True Diagnostics, Inc , a leading company for Point of Care (POC) answers, and Veravas, an emerging diagnostic company focusing on proprietary sample preparation products and new diagnostic tests, announced their Strategic Alliance in the commercialization of VeraTest Biotin, a portable and easy-to-use digital qualitative test that can rapidly screen patient samples to determine if significant biotin is present, helping safeguard against potential biotin interference. The collaboration, recently announced at the 71st Annual American Association for Clinical Chemistry (AACC) meeting in Anaheim, California, focuses on improving the accuracy of current diagnostic test results to ensure proper diagnosis, treatment and patient care management
Biotin, or B7, has become an everyday supplement for many people. It’s found in over the counter (OTC) multivitamins, prenatal vitamins, and dietary supplements for hair, skin, and nail growth, however, the use of high-dose biotin supplements has been found to skew results in some diagnostic tests. Today, 59% of immunoassay diagnostic tests on the market are using biotin in their assay design. As a result, in 2017, the FDA issued a safety communication alerting that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. In 2019, the FDA also issued guidance to IVD manufacturers regarding testing for biotin interference to address incorrect test results.
True and Veravas have partnered to develop a simple and immediate solution that screens for biotin interference. This new test leverages components from the TrueDX Reader Platform that was previously FDA cleared for a separate indication earlier this year. VeraTest provides a qualitative yes or no answer to determine if biotin levels are above 15 ng/ml – levels which may impact patient test results. With True’s manufacturing capabilities, proprietary screening assay platform and technology, in addition to Veravas’ nano magnetic particle technology that can remove and confirm the clinical significance of interferences, customers now have a way to detect and manage biotin interference while IVD companies work to update their assays.
“The number of people taking biotin for health and cosmetic reasons is becoming more prevalent each year, so we’re excited to announce this collaboration with Veravas to bring a product like VeraTest to market,” stated Jerry Lee, CEO and President of True Diagnostics. “Veravas is quickly emerging as the leader in raising the standard of care in laboratory medicine and we look forward to co-developing tools that are essential to support the IVD market and improving the lives of so many patients.”
“The issue of biotin interference has been discussed in the industry for years, so we’re excited to be first to market with a ready-to-use solution. Our collaboration with True utilizing their device technology has resulted in a test that’s easy to use and displays patient results in five minutes. Speed is critical in settings such as emergency departments, where a diagnostic answer is needed urgently to ensure proper diagnosis and treatment,” said Carroll E. Streetman Jr., Chief Executive Officer of Veravas. “We are confident that the combined technology of our two companies will assist healthcare providers and laboratory users to tackle biotin interference for improved test results.”
True and Veravas continue to collaborate and expand their portfolios with other emerging organizations and institutions to bring diagnostic solutions and products like VeraTest to market.
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 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.
Veravas is transforming laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnoses are accurate. The company is rapidly driving the commercialization of proprietary sample preparation products and new diagnostic tests. Veravas’ nano magnetic particles can identify, remove, and measure select substances from patient samples to reduce the effects of complex interferences and detect low-abundance biomarkers. Led by a passionate and dedicated team, Veravas is devoted to improving patient lives by minimizing the harmful effects of unnecessary treatments and deaths associated with poor quality diagnostic results. Because every patient deserves the correct result, every time. To learn more about our technologies and clinical applications, visit veravas.com.