The new test, developed and manufactured by BioMedomics (Morrisville, N.C.), will be available through BD and distributed exclusively by Henry Schein (NSDQ:HSIC) to healthcare providers throughout the United States.
The test does not require special equipment and may be used in a laboratory or at the point of care. It is designed to detects antibodies that are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure. This could help clinicians determine who has been exposed to the coronavirus, even if a person didn’t exhibit any symptoms of the COVID-19 disease, according to BD.
“Serology tests are important because they provide an additional piece of information to aid in characterizing possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity,” said BD integrated diagnostic solutions president Dave Hickey in a news release. “Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19. Our agreement with BioMedomics adds a rapid serology test that can augment current tests already on the market, and we are pleased to collaborate in this effort with Henry Schein, which has extensive knowledge of the point-of-care test field.”
The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients, according to BD.
Current FDA guidance recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Los Angeles-based Bodysphere today announced it has begun distributing an FDA-authorized molecular diagnostic test for COVID-19.
“BioMedomics designed the test to be easy to use and provide results in minutes, with no special equipment necessary or the need to transport the sample to a laboratory for analysis,” said BioMedomics CEO Frank Wang. “Our test has been clinically validated at several hospitals and clinical laboratories in both the U.S. and China, and our published clinical data in the Journal of Medical Virology was one of the world’s first for a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now ready to help combat coronavirus in the U.S. through our collaboration with BD. We are committed to doing our part to battle this disease and are excited to have BD as a partner to help deliver our high-quality rapid test to those who need it most.”
“We look forward to working with such an outstanding company as BD to help make the antibody test part of the standard of care,” added Henry Schein CEO Stanley Bergman. “The test will help to identify people who have developed antibodies to the virus, which may inform future strategies regarding COVID-19.”
The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance the agency issued March 16. BD expects to begin shipping tests in April and said it will have capacity to supply more than 1 million tests over the coming months.