Biodesix, Inc. to oversee onsite surveillance testing of Quidel Corporation’s rapid
SOFIA 2 SARS Antigen FIA test
All involved in close contact Big Ten Conference sport competition to receive Quidel rapid antigen
surveillance testing with additional validity testing through the Biodesix Laboratory
ROSEMONT, Ill. - The Big Ten Conference has entered into strategic partnerships with Biodesix, Inc., a leading diagnostic company with a focus on lung disease, and Quidel Corporation, the manufacturer of the FDA authorized SOFIA 2 SARS rapid antigen test. Biodesix will oversee and manage the onsite testing of the Quidel antigen test while additionally validating with the Bio-Rad SARS-CoV-2 Droplet Digital™ PCR (ddPCR™) test. This partnership will provide comprehensive surveillance testing for SARS-CoV-2 (the virus that causes COVID-19) for all student-athletes and staff personnel involved in close contact sports competition. Those individuals who are presumptively positive based on the results of the antigen surveillance testing will be referred to their respective member institutions’ health staff for confirmatory PCR testing.
“Along with its medical and scientific capabilities as a certified laboratory, Biodesix is committed to helping the Big Ten meet the testing requirements and reporting protocols established by the medical subcommittee and adopted by the Big Ten Council of Presidents and Chancellors (COP/C),” said Dr. Jim Borchers, Head Team Physician, The Ohio State University, and co-chair of the Big Ten Conference Return to Competition Task Force medical subcommittee.
“Along with its medical and scientific capabilities as a certified laboratory, Biodesix is committed to helping the Big Ten meet the testing requirements and reporting protocols established by the medical subcommittee and adopted by the Big Ten Council of Presidents and Chancellors (COP/C),” said Dr. Jim Borchers, Head Team Physician, The Ohio State University, and co-chair of the Big Ten Conference Return to Competition Task Force medical subcommittee. Dr. Borchers added, “Quidel’s rapid antigen testing technology represents the ability to perform COVID-19 surveillance testing on a large scale with prompt results.”
The Return to Competition testing will begin on September 30, 2020. Biodesix administrators will be on site this week at each of the 14 Big Ten campuses, coinciding with the first shipment of the rapid antigen testing kits from Quidel. Biodesix and its designated contractor, Maxim Healthcare Staffing Services, Inc., will assume all day-to-day sample collection and surveillance testing responsibilities.
“The partnership with Biodesix and Quidel is an important step toward achieving our mission of keeping our student-athletes, and the communities that support them, healthy and safe,” said Big Ten Commissioner Kevin Warren. “The data we are scheduled to collect, and the research component of this partnership, will provide major contributions to all 14 Big Ten institutions as they study COVID-19 and attempt to mitigate the spread of SARS-CoV-2 (the virus that causes COVID-19) among wider communities.”
All Big Ten Conference student-athletes and staff personnel involved in close contact sports competition will be administered Quidel’s rapid antigen surveillance test prior to every practice and game. Maxim Healthcare Staffing Services personnel will administer the Quidel Sofia 2 SARS Antigen FIA test on-site.
“We are pleased to be partnering with the Big Ten to provide daily testing for its student-athletes, while also expanding the largest research initiative into asymptomatic individuals,” said Douglas Bryant, president and CEO of Quidel Corporation. “In addition to supporting the return to play for student-athletes, this research is key to understanding the virus and improving the testing algorithm to defeat it."
Presumptively positive results of antigen testing for Big Ten student-athletes and others included in the team testing protocols will be referred to their member institution’s health staff for confirmatory PCR testing. Each university’s Chief Infection Officer will report confirmed positive cases to the medical subcommittee of the Big Ten Conference Return to Competition Task Force. Decisions to alter or postpone practice or competition will be based on tests and population positivity rates of each institution's teams. Additionally, Biodesix will perform validity ddPCR testing on a percentage of anonymous samples from individuals with negative antigen test results to provide data for the medical subcommittee to ensure that the rapid antigen tests are performing in accordance with expectations.
“We are honored to work with these world-class institutions to protect their exceptional student-athletes and the staff who support them,” said Scott Hutton, CEO of Biodesix. “We admire and share the resilience and determination that the Big Ten has shown during the effort to build such a robust system of testing protocols. This initiative underscores our commitment to the health and safety of this community and to helping prevent the spread of COVID-19.”
All COVID-19 positive student-athletes will undergo comprehensive cardiac testing to include labs and biomarkers, ECG, Echocardiogram and a Cardiac MRI. Following cardiac evaluation, student-athletes must receive clearance from a cardiologist designated by the university for the primary purpose of cardiac clearance for COVID-19 positive student-athletes. The earliest a student-athlete can return to game competition is 21 days following a confirmed positive diagnosis.
On Wednesday, September 16, 2020, the Big Ten Council of Presidents and Chancellors (COP/C) adopted significant medical protocols including daily antigen testing, enhanced cardiac screening and an enhanced data-driven approach when making decisions about practice and competition. The COP/C voted unanimously to resume the football season starting the weekend of October 23-24, 2020. The decision was based on information presented by the Big Ten Return to Competition Task Force, a working group that was established by the COP/C and Commissioner Warren to ensure a collaborative and transparent process.
The Big Ten Conference (bigten.org) is an association of world-class universities whose member institutions share a common mission of research, graduate, professional and undergraduate teaching and public service. Founded in 1896, the Big Ten has sustained a comprehensive set of shared practices and policies that enforce the priority of academics in the lives of students competing in intercollegiate athletics and emphasize the values of integrity, fairness and competitiveness. The broad-based programs of the 14 Big Ten institutions will provide over $200 million in direct financial support to more than 9,800 students for more than 11,000 participation opportunities on 350 teams in 42 different sports. The Big Ten sponsors 28 official conference sports, 14 for men and 14 for women, including the addition of men’s ice hockey and men’s and women’s lacrosse since 2013.
Biodesix (biodesix.com) is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood-based Nodify Lung™ nodule risk assessment testing strategy consisting of the Nodify XL2™ test and the Nodify CDT™ test evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.
Quidel Corporation (quidel.com) serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. As an industry leader in the introduction of FDA-authorized rapid tests for a wide range of diseases and medical conditions, Quidel is playing a leading role in the effort to develop rapid, reliable, accessible, and innovative testing for COVID-19, including the first to market FDA EUA approval of the
Sofia® SARS Antigen FIA rapid test. Quidel’s research and new product development engine is what has historically fueled its growth by developing a continuum of diagnostic tests from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare not only in physicians’ offices, hospitals and reference laboratories but in emerging markets such as pharmacies, nursing homes and educational institutions. For more information about Quidel’s comprehensive product portfolio, and to explore exciting
employment opportunities, visit quidel.com.
Jordona Jackson Smith for Biodesix