entertainment -WSS

entertainment

author：focus 2025-09-06 03:54:55 - browse：21758

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： DIEP, the 'gold standard' of breast reconstruction, is under threat
Next article： Living with Hashimoto's and celiac disease, and med school, too

WSS

How to make Best Hospitals ratings actually useful for patients

Apellis safety probe of eye disease drug centers on injection needle

The pain doctors face in trying to build their families

As pharma fights Medicare drug negotiation, hospitals, docs silent

Unicorn down: Following layoffs, Biofourmis CEO quietly departs

Trump's false claims about Georgia's 2020 election long debunked

hotspot

entertainment

This article is exclusive to STAT+ subscribers

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

hotspot

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

FDA panel gives mixed vote on blood pressure devices

Trump demands the U.S. pay no more for drugs than other countries … again

Neuroscience startup Neumora files for IPO

Walensky prepares to leave CDC — and Congress — behind

Apellis safety probe of eye disease drug centers on injection needle

After affirmative action ruling, medical educators look to 'holistic review'

New definition of a human embryo proposed amid rapid advances

Medical leaders decry Supreme Court decision on affirmative action

As pharma fights Medicare drug negotiation, hospitals, docs silent

focus

Diversity in medical illustrations gets boost from Chidiebere Ibe

Radiation, mainstay of cancer treatment, begins a fade

Living with Hashimoto's and celiac disease, and med school, too

Trump cancels press conference intended to dispute Georgia election interference charges

Trump cancels press conference intended to dispute Georgia election interference charges

Apellis safety probe of eye disease drug centers on injection needle

entertainment

focus

focus

focus