FDA Makes History, Approves New Alternative to the Pap Smear
The Food and Drug Administration approved a new test Thursday that will serve as an alternative to the long-used method of cervical cancer testing, the Pap smear. According to The Washington Post, the new test, called cobas, was developed by Roche, and it marks the first alternative to the Pap smear that has been approved by the U.S. The approval of cobas is significant because HPV causes nearly all cases of cervical cancer, and researchers have long been studying ways to identify HPV DNA in ways other than the decades-old Pap smear.
The Washington Post explained Thursday that the new test detects the DNA of the human papilloma virus in women 25 or older in a sample taken from the cervix. Though doctors have long employed similar DNA-based tools as part of their follow-up to Pap test results, examining the cervical sample under a microscope, Roche’s new test is the first stand-alone option for cervical cancer screening and may be one step easier than the Pap test.
However, the Pap smear has also been widely successfully for many decades now, and that’s why certain health groups are demonstrating a resistance to the approval of the new test. According to The New York Times, even though Roche representatives met with a group of advisers to the FDA who all supported the new test in March, several women’s health groups have been vocal about the dangers of approving the DNA test as an alternative to Pap testing. They argue that the implications of the approval could include patient confusion, over-treatment, and higher costs, and the Cancer Prevention and Treatment Fund organized a letter that was sent to the FDA earlier this month saying, “This proposed indication for the HPV test would represent an unprecedented and significant shift in clinical practice that would affect millions of women for the majority of their adult lives.”
Similar letters were also penned to the federal agency in March and April, but the FDA has stood its ground and decided to approve Roche’s new test regardless. According to The Washington Post, the agency’s argument is that “Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness” of the test, and that trial involved more than 47,000 women who underwent cervical screening using either Pap or HPV screens. The test results were checked for accuracy against final biopsy results, helping doctors determine whether or not the patients had cancer.
So now, despite the concern from consumer advocates that the HPV-only testing could lead to over-treatment of women who carry the virus but aren’t expected to actually develop cancer, leading to increased costs, the FDA has approved the test, and Roche will move forward to the next step in the process. The Washington Post reported Thursday that Roche will now be allowed to market its test to women as young as 25, and those who test positive for certain strains of HPV will be directed to have a colposcopy, which is an invasive test in which doctors view the cervix with a magnifying device and collect a tissue sample for testing. From cobas’s initial results on the market, researchers will determine what Roche’s next steps will be.