FDA clears NOWDiagnostics' drop-of-blood test for early detection of pregnancy

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

NOWDiagnostics just received FDA clearance for its AdexusDx point-of-care test, which uses a single blood drop to diagnose pregnancy two to 8 days earlier in the process than its urine-based cousins.

The company says it's the first test of its kind to receive FDA's 510(k) clearance (though the differences between it and a recently cleared test from Abbott ($ABT) are fairly minor). AdexusDx detects the hormone human chorionic gonadotropin in capillary blood obtained via finger puncture or whole blood obtained intravenously, and does not require additional equipment.

The sample is drawn into the testing device. After 10 minutes, a band will appear in a certain location of the test window if the subject is pregnant.

Citing a study, the company says several urine-based hCG tests produce too many false-negative results.

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

AdexusDx is the Springdale, AR, company's first test to get the FDA's blessing. It has several CE-marked diagnostics for conditions like cardiac muscle damage and methanol poisoning, among others. They require a single drop of blood use the same testing device.

In April, Abbott got FDA's clearance for its hCG blood test, which also detects pregnancy quickly and early in the process. Unlike AdexusDx, Abbott's i-STAT Total β-hCG test uses two to three drops and a portable handheld analyzer.

And in January, Salt Lake City, UT's Sera Prognostics roped in $20 million in Series B funding to further its PreTRM test, a diagnostic tool which uses a routine blood sample collected during the second trimester of pregnancy to screen for preterm birth. The company eventually plans to target its proteomic technology towards other conditions such as preeclampsia or high blood pressure.

- read the release
- here's the news from FierceMedicalDevices