Updated July 11, 2019
Biotin, an ingredient commonly found in certain dietary supplements can cause false test results. The problem, which FDA brought to the industry's attention in 2017, is that many immunoassay-based tests on the market use streptavidin/biotinylation binding in the assay design. This renders the test susceptible to excess biotin levels and can result in inaccurate results.
That's where Veravas comes in.
Veravas, an emerging diagnostics company founded in 2017, just launched a portfolio of products aimed at solving the biotin-interference problem. The products are designed to improve the accuracy of current diagnostic test results by helping laboratory professionals detect and manage biotin interference in patient samples with VeraTest Biotin and VeraPrep Biotin. The new VeraBind Biotin will support diagnostic manufacturers in redeveloping lab assays to be biotin-interference free, the company said.
Biotin is found in over-the-counter multivitamins, prenatal vitamins, and dietary supplements for hair, skin, and nail growth. The use of biotin is steadily increasing worldwide. Taking high-dose biotin supplements can interfere with laboratory assays and cause incorrect test results. Ultimately, this interference can lead to misdiagnosis, inappropriate patient management, and adverse events. It's a big enough problem that FDA has issued guidance to in vitro diagnostic device manufacturers to include clear labeling indicating biotin-interference levels for clinical laboratories and clinicians to consider when interpreting test results.
“As the number of people taking high-dose biotin supplements continues to grow, and many labs don’t have an easy-to-use solution to effectively measure biotin, the potentially harmful impact of inaccurate test results also rises. This portfolio of products can help to reduce the impact of biotin interference and marks our first step towards helping laboratory professionals have more confidence in the accuracy of test results reported to clinicians,” said John Forrest, founder and CEO of Veravas. “Better results are key to correct diagnosis and effective interventional therapy, ultimately leading to better patient care.”
The new products include:
- VeraTest Biotin, an easy-to-use digital qualitative test to identify biotin in a sample
- VeraPrep to rapidly remove biotin from samples prior to running the assay
- VeraBind Biotin an alternative to streptavidin, the substance that causes biotin interference, which is designed to help manufacturers improve their tests to eliminate interference
As MD+DI reported back in 2017, FDA has noticed an increase in the number of reported adverse events, including at least one death, related to biotin interference with lab tests. The patient death was linked to falsely low troponin test results when a troponin test known to have biotin interference was used.
A lot of dietary supplements promoted for hair, skin, and nail benefits contain biotin levels up to 650 times the recommended daily intake, FDA said. Doctors may also be recommending high levels of biotin for patients with certain conditions such as multiple sclerosis.
FDA said lab test manufacturers with assays that use biotin technology should contact the agency to discuss biotin interference. Manufacturers should also investigate interference from biotin (up to at least 1200 ng/mL biotin) in assays that use biotin technology, and determine the lowest concentration of biotin that may cause clinically significant interference, the agency said.
In addition to monitoring reports of adverse events linked to biotin interference, FDA said it is working to better understand biotin interference with lab tests, and to develop additional safe-testing recommendations in patients who have taken high levels of biotin when using laboratory tests that use biotin technology.