Political support grows for new blood tests detecting multiple types of cancer

Dec. 2 Blood tests designed to detect multiple cancers at early stages are entering the market, and experts say political and financial momentum is growing for what may be a major leap forward in cancer diagnostics.

Interest in multi-cancer early detection (MCED) tests has surged since 2021, when GRAIL, a California-based biotech company, unveiled Galleri. The test claims to identify over 50 cancer types before symptoms appear, offering a window for more effective and potentially curative treatment.

Another MCED test, Cancerguard, was introduced in September by Exact Sciences of Madison, Wisconsin, and is now being promoted nationwide. Cancerguard similarly aims to detect 50 cancers and subtypes in one blood sample, including aggressive forms such as pancreatic, ovarian, liver, esophageal, lung, and stomach cancers.

Although these tests have not yet received FDA approval, they are available as "laboratory-developed tests," a classification that allows diagnostic tools to enter the market for conditions lacking other screening options.

Jody Hoyas, CEO of the Prevent Cancer Foundation, emphasizes that MCED tests could provide early warnings for cancers that currently lack effective screening, such as pancreatic and ovarian cancer.

However, the tests come with high costs and are not covered by insurance. Cancerguard, for example, is priced at $689 per test, limiting access to those who can afford it out-of-pocket. Still, the perceived potential of these tests to transform cancer prevention has sparked a growing push to integrate them into mainstream healthcare. Support is coming from healthcare companies, patient advocates, and U.S. lawmakers across party lines.

Efforts to secure Medicare coverage for MCEDs after FDA approval are nearing success. The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, named after Rep. Terri Sewells late mother, has gathered 400 co-sponsors and received unanimous approval from the House Ways and Means Committee. The bills supporters highlight the urgent need for policies that enhance cancer prevention, early detection, treatment, and patient support.

Hoyas notes that although Medicare coverage would carry costs, particularly from potential false positives, lawmakers understand the value of expanding screening options. Early detection equals better outcomes and is less expensive than treating advanced-stage cancers, she said.

The healthcare industry is also heavily investing in MCEDs. Exact Sciences was acquired by Abbott Laboratories for $21 billion, aiming to strengthen its position in cancer screening and precision oncology diagnostics. Cancerguard demonstrated 68% sensitivity for six of the deadliest cancers and high specificity at 97.4%, showing promise in reducing late-stage cancer diagnoses and overall mortality.

Dr. Tom Beer, Exact Sciences chief medical officer for MCED, says the tests expand screening to more than 50 cancer types, addressing cancers that currently lack recommended screening. He predicts that wider adoption of MCEDs will encourage earlier detection and greater access to care.

Both industry leaders and advocacy groups are pushing for Medicare coverage to make MCEDs accessible across income levels, while clinical evidence is being gathered for FDA approval. Hoyas envisions a future where cancer is increasingly viewed as a manageable chronic disease rather than a fatal diagnosis, potentially reshaping research, drug development, and treatment strategies to focus on early-stage intervention.

Author: Benjamin Carter