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True Diagnostics, Veravas Partner to Commercialize Biotin Test

NEW YORK – Point-of-care test developer True Diagnostics said today that it has entered into a strategic alliance with Veravas to commercialize VeraTest Biotin, a portable test that rapidly screens patient samples to determine whether biotin levels are present that could throw off the accuracy of diagnostic tests.

VeraTest provides a 'yes' or 'no' answer to determine if biotin is above 15 ng/ml — levels that may impact patient test results, Carlsbad, California-based True Diagnostics said.

The new test combines use of True Diagnostics' screening technology and platform with Veravas' nanomagnetic particle technology, which can remove interferences and confirm their clinical significance, True Diagnostics said.

The TrueDX Platform produces quantitative results at the point of care using lateral flow immunoassay technology.

Carroll Streetman, CEO of Charleston, South Carolina-based Veravas, said in a statement that the new test provides results in five minutes. Such speed in obtaining results is important "where a diagnostic answer is needed urgently to ensure proper diagnosis and treatment," he noted.

Biotin, or B7, is found in multivitamins, prenatal vitamins, and dietary supplements for hair, skin, and nail growth. However, the use of high-dose biotin supplements can throw off diagnostic test results. In June, the US Food and Drug Administration issued a draft guidance that provides recommendations on testing for biotin interference with diagnostic tests.