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Diagnostics FDA

 News Release - May 28, 2019

True Diagnostics, Inc. Receives FDA 510(k) Clearance to Market VeriClear(TM) Digital Test Device for Early Result Pregnancy

SAN DIEGO, May 28, 2019 -- (Healthcare Sales & Marketing Network) -- True Diagnostics, Inc. (True), a leading company for Point of Care Answers, announced today that its VeriClear™ Digital Early Result Pregnancy Test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for detecting human chorionic gonadotropin (hCG) levels in women prior to their first missed period.

The test offers the ability to detect a pregnancy as early as six (6) days prior to a missed period and provides the patient a clear digital "Yes" or "No" result. Global market sales for point-of-care (POC) diagnostic products used outside of the hospital setting were valued at 10.8 billion. The home/self-testing POC products market accounted for approximately 56% of the total global market for POC diagnostic products.

True's VeriClear Digital Early Result Pregnancy Test is the successful result of combining the company's proprietary Test Platform (TrueDX™ Platform) with its growing Co-Development Partnership Program to enable and support test solutions for Point-of-Care and Self-Testing markets. CEO and Founder Jerry Lee announced that with the new 510(k) FDA clearance "...we are very excited to bring VeriClear's Digital Early Pregnancy Test to market. 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 latest addition to the company's growing portfolio of diagnostic devices. It is the third device from True's product portfolio to receive FDA clearance within the last 16 months and it follows the clearance of the VeriClear Early Result Pregnancy Test in analog format. The device is aimed to deliver a simple, fast, and easy way for healthcare professionals and consumers to read test results.

About True Diagnostics

True Diagnostics (True) designs and develops innovative POC 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 offer rapid diagnoses to facilitate treatment decisions in point-of-care, point-of-incidence and remote-of-care settings. The TrueDX Platform's portability and affordability allow it to be easily adopted into emerging markets to provide an accurate diagnosis within minutes. For the $21 billion point-of-care market, the power of the TrueDX Platform lies in its simplicity and flexibility. Tests have an 18-month or longer shelf life with no refrigeration required. The platform's flexible design additionally permits it to quickly commercialize a myriad of biomarkers discovered for cancer, autism, Alzheimer's, diabetes, drugs of abuse, infectious diseases, cardiac health, traumatic brain injury, viral and bacterial infections and more.


Source: True Diagnostics

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