BreviTest's COVID-19 IgG Antibody Test Receives FDA Commercial Distribution Approval

BreviTest Technologies announced the U.S. Food and Drug Administration (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.