RESEARCH TRIANGLE PARK – Morrisville-based BioMedomics, a small diagnostics company supported by the North Carolina Biotechnology Center, has partnered with BD (Becton Dickinson & Co.) to launch its new blood test for COVID-19 that can detect the infection within 15 minutes.
BD, a global medical technology company with deep expertise in diagnostics, said it expected to begin shipping tests in April and would have the capacity to supply more than one million tests “over the coming months, with the ability to scale up based on market demand.”
The tests will be manufactured at a BioMedomics subsidiary facility in China, and BD will rely on medical products distribution company Henry Schein to distribute them to medical care facilities throughout the United States.
The point-of-care test can detect antibodies in blood to confirm current or past exposure to COVID-19, the infection caused by the SARS-CoV-2 coronavirus.
“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 Frank Wang, chief executive officer of BioMedomics.
TEST DEPLOYMENT GROWING
The test has not been reviewed by the U.S. Food and Drug Administration but is permitted for distribution and use under the public health emergency guidance issued by the FDA on March 16.
The test has been clinically validated at several hospitals and clinical laboratories in both the U.S. and China, and clinical data published in the Journal of Medical Virology was among the world’s first for a COVID-19 serology test.
“The test 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,” Wang said. “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.”
The test recently received CE Mark-IVD certification for use in Europe and is being sold in Italy, a global hot spot for the outbreak.
The test is simple and quick to complete. A few drops of blood, collected with a lancet, are transferred to a test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative results.
TEST REVEALS PAST EXPOSURE
The test detects immunoglobulin M and G antibodies that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person didn’t exhibit any symptoms of the COVID-19 disease.
Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combatting COVID-19, the companies said in a news release announcing the test’s launch.
“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 Dave Hickey, president of Integrated Diagnostic Solutions for BD. “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.”
ONE PART OF COVID-19 TESTING ARSENAL
Hickey said BD’s 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.”
Current guidance from the FDA recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing may be considered to further evaluate the possibility of SARS-CoV-2 infection.
BioMedomics’ antibody test is “part of BD’s comprehensive approach to provide a full array of COVID-19 tests to customers,” said Troy Kirkpatrick, a BD spokesperson. The company recently announced a molecular test for use with its BD MAX System and is working on an antigen test for point-of-care applications.
“We don’t see this (antibody) test as a one-off offering for customers,” he said. “We want to provide access and choice for the right test (molecular/antigen/antibody) for the right situation.”
Health care providers can order the new antibody test and all collection devices needed to perform the test by contacting their BD or Henry Schein representatives, or by contacting Schein’s Medical Sales Department at 1-800-P-SCHEIN (800-772-4346); email at email@example.com; or fax at 1-800-329-9109.
BIOMEDOMICS SUPPORTED BY NCBIOTECH
BioMedomics was founded in 2006 to develop innovative point-of-care diagnostic solutions for underserved diseases and populations around the world. A $19,000 loan from the Biotech Center supported the start-up.
A $250,000 Small Business Research Loan in 2016 supported the company’s development of a low-cost, rapid point-of-care test for sickle cell disease, an inherited blood disorder. That test is now marketed as Sickle SCAN, an immunoassay that can distinguish between normal, carrier, and sickle cell disease samples within five minutes.
The company also markets Fungi SCAN, a reagent used in processing samples for the detection of fungal infections, and Femi SCAN, a staining agent used in the diagnosis of vaginal infections.
BD HAS OPERATIONS IN N.C.
BD, headquartered in Franklin Lakes, N.J., has more than 65,000 employees worldwide and a presence in most countries. It has four facilities in North Carolina: in Research Triangle Park, Durham, Mebane and Four Oaks.
BD is donating $750,000 to COVID-19 response efforts in the U.S. and internationally, in addition to the $350,000 in cash and product the company donated to COVID-19 relief efforts in China earlier this year.