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True Diagnostics Gets US Clearance for Digital Pregnancy Test

NEW YORK (360Dx) — True Diagnostics announced today that it has received 510(k) clearance from the US Food and Drug Administration for its VeriClear Digital Early Result pregnancy test.

According to the Carlsbad, California-based company, the point-of-care test is designed to detect human chorionic gonadotropin levels in women. It is self administered and can detect pregnancy as early as six days before a first missed period, providing a "yes" or "no" result.

"This represents the first of many digital devices we expect to make available in the near future, including TSH for thyroid disease, PSA for prostate health, and other novel applications through our robust strategic partnership pipeline," True Diagnostics Founder and CEO Jerry Lee said in a statement.