Sterling’s Aperiomics Inc. has teamed up with Gaithersburg biotech Antibody Biopharm Inc. to offer a rapid antibody test for Covid-19.
The Loudoun County diagnostics startup has used its existing testing platform — the same tech involved in its own testing kits — in its Northern Virginia lab to validate and, now, begin offering the test to other laboratories that meet Clinical Laboratory Improvement Amendments, or CLIA, requirements. Aperiomics has been working with Antibody Biopharm since March.
But the partners still need a nod from the Food and Drug Administration to administer the test as a point-of-care diagnostic given by doctors and other health care providers, which Aperiomics said it expects within two months.
Under the deal, Aperiomics will be guaranteed a supply of test devices to purchase from Antibody Biopharm, minus the cost of its work to validate the tests, a spokesman for the Sterling startup said in an email Thursday. Those tests would then be sold to the CLIA-certified labs and health care providers after landing that necessary regulatory stamp.
“In order to effectively contain this virus, we must know two things: 1) who is currently infected and 2) who has immunity. Testing for one without the other gives us an incomplete picture of how fast the virus is spreading,” said Aperiomics CEO Crystal Icenhour in a statement.
By offering Aperiomics’ testing kits and this antibody diagnostic, “we can better serve health providers, patients and public health systems that need this information as we enter the next phase of this pandemic,” Icenhour said. “Aperiomics has been proud to be part of the response to this pandemic and utilizing our CLIA-certified laboratory, we have been able to ensure that this validation work meets and exceeds current FDA requirements, resulting in COVID-19 tests that are extraordinarily accurate.”
Testing remains a vital component of mitigating the pandemic, amid efforts to reopen economies and workplaces. And this particular antibody test — which the companies claim can detect Covid-19 antibodies within 15 minutes, with 98% sensitivity and 99.9% specificity — has the potential to help confirm exposure to Covid-19, Aperiomics said Thursday. Still, whether coronavirus antibodies would prevent reinfection remains uncertain.
The companies also note that a negative test wouldn’t rule out coronavirus infection; for instance, if there’s a delay in a patient’s immune response to the virus.
Aperiomics is separately working with Howard Hughes Medical Institute’s Janelia Research Campus in Ashburn, whose staff is volunteering its time and lending Aperiomics supplies and equipment to speed up its work on its Covid-19 testing kits. It’s also working with a strategic partner, a lab in Maryland, to take overflow testing, Icenhour said last month, declining to disclose further details.
That test costs $99 per sample, down from an initial $250 apiece. It should also be reimbursed by Medicare and private insurance providers.
