NOWDiagnostics gets FDA blessing for one-step pregnancy test

NOWDiagnostics' AdexusDx hCG early pregnancy testing kit--Courtesy of NOWDiagnostics

NOWDiagnostics nabbed an FDA OK for its one-step pregnancy blood test, a win for the company as it builds out its offerings and vies for a share of a rapidly expanding pregnancy testing market.

The Springdale, AR-based company's AdexusDx hCG test scans for a common pregnancy hormone in a single drop of blood, determining whether or not a woman is pregnant well before urine-based tests. Depending on the woman and her pregnancy, the test can detect pregnancy two to 8 days before urine-based products, delivering results in about 10 minutes, the company said in a statement.

NOWDiagnostics is aiming to simplify the testing process for early pregnancy with its product. Diagnostic kits can be processed in less than 15 minutes by on-site lab technicians, staff technicians and nurses, the company said in a statement, potentially saving providers time, money and resources.

"It's too important for the safety of the mother and fetus not to have accurate pregnancy results in our emergency rooms and clinics," CEO Kevin Clark said in a statement. "Our hCG test can save lives and reduce liability for healthcare providers."

But its pregnancy test in not the only product NOWDiagnostics has in its arsenal. The company also offers two heart attack tests and three toxicology tests in Europe. And more products are moving down the pipeline, including tests for sexually transmitted diseases, food intolerances and common infectious diseases.

Meanwhile, other companies such as Abbott ($ABT) are looking to make their mark on early pregnancy testing. In April, the med tech giant got an FDA greenlight for its early pregnancy blood test, which scans for hCG in whole blood or plasma and delivers results on a portable handheld analyzer. But unlike NOWDiagnostics' test, which uses one drop of blood, Abbott's test uses two to three drops to screen for hCG in 10 minutes.

- read NOWDiagnostics' statement