Survey: Proposed FDA Approval of Laboratory Developed Tests Will Reduce Innovation

Though response was limited in Dark Daily’s poll, the message from respondents was overwhelmingly negative on LDT regulation by the FDA Most respondents to a recent industry survey said that should Food and Drug Administration (FDA) approval be required in the future for laboratory developed tests (LDTs), innovation will suffer. This conclusion echoes what opponents of the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) have argued will happen should that proposed bill...

Former FDA Commissioner Scott Gottlieb to Headline Artificial Intelligence in Healthcare and Diagnostics Conference

Gottlieb will speak about the state of AI in healthcare at the event May 11-12 Medical technicians in clinical laboratories and pathology groups may worry that artificial intelligence (AI) will eventually put them out of their jobs. However, that’s not likely to be the case, according to former Food and Drug Administration (FDA) Commissioner Scott Gottlieb. He was just announced as a top speaker at the Artificial Intelligence in Healthcare and Diagnostics (AIHD) Conference, which takes place...

Kennedy Targets Home Brew Tests by Introducing Laboratory Test Improvement Act

Senators Edward M. Kennedy (D-MA) and Gordon H. Smith (R-OR) yesterday introduced a bill in the Senate that aims squarely to control laboratory-developed tests, also known as ‘home brew” tests. The trigger for this bill is the growing role of genetic technology in laboratory testing. Also, the appearance of Web sites purporting to sell genetic tests directly to consumers has created a concern in some quarters that regulation of laboratory tests can help keep scam artists and bad science out of...
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