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How the LDT Final Rule’s Exemptions Apply to Oncology Labs

How the LDT Final Rule’s Exemptions Apply to Oncology Labs

by Scott Wallask | Nov 7, 2024 | Compliance Perspectives-lca, Compliance-lca, Essential, FDA-lca, Lab Industry Advisor

Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines

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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test

FDA Watch: FDA Approves Enhanced Cologuard Cancer Test

by Ron Shinkman | Nov 1, 2024 | CDC-nir, Essential, FDA-lca, Lab Industry Advisor

Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent

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Esophageal Pre-Cancer Testing Gaining Greater Traction

Esophageal Pre-Cancer Testing Gaining Greater Traction

by Ron Shinkman | Oct 29, 2024 | Clinical Diagnostics Insider, FDA-dtet

How three companies are addressing screening challenges with tests that help improve chances of early detection

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Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible

Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible

by Ron Shinkman | Sep 25, 2024 | Clinical Diagnostics Insider, FDA-dtet

Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening

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Removing Restrictions to Germline Testing

Removing Restrictions to Germline Testing

by Oscelle Boye, MBiomed | Sep 23, 2024 | Clinical Diagnostics Insider, Emerging Tests-dtet

With the global cancer burden growing, is a universal germline genomic testing approach the key to more effectively combating the disease?

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