Exact Sciences Corp., a leader in cancer diagnostics, has officially announced the launch of Cancerguard™ test, which happens to be a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States.
According to certain reports, Cancerguard arrives on the scene as first MCED test commercially available capable of analyzing multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.
To understand the significance of such a development, we must take into account how more than 70 percent of annual cancer cases and deaths in the U.S. occur due to cancers with no recommended screening.
Against that, the Cancerguard test is designed with a simple blood draw mechanism to detect signals from cancer types responsible for more than 80 percent of annual U.S. cancer diagnoses, including some with the highest mortality rates, such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers.
From a statistical standpoint, the Cancerguard test can detect more than 50 cancer types and subtypes.
“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 Dr. Tom Beer, chief medical officer for multi-cancer early detection 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.”
Talk about the whole value proposition on a slightly deeper level, we begin from how Exact Sciences’ will be delivered through the company’s expansive commercial and operational infrastructure, including a national sales force that engages primary care physicians, oncologists, and leading health systems.
In fact, to support patient access, Exact Sciences has also entered into an agreement with Quest Diagnostics to enable blood collection at the company’s approximately 7,000 patient access sites across the U.S., including through its patient service centers and in-office phlebotomists across provider offices, as well as mobile phlebotomy services for at-home collections.
The given diagnostics solution is also supported on the back of data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial.
 In case that wasn’t enough, Exact Sciences is now actively enrolling up to 25,000 participants in the Falcon registry, a real-world evidence study conducted under a U.S. FDA-reviewed Investigational Device Exemption (IDE). This comprehensive body of evidence informs future regulatory submissions, supports payer discussions on coverage and reimbursement, and guides efforts to include the Cancerguard test in clinical guidelines.
Cancerguard also integrates seamlessly into existing workflows and electronic medical records (EMRs). It is further backed by industry-leading care navigation support, spanning dedicated support for patients with positive results.
At launch, it is recommended for individuals aged 50-84 with no known cancer diagnosis in the past three years and can be considered annually. As for the pricing, it settles around $689 and may be eligible for flexible spending and health savings account use, with payment plans available.
Another detail worth a mention is rooted in the fact that Exact’s Cancerguard test delivered 68 percent sensitivity across six of the deadliest cancers and 64 percent overall sensitivity across a broader range of cancers. It also found more than a third of stage I or II cancers validating its ability to detect disease when it’s most treatable.
Apart from that, the test achieved high specificity of 97.4 percent, minimizing false positives and avoiding unnecessary procedures.
“Cancerguard builds on the legacy of Cologuard, which has delivered more than 20 million test results and transformed colorectal cancer screening,” said Kevin Conroy, chairman and CEO of Exact Sciences. “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. With deep, trusted relationships across the health care system, Exact Sciences has the reach, credibility, and commitment to bring earlier answers to more people.”
