ArcherDx plans to seek FDA approval for Stratafide as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve the underutilization of targeted therapies in late-stage cancer patients.
“Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital’s molecular diagnostic laboratory,” says Jason Myers, chief executive officer and cofounder of ArcherDx. “Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data, and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 US hospitals and health systems and approximately 175,000 other providers.”
ArcherDx and Premier’s research team will identify retrospective samples from patients with colorectal, lung, or thyroid cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate Stratafide as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.
“Our partnership with ArcherDx demonstrates the expanse of Premier’s research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings,” says Stella A. Safo, MD, MPH, chief clinical transformation officer and vice president for Premier Applied Sciences. “We hope this research will help accelerate appropriate cancer care for hard-to-reach populations, and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities.”