Tele: 561.316.3330
Breaking Medical Device News

Monday, September 20, 2021


HomeFDABreviTest Technologies Advises Their COVID-19 IgG Antibody Test Received Permission for Commercial Distribution by FDA

BreviTest Technologies Advises Their COVID-19 IgG Antibody Test Received Permission for Commercial Distribution by FDA

September 3, 2020

BreviTest Technologies announced that the FDA has officially accepted BreviTest’s official notification of its intent to commercially distribute its IgG antibody test under policy outlined in Section IV.D. of the Policy for Coronavirus Diseases – 2019 Tests.

The BreviTest SARS-CoV-2 IgG Test detects the presence of SARS-CoV-2 specific IgG antibodies in plasma or serum using only 3μl of sample. Reliable results are available in 10 minutes. A positive test result indicates prior exposure to the virus and potential immunity.

The BreviTest team performed a blinded clinical validation study using 111 human samples (serum or plasma), including 33 presumed positive samples from patients with PCR-confirmed COVID-19 infection, and 78 presumed negative samples collected prior to the pandemic. The BreviTest system classified each sample accurately, resulting in 100% sensitivity (positive predictive agreement) and 100% specificity (negative predictive agreement). BreviTest’s application for Emergency Use Authorization (EUA) for this test is currently under review at FDA. Assay validation for IgG quantitation and fingerstick collection is currently underway.

“The combination of high accuracy, small sample volume, and automated result reporting make this assay especially helpful for community surveillance as we head back to school and work,” said Dr. Atul Varadhachary, CMO of BreviTest and Managing Partner at Fannin Innovation Studio.  “Quantitation of IgG has been identified as a priority by FDA, and we are especially excited about completing validation of a finger-stick semi-quantitative IgG assay that can be performed in the field.”

The BreviTest system can perform complete laboratory-quality ELISA tests without the need for additional infrastructure. Technicians or nurses only need to add a drop of sample to a disposable cartridge and insert it into the portable Acuity™ analyzer. The system is designed to test a variety of analytes, including proteins, small molecules, and serum antibodies.

BreviTest’s developed its technology backed by private funding from Fannin Innovation Studio and research support from the National Institutes of Health (NIH).  Most recently, BreviTest received a $1.5 million SBIR award from the National Institute on Drug Abuse (NIDA) to develop rapid opioid urine testing for opioids. With the immediate need for rapid and reliable antibody testing, BreviTest expanded its product focus to include diagnostics related to the COVID-19 pandemic.

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Mark Foster Joins Xenocor BOD

Foster is a versatile and visionary C-Suite executive who brings 20 years of general management and leadership experience from both venture-backed growth-stage organizations and world-class medical device companies

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

By using this website you agree to accept Medical Device News Magazine Privacy Policy