FDA Advisory Forces Company to Suspend US Sale of Screening Test

Last week, the FDA issued a safety alert warning women and physicians on the risks associated with using ovarian cancer screening tests, citing concerns with false negatives that can delay necessary treatment. Less than a week later, one of the manufacturers of such a test, London-based Abcodia, has announced that it will temporarily stop sales of its Risk of Ovarian Cancer Algorithm (ROCA) test in the United States.

The FDA has had no role to play in the approval of ROCA. Being a laboratory-developed test (LDT)—which monitors changes in the levels of CA-125 protein in the blood—ROCA falls under the regulation of the CMS-developed Clinical Laboratory Improvement Amendments, not the FDA. Late last year, the FDA released a report documenting the harms—both clinical and monetary—associated with false-positive or false-negative results from LDTs, considering the widespread use of these products that cost Medicare $9.7 billion in 2012 alone. ROCA, priced at $295, is currently sold throughout the United States, except in Alaska, Florida, Hawaii, and New York.

According to the company, the test has been developed for use in conjunction with a transvaginal ultrasound in postmenopausal women who are asymptomatic and have no known risk factors for ovarian cancer. Results from the ROCA test could be used to decide further investigation by a gynecological oncologist. Early diagnosis of ovarian cancer is important. While the cancer afflicts only 3% of women in the United States, it is the fifth leading cause of cancer-related deaths in the country, primarily because specific disease-related symptoms develop late in the game when the cancer has metastasized. There is, therefore, a niche for developing an efficient test for early diagnosis of ovarian cancer. CA-125, however, may not be the most accurate biomarker to follow, since the protein expression is affected by several factors.

Commenting on the need for such a test in ovarian cancer, Karen Lu, MD, chair of gynecologic oncology and reproductive medicine at the University of Texas MD Anderson Cancer Center, told Forbes, that the ROCA test was quite vigorously studied in the United Kingdom and the results of the exhaustive 200,000-participant randomized trial were published inLancet. Lu is leading an ongoing trial of the test across 7 centers in the United States that is independently being funded by MD Anderson and some philanthropies. While studies have shown that the ROCA test does not cause any harm or lead to unnecessary surgeries, it is important to ascertain if it detects ovarian cancer early enough to actually save lives, Lu added.

Tara Goodin, press officer at the FDA, wrote in an e-mail to Forbes, “The FDA is not aware of valid scientific data supporting the use of any test for ovarian cancer risk assessment in asymptomatic women,” and that a final guidance on the regulation of LDTs will soon be released by the FDA.

Meanwhile, Abcodia said in a press release that it will continue to maintain an open channel of communication with the FDA regarding ROCA and will also continue to evaluate the test in collaboration with community physicians and medical centers.