The pilot program evaluates a clinical workflow for blood-based molecular diagnostics between British Columbia and Washington.
YD Bio Limited has launched a six-month pilot program in collaboration with Numia Health Inc to evaluate a cross-border clinical workflow for physician-ordered, blood-based cancer testing in British Columbia, Canada.
The pilot program is designed to assess an integrated clinical pathway that includes physician access, certified mobile blood collection, cross-border specimen logistics, and laboratory testing. The initiative is initially limited to 50 patient episodes in the Lower Mainland region of British Columbia and supports OkaiDx blood-based laboratory-developed tests (LDTs) for breast, colorectal, pancreatic, liver, and gastrointestinal cancers.
Under the agreement, Numia Health will coordinate physician requisitions, mobile blood collection, specimen preparation, and logistics. Laboratory analysis will be performed by EG BioMed US Inc at its Clinical Laboratory Improvement Amendments-certified, College of American Pathologists-accredited laboratory in Bothell, Washington.
“This collaboration reflects our strategy of expanding patient access to advanced molecular diagnostics through strong healthcare partnerships,” says Ethan Shen, CEO of YD Bio, in a release. “Through this pilot, we aim to evaluate a scalable cross-border testing workflow that is designed to broaden access for patients while maintaining the laboratory quality and regulatory standards that underpin our platform.”
The initiative represents the first structured clinical-access program in Canada for YD Bio. The company intends to evaluate the operational workflows, specimen logistics, and patient experience to determine the scalability of the cross-border model before considering broader commercial collaborations.
The OkaiDx tests are LDTs performed exclusively at the EG BioMed US laboratory at the request of a prescribing healthcare provider. According to the company, these tests have not been cleared or approved as medical devices by the Food and Drug Administration or Health Canada and are offered according to requirements governing laboratory-developed tests.
