on Thursday that they approved the test because “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness.”
The trial included over 47,000 women who underwent cervical screening using either Pap or HPV screening.
The test results were then checked for accuracy against final biopsy results that confirmed whether they actually had cancer.
For decades the Pap test was the only screening option for cervical cancer – and it’s had a remarkably successful track record.
The number of cervical cancer cases reported in the US has decreased more than 50 per cent in the past 30 years, primarily due to increased Pap screening.