Le Lézard
Classified in: Health, Science and technology, Covid-19 virus

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


CHARLESTON, S.C., Sept. 30, 2020 /PRNewswire-PRWeb/ -- 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 Biotintm 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 Biotintm? isolates and removes biotin interference from a serum or plasma sample pre-analytically using a simple 15-minute procedure. VeraPrep Biotintm can be used stand-alone for detection of biotin interference or for further evaluation of biotin interference detected by VeraTest Biotintm.

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 The FDA has issued draft guidance advising diagnostics developers to test for biotin interference in their in vitro diagnostic devices (IVDs) that use biotin/streptavidin technology.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:

"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 VeraPreptm reagents. To learn more about our technologies and clinical applications, visit veravas.com

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

# # #

PRESS CONTACT
Available for interview

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

 

SOURCE Veravas


These press releases may also interest you

at 22:33
Corventive Health, a provider of cloud-based and AI technology solutions, announced a partnership with Halfpenny Technologies, an Accumen, Inc. company today. This partnership fortifies Corventive's core capability of delivering clinical insights...

at 22:03
Alterity Therapeutics ("Alterity" or "the Company") today announced it has commenced enrolling patients with Multiple System Atrophy (MSA) in its bioMUSE Study in the United States....

at 20:39
Trusted health and lifestyle expert, Dr. Yael Varnado gives advice for fall health and wellness. Dr. V is a practicing physician. STAYING WELL Taking better care of ourselves can be as easy as swapping out a light bulb. Choosing the right lighting...

at 20:10
Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the Center for Drug Evaluation (CDE) of...

at 20:00
Drawbridge Health, a healthcare technology company redefining the blood draw experience for both patients and healthcare providers, today announced a further investment from Sumitomo Dainippon Pharma Co., Ltd. ("Sumitomo Dainippon Pharma") as well as...

at 19:35
EdiGene, Inc. ( "Company", or "EdiGene"), today announced the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has accepted for review the Company's Investigational New Drug (IND) application for ET-01,...



News published on 30 september 2020 at 21:00 and distributed by: