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FDA Proposal for LDTs Risks Serious Consequences

FDA Proposal for LDTs Risks Serious Consequences

by Gail Dutton | Oct 18, 2023 | Essential, FDA-lir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.

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Which Test? Choosing the Best Approach to Diagnosing Rare Disease

Which Test? Choosing the Best Approach to Diagnosing Rare Disease

by Michael Schubert, PhD | Sep 28, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet, Testing Trends-dtet

Genomic sequencing is almost twice as likely to yield a diagnostic result, but lags behind panel testing in speed, cost, and concordance.

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Pursuing the PFAS Problem

Pursuing the PFAS Problem

by Michael Schubert, PhD | Sep 27, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Legislation-dtet, Testing Trends-dtet

Tackling the challenges of “forever chemicals” in the diagnostics industry.

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Diagnostic Error: What Harm Can It Do?

Diagnostic Error: What Harm Can It Do?

by Michael Schubert, PhD | Aug 29, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Inside the Diagnostics Industry-dtet

Research reveals that diagnostic error in the US may cause up to 800,000 serious outcomes annually.

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Addressing the Challenges of Bile Acid Diarrhea Diagnosis

Addressing the Challenges of Bile Acid Diarrhea Diagnosis

by Michael Schubert, PhD | Jul 31, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet

A new five-metabolite blood test designed by algorithm could simplify and speed up this challenging diagnosis.

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