WuXi Diagnostics Collaborates with Thermo Fisher and Mayo Clinic to Develop SARS-CoV-2 Serology-Based Antibody Test Kit

SHANGHAI, May 14, 2020 /PRNewswire/ -- WuXi Diagnostics Lab (Shanghai) Co., Ltd. (hereinafter referred to as "WuXi Diagnostics Lab") announced that it has partnered with Thermo Fisher Scientific (hereinafter referred to as "Thermo Fisher," NYSE: TMO) and Mayo Clinic to co-develop serology-based antibody test kits for the novel coronavirus.

Currently, countries around the world are intensifying their efforts in COVID-19 testing. WuXi Diagnostics Lab has successfully developed an antibody test kit (using the enzyme-linked immunosorbent assay method) that can specifically detect total antibodies and IgG antibodies against SARS-CoV-2, and it is compatible with open testing platforms. Clinical validation conducted by Mayo Clinic has confirmed the high specificity, sensitivity, and accuracy of this test kit. In the coming weeks, Thermo Fisher Scientific will apply for Emergency Use Authorization (EUA) from the U.S. FDA as well as other international regulatory approvals.

“Since the pandemicOutbreak“Since then, our scientific, regulatory, and commercial teams have been actively engaged in viral analysis and identification, deployment of personal protective equipment, and the development of therapeutic regimens and vaccines,” said Marc N. Casper, Chairman, President, and Chief Executive Officer of Thermo Fisher Scientific. “To halt the spread of the novel coronavirus, it is essential to implement comprehensive testing solutions. We are pleased to collaborate with WuXi Diagnostics Lab (Shanghai) Co., Ltd. and Mayo Clinic to meet the widespread demand for SARS-CoV-2 antibody testing. Through this joint effort, we can provide new testing solutions to governments, healthcare systems, and communities, thereby supporting the fight against the COVID-19 pandemic.”

Due to variations in disease course and severity among patients with COVID-19, the window period for viral detection can differ. Therefore, it is essential to combine nucleic acid testing based on PCR technology with serological antibody testing. Nucleic acid testing serves as the "gold standard" for diagnosing novel coronavirus pneumonia, while serological testing determines whether an individual carries antibodies against the virus, thereby verifying prior or ongoing infection and assessing immune response establishment. Combined testing assists clinicians in providing targeted diagnosis and treatment for patients in both the acute and recovery phases.

Thermo FisherThe kit, named Thermo Scientific OmniPath COVID-19 Total Antibody ELISA, will go into production at its U.S. and European facilities in the coming weeks.

“WuXi Diagnostics Lab is delighted to join forces with Thermo Fisher Scientific, a global leader in scientific services, and Mayo Clinic, a world-renowned medical institution. This global collaboration, encompassing R&D, clinical practice, manufacturing, and commercialization, will significantly advance the clinical application of COVID-19 serological testing,” stated Dr. Liu Fujun, CEO of WuXi Diagnostics Lab. “We remain committed to leveraging technological innovation to contribute to the global fight against the pandemic, and we look forward to fostering further collaborations on WuXi Diagnostics Lab’s open empowerment platform to deliver integrated diagnostic solutions for patients and healthcare providers worldwide.”

“This marks a significant milestone in COVID-19 testing and is the result of close collaboration among industry partners,” said Dr. Gianrico Farrugia, President and Chief Executive Officer of Mayo Clinic. “The full integration of Thermo Fisher Scientific’s commercialization capabilities, WuXi Diagnostics Lab’s R&D expertise, and Mayo Clinic’s clinical and laboratory testing capabilities will rapidly enhance access to high-quality testing.”