FDA moves to bring multibillion-dollar medical test industry under full government scrutiny [Fortune]
Quest Diagnostics Incorporated (DGX)
Last quest diagnostics incorporated earnings: 4/22 06:45 am
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Source: Fortune
The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable. “The final rule announced today aims to provide crucial oversight of these tests to help ensure that important health care decisions are made based on test results that patients and health care providers can trust,” said FDA commissioner Robert Califf, in a release. Califf said inaccurate tests can lead to unnecessary treatment or delays in getting proper care. But in a significant move, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review. The agency said it will essentially grandfather those tests into approval to address concerns that the new
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DGX
Earnings
- 4/23/24 - Beat
DGX
Sec Filings
- 5/1/24 - Form 4
- 4/29/24 - Form 144
- 4/26/24 - Form 4
- DGX's page on the SEC website