top of page

Cancer Detection Testing with Potential to Identify 50 Cancer Types

Aubrie Graegin
9 hours ago
3 min read
Courtesy of Cleveland Clinic.
Courtesy of Cleveland Clinic.

On February 4, 2026, World Cancer Day, Congress signed the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection (MCED) Act. This legislation allows the Centers for Medicare and Medicaid Services to cover MCED tests, once FDA approval is obtained. 


MCED tests are breaking through to the healthcare market, with the potential to reduce 21% of cancer-related deaths by early screening. MCED tests work by analyzing a single blood draw to look for multiple cancer types in one lab. These tests screen for abnormal cells that could indicate cancer in a patient, with further testing required when an abnormality is detected. MCED testing can also assist in locating where cancer may be originating from, allowing for follow up tests to be more precise. 


These tests are coming at a vital time. Approximately 70% of cancer deaths happen from cancers that do not have a standard screening method. In fact, only 14% of cancers even have recommended screening methods. In the U.S. alone, it is estimated that 626,140 die from cancer yearly, and cancer is the number one global cause of death. 


MCED tests in development are working to identify up to 50 different cancer types, closing the current gap in cancer detection. 72.8% of those cancer types detected in a PATHFINDER 2 study, the large-scale study evaluating GRAIL’s MCED test, were associated with cancers that do not currently have screening guidelines. Traditional cancer screening methods are very specific and generally only test for one cancer type at a time, making MCED testing extremely cutting-edge. 


The financial burdens that come with late-stage cancers could also be minimized with earlier detection. Late-stage cancer treatment can cost up to 10 times more than treatment for cancer at its earliest stage. MCED could potentially lower cancer treatment costs by detecting earlier stage cancer and allowing people to receive treatment before extreme progression. 


“In general, cancer progression is lower and survival is much higher when people are treated at an early stage,” says Harvard’s Director of Multi-Cancer Early Detection Clinic, Dr. Elizabeth O’Donnell. 


The major setback to these tests is the question of how early they can actually detect cancer. It is still unknown at what stage tumors will start producing DNA that can be successfully traced in biomarkers. 


MCED is also not entirely reliable when it comes to false positives, which can create unnecessary emotional distress for patients mistakenly flagged for abnormalities.  


“Ensuring the accuracy and reliability of these tests to minimize false positives should be a top priority to avoid undue patient stress,” says Health Services Researcher Robert Volk.


MCED tests have yet to be FDA approved, but the FDA has still acknowledged the benefits of this technology. While still in a prospective stage, the FDA has granted Natera’s MCED assay with a breakthrough device designation, entering the device into a special program for speeding up the development of life-saving technology. In an FDA approval vote for GRAIL’s Galleri MCED test, the FDA unanimously voted that their test was safe. The voting process also questioned effectiveness and whether the potential benefits of MCED testing outweighs the risk. The majority of the panel also voted in favor of both factors, but a final approval from the FDA has still yet to come.  


Despite lack of FDA approval, many MCED tests are currently available without insurance coverage. They can cost upwards of $950. 


Though unclear whether these tests will receive FDA approval, MCED testing shows a lot of promise for patients seeking early assurance about cancer diagnoses.The logical next steps for MCED testing is refining the test’s accuracy, administering clinical trials, and securing FDA approval.



Comments


bottom of page