STERLING, VA — May 21, 2020 — Aperiomics, a leader in infectious disease diagnostics, today announced that the company has partnered with Antibody Biopharm, Inc. to validate and begin use of an innovative rapid antibody test for the coronavirus that causes COVID-19, pairing the offering with its existing Xplore-COVID-19™ RT-PCR testing platform. Using its CLIA-certified laboratory, Aperiomics has validated this new test which can detect antibodies indicating immunity to the novel coronavirus in just 15 minutes. The highly sensitive and specific COVID-19 IgM/IgG antibody test is currently available for use in any CLIA-certified laboratory with proper internal validation, with FDA authorization pending for use at point-of-care.
The test provides a tool to help identify those who have been exposed to the COVID-19 virus (aka coronavirus, specifically SARS-CoV-2) and can be especially helpful in identifying those who have recovered from asymptomatic or mildly symptomatic cases. As communities, businesses, schools and other organizations move towards reopening and loosening social distancing restrictions, testing for both current infections and immunity will be critical to keeping people safe and minimizing the spread of the disease. The COVID-19 IgM/IgG Antibody Test can be ordered individually or paired with Aperiomics’ Xplore-COVID-19™ RT-PCR—providing a comprehensive toolkit for medical professionals testing for both COVID-19 infection and immunity.
“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 Dr. Crystal Icenhour PhD, CEO of Aperiomics. “By offering both Xplore-COVID-19™ RT-PCR and COVID-19 IgM/IgG Antibody testing, we can better serve health providers, patients and public health systems that need this information as we enter the next phase of this pandemic. 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.”
The COVID-19 IgM/IgG Antibody test was developed by Antibody Biopharm, Inc.—a Maryland-based biotechnology startup focused on the research of groundbreaking antibody technologies. The testing platform utilizes COVID-19 IgM/IgG Detection Cassettes that can determine the presence of COVID-19 antibodies in plasma samples with 98 percent sensitivity and 99.9 percent specificity. The test can identify both early (IgM) and late-stage (IgG) antibodies, providing results within days of initial infection and for months or years after exposure. While the highly accurate test can determine the presence of early antibodies, negative results do not fully rule out COVID-19 infection in cases where there is a delay in the patient’s immune response. For this reason, it is recommended that antibody tests be coupled with other clinical observations such as clinical symptoms and RT-PCR tests to capture a fuller picture of the coronavirus.
“We are proud to work with the team at Aperiomics and contribute to the fight against COVID-19. The launch of this rapid antibody test will give patients, health care providers and public health officials vital information about the coronavirus and much needed peace of mind,” said Dr. Yongjun Guan, cofounder of Antibody BioPharm, Inc. “This is one of several innovative solutions being brought to market by Antibody BioPharm, Inc. as we continue to research and develop new ways to fight COVID-19 and other viral outbreaks.”
Per FDA regulations, COVID-19 samples for Aperiomics’ testing must be collected by a healthcare provider. Aperiomics utilizes a cough throat swab for viral Xplore-COVID-19™ RT-PCR testing and a plasma sample for the COVID-19 IgM/IgG Antibody test. Aperiomics has submitted an FDA EUA (for emergency use) application for the Xplore-COVID-19™ RT-PCR Test. Aperiomics partnered with Antibody BioPharm, Inc. to validate the COVID-19 IgM/IgG antibody test and Antibody Biopharm, Inc. has submitted an FDA EUA application for this test.Both tests have been validated at Aperiomics and other clinical laboratories and clinical sample testing can be performed in our CLIA-certified laboratory, but FDA’s independent review of this validation is pending. Upon successful review by FDA, this COVID-19 IgM/IgG Antibody test will be available for point of care use by trained health care professionals.
Medical professionals interested in ordering COVID-19 testing from Aperiomics should contact the company at firstname.lastname@example.org or 703-229-0406.