New blood test detects multiple cancers at early stages
Exact Sciences' Cancerguard now available in US for $689
A new blood test capable of detecting multiple cancers at earlier, more treatable stages is now available in the U.S. for $689, its developer said.
Exact Sciences said the test, Cancerguard, is the first of its kind, analyzing multiple biomarkers in a single blood sample to detect more than 50 cancer types, including hard-to-find cancers often diagnosed at later stages when treatment options are limited. It builds on the company’s Cologuard stool test for colorectal cancer screening, which is broadly covered by insurers and recommended in U.S. guidelines since its approval in 2014.
“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,” Kevin Conroy, chairman and CEO of Exact Sciences, said in a company press release. “With deep, trusted relationships across the health care system, Exact Sciences has the reach, credibility, and commitment to bring earlier answers to more people. This is the moment where we begin to change the course of cancer forever and give people power over their futures.”
The company has partnered with Quest Diagnostics, which will offer blood collection at about 7,000 patient service centers nationwide, as well as in participating primary care and oncology clinics and through mobile at-home services. Exact Sciences said the test is recommended for adults aged 50 to 84 without a cancer diagnosis in the past three years. Results are available within two weeks, and if cancer signals are detected, guidance on follow-up imaging and financial assistance will be provided.
Capturing early signals
When cancer develops, tumor cells release DNA fragments and certain proteins into the bloodstream, which can sometimes be detected before symptoms appear or the disease advances.
Guideline-recommended screening programs, however, currently exist for only a handful of cancers, leaving the majority without established early detection methods. According to Exact Sciences, nearly 70% of annual cancer cases and deaths in the U.S. occur in cancers with no recommended screening.
Blood-based tests like Cancerguard are designed to capture these early cancer signals, with the goal of finding cancers at their earliest and most treatable stages.
Data from development studies showed the test achieved about 64% sensitivity, meaning it correctly identified cancer in about two-thirds of people who had the disease, across six of the most aggressive cancers with the lowest five-year survival rates: pancreatic, esophageal, liver, lung and bronchial, stomach, and ovarian cancers. Overall sensitivity was 68% across a broad range of cancers, including those without screening options.
The test also detected more than one-third of stage 1 or 2 cancers, showing its potential to identify disease in early stages when treatments are most effective. Reported specificity was 97.4%, meaning the test correctly ruled out cancer in most people who did not have the disease.
To further evaluate Cancerguard’s performance in everyday practice, Exact Sciences has launched the Falcon Real-World Evidence Registry (NCT06589310). The company is enrolling up to 25,000 adults, aged 50–80, who have not had a cancer diagnosis in the past three years. Participants will undergo annual testing for three years and be followed for five years.
The company said data from the study will help with future regulatory approvals, support insurance coverage and reimbursement discussions, and guide efforts to add the Cancerguard test to clinical guidelines.
“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, MD, chief medical officer at Exact Sciences. “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. Like the smartphone redefined communication, Cancerguard has the power to redefine cancer detection and the future of early intervention.”
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