The partnership addresses the unique challenges facing schools in the following ways:
• Given the precious resources of schools public and private, the test will be offered at an affordable price and less than the COVID-19 clinical diagnostic reimbursement price announced in April for Medicare Part B for high throughput, technician intensive, and time intensive tests. The partnership is also investigating the possibility of offering pooled pricing for schools that perform regular testing, once an initial baseline has been established. This approach could incorporate pooled testing, where test samples are batched - potentially reducing analytical costs.
• Given the need to test both students and employees, the sample collection will use CentoSwab, Centogene’s validated, CE-labeled, ethylene oxide-treated swabs and collection tubes that can ship directly to school sampling locations. This FDA listed, class 1 medical device is an oropharyngeal swab and does not require a medical expert, a stabilization buffer, or specialized kits.
• Given the need for accuracy, the testing will use RT-PCR and will be conducted at a Centogene lab, certified by the College of American Pathologists and as a CLIA lab, authorized to do moderate to complex diagnostics required for PCR testing.
• Given the time-pressure around the beginning of the school year in August and September, up to 50,000 tests per week are available for this partnership at this time and can be increased upon demand. All logistics for sample collection will be handled by Centogene and its logistics partners to ensure sample collection, delivery, and analysis in a timely manner.
• Given the importance of ensuring the highest levels of privacy and data protection, the schools will not be providing identifying information to Centogene or OESIS on who the samples came from, rather a simple numerical identifier on the swab container that will be accessed by the school using a digital web portal. It will be the responsibility of the schools to inform those who would have tested positive, as well as other required disclosures to local health authorities.
“Centogene has all the operational attributes we were looking for including reputation, quality, capacity, logistics and price,” said Sanje Ratnavale, president, OESIS Network. “We were drawn to its experience and credentials testing high school students and teachers already for COVID-19, who provided us with the necessary references. Although many of the schools in our network are independent, this program will be equally available to public and Title 1 schools, particularly if they are able to access Cares Act funding potentially for such uses.”
Jennifer Zaccara, head of school at the Vermont Academy in Saxtons River, VT, said, “OESIS simply ‘went to bat’ for schools when they needed support. As a result, we now have access to COVID-19 testing at affordable rates.”
Robert de Deugd, senior vice president of global sales, Centogene, said, “To overcome this global pandemic, it is vital that we work together to create worldwide solutions – preventing a further outbreak and enabling students to continue to focus with their educational journey. Working alongside the OESIS Network, we will be able to provide highly validated, precise testing to schools throughout the U.S. We are very enthusiastic that this initiative will enable students and staff to return to the classroom, while continuously keeping their health, safety, and peace of mind at the forefront.”