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LDTs Around the World

LDTs Around the World

by Michael Schubert, PhD | Jun 4, 2024 | Enforcement-lca, Essential, Lab Industry Advisor, LDTs-lir, Legislation-lca, Top of the News-lir

Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions

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Roche Scores First European IVDR Approval for Diagnostic Tests

by Glenn S. Demby | Jan 26, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.

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Heart Attack Diagnostics Market to Be Worth More than $22B in a Decade

Heart Attack Diagnostics Market to Be Worth More than $22B in a Decade

by Rachel Muenz | Oct 31, 2022 | Essential, Industry Buzz-lir, Laboratory Industry Report

Increasing incidences of heart disease, as well as technological advances, will drive growth over the next eight to 10 years, reports say.

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Infectious Disease Test Segment Poised for Strong Growth

Infectious Disease Test Segment Poised for Strong Growth

by Glenn S. Demby | Jul 29, 2022 | News, Open Content

The market is expected to grow at a CAGR of 3.21 percent from 2021 to 2028 and reach $17.432 billion by 2028, according to a recent report.

Three New Monkeypox Testing Solutions Launched

Three New Monkeypox Testing Solutions Launched

by Rachel Muenz | Jun 29, 2022 | News, Open Content

Two PCR assays and a PCR point-of-care solution from three different companies aim to help with diagnosing cases, tracking new variants.

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