Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced it has joined with eighteen organizations from the healthcare community to form the COVID-19 Testing Industry Consortium. Consortium members will work together to increase opportunities to accelerate research through enhanced collaboration and information sharing, with the ultimate goal of improving aspects of COVID-19 testing across the globe.

Widespread accurate testing for SARS-CoV-2, the virus that causes COVID-19, is one critical aspect needed to limit the spread of the disease. By creating the COVID-19 Testing Industry Consortium, 19 organizations from the healthcare industry have joined forces with a goal to help inform, improve, innovate and accelerate various aspects of testing, ranging from research to clinical diagnostic applications.

Ortho Clinical Diagnostics offers two FDA Emergency Use Authorized SARS-CoV-2 antibody tests to help communities and laboratories battle the COVID-19 pandemic—the VITROS® Anti-SARS-CoV-2 Total test and the VITROS® Anti-SARS-CoV-2 IgG test. 

“Now is the time for the leaders in the diagnostics industry to come together and leverage the exceptional power of our expertise, science, R&D, manufacturing and other key areas to help bring this devastating pandemic to a swift end,” said Chockalingam “Palani” Palaniappan, chief innovation officer, Ortho Clinical Diagnostics. “Ortho is proud to bring to market high-quality, reliable, accurate COVID-19 tests and stand alongside likeminded organizations as a founding member of the COVID-19 Testing Industry Consortium.”

The consortium brings together a diverse group of companies with synergistic areas of expertise, including precision medicine, diagnostics, occupational health, pharmaceuticals and clinical testing laboratories, to help provide clarity and potential solutions to COVID-19 testing challenges. To advance the goals of the consortium, members may:

• Share relevant expertise, materials and experiences to accelerate understanding of COVID-19.
• Analyze available scientific and health data, materials and information to develop, improve and deploy current assays and new approaches for the COVID-19 testing paradigm.
• Contribute knowledge gained from the collaborative research by publishing work that will inform the scientific community and general public of the consortium’s findings.

“To uncover innovative ways to improve COVID-19 testing quickly during this global pandemic, it’s critical that we break down silos and bring together researchers from different organizations with complementary areas of expertise,” said Saurabh Saha, M.D., Ph.D., senior vice president, Translational Medicine, Bristol Myers Squibb. “This is just one of the many ways that the healthcare community is working together to help solve the COVID-19 pandemic. BMS is proud to lead this consortium and we look forward to building upon the important work that’s already been done in this space.”

The consortium was organized and is led by Bristol Myers Squibb. Consortium members include: 

• Alnylam Pharmaceuticals, Inc. 
• ArcherDx, Inc.
• Biocartis NV
• Color
• Diaceutics, PLC
• DxTerity Diagnostics, Inc.
• Genosity, Inc.
• Hematogenix Laboratory Services
• Infinity BiologiX
• Interpace Pharma Solutions, Inc.
• Janssen Pharmaceutica, NV
• LabCorp
• NeoGenomics Laboratories, Inc.
• Novartis Institute for BioMedical Research
• Ortho-Clinical Diagnostics, Inc.
• Syngene International Limited
• Takeda Pharmaceutical Company Limited ("Takeda")

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. 

The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved.  They have been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.  The  VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.