A global resource for the development and validation of diagnostics
SEATTLE, August 25, 2020 – The current pandemic showcases a critical need to accelerate the development and validation of quality diagnostic products for COVID-19. To support this effort, PATH, a global health non-profit, has created a biorepository of qualified clinical samples to support and accelerate the development and validation of quality in-vitro diagnostics.
With support from the Bill & Melinda Gates Foundation, PATH has been coordinating with clinical partners across the Seattle area since the beginning of the pandemic to create a catalogue of inactivated virus and clinical samples, including nasal swabs, tongue swabs, nasopharyngeal swabs, serum, and plasma to assist developers in the verification and validation of diagnostic tests. These clinical samples include those collected from patients with a confirmed diagnosis of COVID-19 using an FDA EUA COVID-19 RT PCR diagnostic test.
“The value of a diagnostic depends on how well it works and how confident we can be in the results. A standard pool of qualified, pedigreed sets of clinical samples provides an opportunity to compare tests and identify those best suited for use in a particular environment,” explained Roger Peck, Senior Program Officer for PATH Diagnostics. “We can also understand how tests might work together or help troubleshoot challenges we see as they are deployed in the health system.”
Due to the unique and limited nature of these samples, a governance committee will review all submissions to help prioritize the use of samples for tests that are intended for global markets and that can be manufactured at scale. This governance committee also guides the scientific, ethical, and legal use of the biorepository’s samples.
PATH is a global nonprofit dedicated to achieving health equity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, health, economics,
technology, advocacy, and dozens of other specialties, PATH develops and scales up solutions to the world’s most pressing public health challenges.