Wikipedia -WSS

Wikipedia

author：knowledge 2025-09-28 23:11:37 - browse：75

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： At least 13 dead in Texas as scorching temps continue
Next article： Sanofi to acquire U.S. biotech Inhibrx in $2.2 billion deal

knowledge

leisure time

WSS

Experimental asthma app from Apple and Anthem shows promise

Cancer diagnosis changes perspective doctor, former hospital CEO

FDA reorg will put new emphasis on investigations, sources say

First transplant of an entire human eye performed

TikTok, Instagram influencers need more rules for drug ads

High breast density mammograms need follow

entertainment

Wikipedia

This article is exclusive to STAT+ subscribers

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

entertainment

Medical leaders decry Supreme Court decision on affirmative action

Maisha Meds is a PBM, but don't call it that

Walensky prepares to leave CDC — and Congress — behind

What health policies could hitch a ride on a spending bill?

Medical leaders decry Supreme Court decision on affirmative action

Head of FDA's diagnostics center, who led through Covid, retires

New Eli Lilly Alzheimer’s data poses Medicare coverage conundrum

Immunocompromised patients offer clues on chronic Covid

What does generative AI mean for health care? We asked experts

FDA reorg will put new emphasis on investigations, sources say

leisure time

A letter from the executive editor: STAT UnitedHealth investigation

Medical school prerequisites are outdated

CVS, Rite Aid closures threaten to worsen pharmacy deserts

Experimental asthma app from Apple and Anthem shows promise

FDA reorg will put new emphasis on investigations, sources say

The inclusion problem at the heart of rehabilitation research

Wikipedia

knowledge

leisure time

focus