NOWDiagnostics Inc. of Springdale has received federal approval to market its First To Know Syphilis Test, the first at-home, over-the-counter test to detect the sexually transmitted infection.
The test provides an at-home result without a prescription in about 15 minutes, which can be used to better inform a person’s next steps with a health care provider, the U.S. Food & Drug Administration said in a news release.
The FDA reviewed the product under the agency’s De Novo pre-market review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with the De Novo authorization, the FDA is establishing special controls that define the requirements related to labeling and performance testing. The special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type, the FDA said.
The test gained marketing authorization amid a surge in syphilis and congenital syphilis cases nationwide. Earlier this year, the U.S. Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to respond to the growing number of infections.
The FDA said authorizing NOWDiagnostics’ test will directly contribute toward a national strategic plan to reverse the rise in infections.
“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said in the release. “Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure.”
NOWDiagnostics’ over-the-counter syphilis test works by detecting syphilis antibodies in a person’s blood. The test is among more than 30 in the company’s clinical research pipeline.
NOWDiagnostics has said its technology allows virtually any immunological test to be accurately performed in one step using a small amount of capillary blood, yielding results in minutes.
The company, founded in 2013, announced last month that it raised $22.5 million in Series B financing.
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