Quest Diagnostics is slated to provide phlebotomy services in support of the Galleri multi-cancer early detection blood test, according to a news release.
Menlo Park, Calif.-based Grail completed enrollment for the Pathfinder prospective study of Galleri in clinical practice in December 2020. The 6,600-participant, multi-site, international study under an FDA investigational device exemption application has already completed its second planned independent data and safety monitoring board review and will have initial results, plus additional clinical validation data from a separate study, available in the first half of this year.
The company announced just last month that, following completed enrollment, it expects to introduce Galleri in the second quarter of this year. The blood test will be prescription only and will be available initially through partner health systems, medical practices and self-insured employers.
Under the agreement with Quest Diagnostics, which maintains approximately 2,200 patient service centers, Galleri will have its blood specimen collection provided by Quest’s phlebotomy network, comprised of 5,000 mobile phlebotomists in its ExamOne business. The collaboration will kick in once Galleri becomes available in the U.S. later this year.
“Today, the majority of cancers go undetected until too late when outcomes are often deadly, and we believe Galleri could offer a unique and potentially life-saving solution by finding multiple types of cancers earlier,” Grail chief medical officer & head of external affairs Dr. Joshua Ofman said in the release. “We are pleased to work with Quest and are very encouraged by the interest in Galleri. Our agreement with Quest will help us support convenient access to blood collection for patients and healthcare providers.”
“Quest Diagnostics is committed to providing the broadest access to diagnostic innovation. That includes multi-cancer early detection, an important area of oncology diagnostics with potential to radically improve cancer screening, monitoring, and treatment,” added Quest Diagnostics VP & GM of its oncology clinical franchise Kristie M. Dolan. “Galleri is a pioneer in early detection innovation, and we are eager to support Grail’s efforts to make it accessible to patients across the United States.”