Grail Inc. is teaming up with Quest Diagnostics Inc. to support the upcoming launch of its multicancer blood test. The early cancer detection test, called Galleri, is slated to begin rolling out in the second quarter of 2021.

Secaucus, N.J.-based testing behemoth Quest has 2,200 patient service centers, as well as a network of 5,000 mobile phlebotomists who can provide at-home blood collection services under its Examone business. The phlebotomy network will help to collect blood samples for Galleri once the test becomes available in the U.S.

“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,” said Joshua Ofman, chief medical officer and head of external affairs at Menlo Park, Calif.-based Grail. “Our agreement with Quest will help us support convenient access to blood collection for patients and health care providers.”

PATHFINDER, CCGA studies

In December 2020, Grail completed enrollment in PATHFINDER, a prospective, 6,600-subject, multisite interventional IDE study to assess the implementation of Galleri in clinical practice. The study recruited adults age 50 and older for screening in primary care settings and is following them for 12 months through any ensuing cancer treatment.

PATHFINDER has completed a second planned independent data and safety monitoring board review, and initial results of that study, as well as additional clinical validation from Grail’s foundational Circulating Cell-free Genome Atlas (CCGA) study, are expected in the upcoming months. The combined data are intended to support Grail’s introduction as a laboratory-developed test (LDT).

Last March, Grail reported results from a sub-study within its more than 15,000-patient CCGA study showing its test detects 43.9% of stage 1 to stage III cancers across 50 cancer types, with a higher detection rate of about 67.3% in a prespecified set of 12 of the deadliest cancers in that stage range. The company anticipates that its liquid biopsy assay could be particularly helpful in detecting the most aggressive cancers, which shed large quantities of genetic material into the bloodstream.

Quest’s offers testing and support services to about half of all physicians in the U.S., and about one in three American adults receive services each year, Kristie Dolan, vice president and general manager of Quest’s Oncology Clinical franchise, told BioWorld. “Collaborations such as the one formed between Quest Diagnostics and Grail are exciting because they open up far greater opportunities to reach patients with cutting-edge innovations, such as Galleri, that hold the potential to greatly improve care and outcomes.”

Rx-only, LDT test launching soon

The test is expected to launch this summer as a prescription-only LDT. It is also expected to be available to eligible patients in the U.K. later this year via a partnership with the National Health Service to support a long-term program for earlier cancer diagnoses.

Grail won breakthrough status from the U.S. FDA for the test in 2019, allowing for more frequent communications with agency staff as it completes its clinical studies and prepares a premarket approval application.

A 2016 spin out of Illumina Inc., Grail has raised nearly $2 billion big-name investors with promises of a blood test for early cancer detection. In October, San Diego-based Illumina announced plans to reacquire the liquid biopsy startup for $8 billion, giving it a major stake in the race to develop a less-invasive way to diagnose cancer.

The deal, which has been approved by both companies’ boards, is expected to close in the second half of the year.

Last year, Grail announced an expansion in Durham, N.C., with plans for a state-of-the-art laboratory facility, office and warehouse space. “We anticipate that as our products gain broader adoption and we develop additional products, we will utilize the Durham laboratory to meet commercial demand and research and development needs,” a Grail spokesperson told BioWorld.

The company has an active pipeline of future products. In addition to Galleri, Grail is developing a diagnostic aid for cancer (DAC) test meant to speed diagnosis for people for whom there is a clinical suspicion of cancer. Also in the works is a minimal residual disease test designed to enable blood-based detection with or without tissue.