8:41 p.m. | Updated with Rite Aid comment
A test to detect two common sexually transmitted diseases is now available in certain drug stores. But the Food and Drug Administration says it may have to come off the shelves.
The product, being sold at most Rite Aid stores, is the first test for chlamydia and gonorrhea to be sold through a drug store, according to Identigene, the test developer.
But the F.D.A. on Thursday sent a letter to Identigene saying the test had not been approved by the agency.
The action is the latest in a crackdown by the F.D.A. on medical tests being offered directly to consumers. In May, a similar F.D.A. letter led to the cancellation of a plan by Walgreens to sell a genetic test developed by Pathway Genomics that would predict a person’s risk of getting various diseases.
Steve Smith, executive director of Identigene, said the company has already replied to the F.D.A. saying that the test it uses in its laboratory, developed by Gen-Probe, has already been approved.
“There’s no reason for Rite Aid or anyone to discontinue selling the test,’’ he said Friday. Eric Harkreader, a spokesman for Rite Aid, said the company was investigating the matter.
But Dr. Alberto Gutierrez, director of in-vitro diagnostics for the F.D.A., said in an interview Friday that even Identigene’s urine sample collection kit needed to be approved.
Who will win this standoff is unclear, though the F.D.A. generally has the upper hand.
Regulation of diagnostics is clearly in flux. The F.D.A. is moving toward more oversight of so-called laboratory developed tests, which it once declined to regulate. These are tests offered by a single laboratory, with all samples sent to that lab, as opposed to a test kit that is widely sold to hospitals and laboratories. .
The agency is also moving to oversee tests, including genetic tests, offered directly to consumers over the Internet or through retailers.
New York State has its own strict regulation of tests, so the Identigene test is not being sold in Rite Aid stores in New York.
What Identigene is selling in Rite Aid is a urine collection kit, which costs $20. The consumer then must mail the urine sample, along with a $99 laboratory processing fee, to Identigene’s laboratory. The company says results will be available two to three days after it receives the sample.
Mr. Smith said an at-home test might encourage more people to be tested.
“We think there’s a significant proportion of this market who may prefer a private option,’’ he said. “There are many people who need to be tested but aren’t.’’
F.D.A. officials said they needed to first confirm the test was accurate.
There are “a lot of social implications if there is a false result, as you can imagine,’’ said Dr. Sally Hojvat, director of microbiology for the medical device division at the agency.
Another concern of the F.D.A. is whether people who test positive will have access to a doctor. Mr. Smith said Identigene has doctors on contract who will approve each test ordered and release the result. But he said the company could not ensure the doctors would talk to patients.
Cases of chlamydia and gonorrhea cases are supposed to be reported to the Centers for Disease Control and Prevention. It is not clear who would be responsible for that with the home test.
The C.D.C. estimates there are about 2 million new cases of either chlamydia or gonorrhea in the United States each year. Many of the cases produce no symptoms, meaning people can spread the diseases unknowingly.
Various diagnostic tests have been approved by the F.D.A. for sale over the counter in drug stores, including those for pregnancy, blood glucose, cholesterol and even H.I.V.
Identigene, which is based in Salt Lake City, is affiliated with an ancestry testing company called Sorenson Genomics. Three years ago, Sorenson and Rite Aid introduced what they said was the first DNA test to be sold through a drug store – a paternity test.
