Veravas receives CE Marks for three biotin diagnostic interference detection and mitigation products

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Novel technology to mitigate possible risk of biotin interference in immunoassays to be made available across the European Union.

Veravas, Inc. an early-stage biotechnology company, announced today that it has received Conformité Européene (CE) Mark approval for its suite of IVD interference detection and mitigation products.

VeraTest Biotin™ is a colloidal gold-based lateral flow assay to rapidly detect potentially problematic biotin interference in serum and plasma samples in only 5 minutes. VeraPrep Biotin™️ isolates and removes biotin interference from a serum or plasma sample pre-analytically using a simple 15-minute procedure. VeraPrep Biotin™ can be used stand-alone for detection of biotin interference or for further evaluation of biotin interference detected by VeraTest Biotin™.

Often found in multi-vitamins and over the counter health and beauty supplements, undetected high levels of biotin (Vitamin B7) in patient samples may cause false positive or negative results in certain clinical tests that are susceptible to biotin interference. In particular, IVD tests that employ streptavidin-biotin binding mechanisms have the potential to be affected by high circulating biotin concentrations. Unfortunately, biotin related analytical interference is not always detectable by the lab conducting the tests. The FDA has issued draft guidance advising diagnostics developers to test for biotin interference in their in vitro diagnostic devices (IVDs) that use biotin/streptavidin technology.

The suite of products consists of:

  • VeraTest Biotin™, a competitive binding lateral flow assay that uses a True Diagnostics™ Digital Reader to rapidly detect exogenous biotin levels greater than 15 ng/mL in only 5 minutes.
  • VeraPrep Biotin™, a sample pre-treatment system that uses streptavidin-coated magnetic particle technology and VeraMag™ magnetic separation to remove free biotin from an aliquot of plasma or serum. The difference in immunoassay results between non-treated and treated sample is used to detect the presence of biotin interference in samples for immunoassays that are susceptible to biotin interference.
  • VeraMag™, a magnetic particle separation device that uses neodymium magnets to separate different biomolecules for further analysis.

“Veravas is very pleased to be the only IVD company to offer CE Mark products to detect and remove biotin interference,” remarked Carroll E. Streetman, Jr., CEO of Veravas. Streetman added, “With routine biotin supplementation growing at an average rate of 20% per year, excess biotin in lab samples is one of the most common interferences and continues to exacerbate an already challenging interference issue with laboratory testing and accuracy of results.”

Regarding the Veravas products, Dr. Damien Gruson, Head of Medical Biochemistry Department, Saint-Luc University Clinics in Brussels, stated, “Knowing the issues related to laboratory test interferences and their potential impact on patient care and safety, we are happy to welcome new, reliable products in our arsenal for the fight against these interferences.”

With the CE mark, Veravas can now offer VeraTest Biotin and VeraPrep Biotin for clinical use across research, lab, hospital and health care settings in the European Economic Area (EEA) and in countries that observe EU standards. Elsewhere, including in the U.S., Veravas offers a Biotin Interference Starter Set for research and clinical evaluation use (RUO).

About Veravas, Inc.
Veravas, Inc. is an early-stage biotechnology company focused on transforming the practice of laboratory medicine with technology that delivers superior test results, providing confidence to clinicians and patients that diagnostic tests when performed are accurate. The company is rapidly driving the commercialization of proprietary sample preparation and sample interference products and development of new diagnostic tests for the IVD marketplace. Veravas is currently developing IVD testing solutions for the COVID-19 market utilizing its proprietary nanobead technology and VeraPrep™ reagents. To learn more about our technologies and clinical applications, visit veravas.com

https://www.linkedin.com/company/veravas/

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PRESS CONTACT
Available for interview

Carroll E. Streetman, Jr.
Chief Executive Officer
Veravas, Inc.
carroll@veravas.com

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