Guardant Health’s blood-based multi-cancer screening test receives FDA Breakthrough Designation

Multi-cancer screening test receives FDA Breakthrough Designation: ©TrueffelPix -stock.adobe.com

Guardant Health Inc. has received Breakthrough Device designation from the U.S. Food and Drug Administration for its Shield multi-cancer detection test, a blood-based screening tool designed to detect multiple types of cancer in average-risk adults aged 45 and older.

The Shield MCD test uses methylation-based analysis to screen for cancers including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreatic. The FDA grants Breakthrough Device designation to technologies that may offer more effective diagnosis or treatment for life-threatening diseases, such as cancer, and aims to expedite their development and review.

“Every late-stage cancer we avert is a win for patients and for the entire healthcare system,” said AmirAli Talasaz, Guardant Health co-founder and co-CEO. “This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw.”

The Shield MCD test was previously selected by the National Cancer Institute for the Vanguard Study, which evaluates emerging multi-cancer detection technologies. At this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, Guardant presented validation data showing the Shield test demonstrated 98.6% specificity and 75% sensitivity across eight cancer types. Its accuracy in identifying the tissue of origin was 92%.

Progress in cancer screening

The FDA’s Breakthrough Device designation for Guardant Health’s Shield test comes amid a wave of innovation in cancer screening, particularly around non-invasive, blood-based diagnostics known as “liquid biopsies.” These tests aim to detect cancer early by identifying DNA fragments shed by tumors into the bloodstream—offering a promising alternative to traditional methods like colonoscopy or mammography.

Several companies are racing to bring multi-cancer detection tests to market, driven by emerging data suggesting these blood tests can identify cancers that currently lack routine screening protocols, such as pancreatic and ovarian cancer. Unlike single-cancer tests, MCD tools may allow for broad population screening using one blood draw, improving early detection rates while potentially reducing unnecessary invasive procedures.

In addition to Guardant Health, other companies, such as GRAIL (developer of the Galleri test), are also undergoing large-scale trials, and researchers are closely watching how these tests integrate into clinical practice.

Beyond technology, health care systems and policymakers are beginning to examine how to integrate these innovations into routine care. The Centers for Medicare & Medicaid Services is exploring reimbursement pathways, and organizations like the National Cancer Institute are funding large trials to establish evidence on outcomes and cost-effectiveness.

As screening moves toward broader accessibility and precision, the challenge will be ensuring that the benefits of early detection extend equitably across populations—while minimizing false positives and overdiagnosis.