Exact Sciences has launched its long-awaited blood test designed to detect the early stages of multiple tumors, with a plan to sell it to consumers through a telehealth program in a bid to increase cancer screening rates.
The Cancerguard test can help spot the signs of more than 50 different types of malignancies, according to the company—excluding breast and prostate cancers but including aggressive diseases and those responsible for more than 80% of annual new diagnoses in the U.S., such as cancers of the pancreas, ovaries, liver, lungs, esophagus and stomach.
At the same time, Exact Sciences estimates that about 70% of yearly cases and deaths are linked to hidden tumors that currently have no recommended screening regimen. The test is designed for adults between the ages of 50 and 84 who have not received a cancer diagnosis within three years.
“Cancerguard builds on the legacy of Cologuard, which has delivered more than 20 million test results and transformed colorectal cancer screening,” CEO Kevin Conroy said in a statement. “Backed by strong science and developed to screen for many of the deadliest cancers, the Cancerguard test represents the next bold step in our mission to detect cancer earlier.”
Exact Sciences plans to offer Cancerguard as a laboratory-developed test, priced at $689, with results turned around within two weeks. It will first be available to physicians for prescription before it opens up broader consumer access through its own web portal next month.
The company has partnered with Quest Diagnostics to collect blood draws at its 7,000 patient access locations across the country as well as within oncology and primary care clinics and in users’ homes through mobile phlebotomy services.
Exact Sciences is also offering care navigator services, plus up to $6,000 in reimbursements for some non-covered PET or CT scans that may be required to follow up and confirm a positive result.
“The Cancerguard test offers a critical early warning that cancer may be present and helps inform an imaging-guided pathway to diagnosis, giving people the chance to act when it matters most,” said Tom Beer, M.D., Exact Sciences’ chief medical officer for multi-cancer early detection.
“As adoption grows, we’ll look back and ask how we ever settled for screening for only a few cancers while letting the majority go undetected,” said Beer. “Like the smartphone redefined communication, Cancerguard has the power to redefine cancer detection and the future of early intervention.”
The R&D behind the test has spanned nearly 10 years, including the work of the liquid biopsy developer Thrive Earlier Detection and its CancerSEEK program, which Exact Sciences acquired for $2.15 billion in 2020.
Cancerguard sifts the bloodstream for fragments of tumor DNA as well as proteins released from different organ sites. In previous studies, it posted a false-positive rate of less than 3%.
In terms of sensitivity, it reached 68% among the six aforementioned cancers, and 64% overall, though again excluding breast and prostate tumors. Cancerguard also identified more than a third of Stage 1 or 2 cases. The company projects that over a decade of use, the test could reduce late, Stage 4 diagnoses by as much as 42%, where treatments are limited.
Exact Sciences is also compiling a registry of 25,000 participants to collect real-world evidence around the test as part of a plan to submit Cancerguard for FDA review in the future and make the case for insurance coverage and inclusion in screening guidelines.
The company has billed 2025 as a transformative year for its business, following the launches earlier this year of its upgraded Cologuard Plus home test for colorectal cancer, as well as Oncodetect, a blood test for detecting minimal residual disease and recurrence following tumor treatments and surgery.