StockNews.AI
GH
StockNews.AI
77 days

FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test

1. Guardant Health's Shield MCD test receives Breakthrough Device designation from FDA. 2. This designation enhances market potential across various cancer types for GH.

2m saved
Insight
Article

FAQ

Why Very Bullish?

The Breakthrough Device designation increases commercialization chances, similar to past success stories in biotech.

How important is it?

The Shield MCD test’s FDA designation positions GH competitively in the oncology market.

Why Long Term?

The breakthrough status can lead to broader clinical adoption and revenue growth over time.

Related Companies

NVODGXEXAS
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 4.

Related News