The 10-minute, point-of-care blood test device will detect IgG and IgM antibodies specific to the 2019 novel coronavirus
PHOENIX (April 8, 2020) –– BioLab Sciences, a regenerative biotechnology company, today announced they are now distributing tests to detect antibodies specific to 2019n-CoV in humans. The test devices complete the screening using a blood sample from a finger prick and produce results in 10 minutes.
“The rapid antibody test detects the presence of IgG and IgM antibodies from COVID-19 generally available in whole blood, serum or plasma after an infection,” said Carlos Encinas, PhD, Chief Science Officer of BioLab Sciences. “With healthcare agencies and providers experiencing shortages and testing delays for molecular tests, these rapid antibody tests are a mission-critical need for the community to determine who has been infected by the novel coronavirus.”
BioLab Sciences has started distributing the test devices to healthcare agencies, hospitals, and outpatient facilities throughout the U.S.
“BioLab Sciences’ goal is to help healthcare providers obtain the resources they need to detect COVID-19,” said Bob Maguire, CEO of BioLab Sciences. “These tests will help equip physicians and healthcare leaders with the data they need to make informed public-health decisions and help guide the community as we navigate our future with this virus.”
The test, which is already being used throughout Europe and Asia, is still pending review by the U.S. Food and Drug Administration (FDA). However, as of March 16, 2020, the agency issued guidance to allow rapid antibody tests under emergency-use authorization.
“We look forward to working closely with healthcare providers and distribution partners to make these tests widely available,” said Jaime Leija, BioLab Sciences’ Chief Commercialization Officer. “In order to flatten the curve and mitigate infections in the future, it is critical to identify those who test positive for coronavirus exposure so they can take the right steps to quarantine and seek appropriate care from their physician.”
Testing with the COVID-19 IgG/IgM Rapid Test should only be performed in conjunction with other laboratory approved testing and/or clinical observations for the presumptive identification of viral infections in patients who may be infected with the novel coronavirus. All test results are presumptive and should be confirmed with an approved molecular assay. A presumptive negative test does not preclude the 2019n-CoV infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, a presumptive positive result does not rule out infections caused by other viruses.
About BioLab Sciences
BioLab Sciences is a regenerative medicine company focused on creating new ways to heal the body and identify health risks. Headquartered in Scottsdale, Arizona, BioLab Sciences is uncovering better ways to address orthopedic injuries, wound care, pain management, aesthetic medicine, respiratory ailments, cardiovascular indications, ophthalmic issues, and more. Learn more at www.biolabsciences.net/.