fashion -WSS

fashion

author：explore 2025-09-28 10:52:36 - browse：92472

Courtesy Guardant Health

An independent panel of advisers to the Food and Drug Administration recommended the agency approve Guardant Health’s blood-based colon cancer detection test. If the agency follows the recommendation, it will clear an early hurdle for the test’s broader adoption.

The expert panel spent hours listening to presentations from Guardant, the FDA, and members of the public before voting on the screening test, called Shield. The panel’s nine voting members then voted on whether the test was safe, effective, and whether its benefits outweigh its risks, with eight, six, and seven panelists endorsing those views, respectively.

FDA approval is a requirement for winning coverage from the Centers for Medicare and Medicaid Services, which could be the difference between Guardant’s test becoming widespread — or irrelevant. In 2021, CMS denied coverage for Epi proColon, a different blood-based colon cancer test approved by the FDA. Soon after, the test’s maker, Epigenomics, announced that it would stop actively marketing the test, and last year the company announced a restructuring that included layoffs.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Walensky prepares to leave CDC — and Congress — behind
Next article： Americans' trust in science, scientist continues decline: Report

WSS

The woman behind the Dana Farber

Eli Lilly expects to double planned employment in Boston center

FDA approves world's first CRISPR

AbbVie buys Immunogen, maker of targeted cancer drugs, for $10B

Medicare reduced heart disease by changing how it pays doctors

The EU Joint Clinical Assessment needs to live up to its promise

focus

fashion

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

hotspot

Affirmative action in medical school literally saved lives

NIH confirmation hearing shows politicization of research

Virginia high school admissions case could be legal follow

Americans' trust in science, scientist continues decline: Report

Novavax promises a turnaround & Lilly roils the obesity market

Roche to buy Carmot Therapeutics, developer of obesity drugs

In age of alternative facts, a scholarly course on calling out crap

Eli Lilly expects to double planned employment in Boston center

Activists slam private health insurers over coverage restrictions

Why health workers in Gaza are injured or die at high rates

focus

STAT Event – Decoding Clinical Trials: Venture Capitalists Talk Early Biotech R&D

First Opinion Podcast: Long Covid needs a new approach

Spinal cord stimulation reduces pain in amputees, study finds

FDA struggles to regulate food additives, sometimes for decades

STAT letters to the editor on burnt

Solve the antibiotic resistance crisis with preventive drugs

Wikipedia

hotspot

Wikipedia

explore