PISCATAWAY, New Jersey and WEST SACRAMENTO, Calif., April 13, 2021 /PRNewswire/ — Molecular Matrix, Inc. (MMI) and GenScript Biotech Corp. announced today that they have partnered to offer GenScript’s SARS-CoV-2 neutralizing antibody test to the public via physician screening. GenScript’s cPass™ SARS-CoV-2 Neutralization Antibody Detection Kit is the first test authorized by the U.S. Food and Drug Administration to detect neutralizing antibodies (NAbs), the specific antibodies present in the serum of COVID-19 patients that are responsible for blocking the viral infection and widely regarded as biomarkers of immunity.
“This collaboration brings neutralizing antibody testing to the public for the first time, via physician screening, and could be a valuable tool for consumers as vaccines are rolled out nationwide,” said Michael Lau, PhD, director of corporate strategy at GenScript. “Doctors and patients may access this novel test to monitor neutralizing antibodies after recovery from COVID-19 or immunization. In addition, convalescent plasma treatment centers may use the service to determine whether donated plasma is appropriate for COVID-19 treatment.”
MMI provides COVID-19 PCR testing to physicians, patients and companies through its CLIA-certified lab in West Sacramento. The company has implemented high-throughput cPass testing, and is capable of screening hundreds of samples for neutralizing antibodies each day. The company is also developing an automated platform to significantly increase throughput. MMI is in discussion with clinics and companies across the US to accept samples for cPASS testing.
“Our collaboration with GenScript provides an important tool for understanding immunity against SARS-CoV-2 post-recovery or post-immunization,” said MMI CEO Charles Lee, PhD. “We are pleased to partner with GenScript to offer neutralizing antibody tests to our communities.”
The cPass test has also been authorized for emergency use by the FDA’s Center for Biologics Evaluation and Research (CBER) for convalescent plasma screening. In addition, the test is CE marked, and Emergency Use Authorized by Health Sciences Authority of Singapore, ANVISA in Brazil and Ministry of Health and Prevention in the United Arab Emirates.
Employing novel technology invented by Professor Wang Linfa, director of Duke-National University of Singapore’s Emerging Infectious Diseases program, and team, the cPass kit is the first neutralizing antibody test that does not require the use of live virus. Traditional virus neutralization tests require live virus and cells and must be performed in a biosafety containment facility staffed by highly skilled personnel, with results often taking days. The cPass kit enables detection of neutralizing antibodies within an hour, without the need for live virus and biosafety containment, making it broadly available to standard labs in hospitals and clinics.
The test has been validated with samples of patients from PROTECT, a multi-centered Prospective Study to Detect Novel Pathogens and Characterize Emerging Infections, coordinated by Singapore’s National Centre for Infectious Diseases and granted Singapore’s Health Sciences Authority’s (HSA) provisional authorization for clinical use.
For more information about cPass testing at MMI, please contact the company at [email protected].
About GenScript Biotech Corporation
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Built upon its leading gene synthesis technology, GenScript is divided into four major platforms including the life science contract research organization (CRO) platform, the biologics contract development and manufacturing organization (CDMO) platform, the global cell therapy platform and the industrial synthesis biological product platform.
About Molecular Matrix Inc.
Molecular Matrix Inc. (MMI) is a biotechnology company that began as a startup at UC Davis, and has successfully developed and commercialized a synthetic hyper-crosslinked carbohydrate polymer (HCCP) for tissue engineering. MMI’s synthetic bone graft substitute, Osteo-P® BGS, has been producing favorable clinical outcomes for patients since its launch in 2018. Since October 2020, MMI has been providing reliable COVID-19 RT-PCR testing through its CLIA certified laboratory in West Sacramento.
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