FDA has granted 510(k) market clearance to the VeriClear digital early-result pregnancy testfrom point-of-care diagnostics company True Diagnostics, San Diego. The test is intended to detect human chorionic gonadotropin (hCG) in women prior to their first missed period.
The VeriClear test is able to detect a pregnancy as early as 6 days prior to a missed period, and provides the patient a clear digital ‘yes’ or ‘no’ result. The device is designed to deliver a simple, fast, and easy way for healthcare professionals and consumers to read test results.
The test is the successful result of combining the company’s proprietary TrueDx platform with its growing codevelopment partnership program to enable and support test solutions for the point-of-care and self-testing markets.
“We are very excited to bring the VeriClear digital early-result pregnancy test to market,” says Jerry Lee, CEO of True Diagnostics. “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.”
The VeriClear digital early-result pregnancy test is the third device from the True Diagnostics product portfolio to receive FDA clearance within the past 16 months, and it follows the agency’s clearance of the VeriClear test in analog format.
True Diagnostics designs and develops innovative diagnostic tests and devices based on its proprietary TrueDx platform, which utilizes reliable and low-cost lab methods and its own proprietary or partnered biomarkers to facilitate treatment decisions in point-of-care, point-of-incidence, and remote-care settings. The portability and affordability of the TrueDx platform allow it to be easily adopted into emerging markets. TrueDx tests have an 18-month or longer shelf life, with no refrigeration required.
For further information, visit True Diagnostics.