MCED - Big News for Cancer Screening and Early Detection

Following President Trump’s signature, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act is now law, establishing a new Medicare benefit category for MCED tests and creating a clear pathway to meaningful coverage once MCED tests are FDA approved (Link).

This is a major milestone, and I want to highlight a few reflections:

1) A remarkable achievement by Grail and MCED supporters

MCED is one of the most exciting frontiers in precision medicine. The ability to detect cancer signals through blood-based screening represents years of innovation in genomics, bioinformatics, and translational science, and tremendous collaboration across academia, industry, and clinical research.

2) A win for patients, especially where screening options do not exist

Roughly two-thirds of cancers still have no standard-of-care (SOC) screening. That gap costs lives. MCED has the potential to expand access to early detection for cancers that are often found too late.

3) FDA review remains essential and key scientific questions remain

Coverage policy is a huge step forward, but clinical performance and real-world use cases still need to be validated and refined. Some important questions the scientific and clinical community may need to help address include:

• For cancers with existing SOC screening, should MCED be used as an initial screen, or as a complementary test (e.g., SOC first, MCED as an add-on)?

• Since sensitivity for certain SOC-screened cancers may be lower than SOC, how do we ensure MCED does not unintentionally reduce detection by replacing established screening?

• With tissue-of-origin prediction not perfect (even at ~90% accuracy), what is the best clinical pathway when a cancer signal is detected but follow-up workup at the predicted site is negative?

These are not reasons to slow down. They are exactly the kind of questions that will strengthen the field and make implementation safer and more effective.

4) Reimbursement will accelerate innovation and ultimately benefit patients

A predictable reimbursement pathway will spur more developers to invest, more studies to be conducted, and more evidence to be generated. The science will improve, the tests will get better, and most importantly, patients will benefit from broader adoption of early detection.

This is an exciting moment for cancer screening. The work continues, but today is worth celebrating.