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Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

by Ron Shinkman | Mar 11, 2025 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet

The PCR-driven test provides results in about 20 minutes in non-laboratory settings

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MeMed Sepsis Test Gains Breakthrough Device Designation

MeMed Sepsis Test Gains Breakthrough Device Designation

by Ron Shinkman | Jan 31, 2025 | Essential, FDA-lca, Lab Industry Advisor

The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026

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Reimbursement Top Challenge for Labs in 2025

Reimbursement Top Challenge for Labs in 2025

by Rachel Muenz | Jan 23, 2025 | Essential, Inside the Lab Industry-lir, Lab Industry Advisor

ACLA president Susan Van Meter discusses some of the key issues labs faced in 2024, along with work to address these developments through 2025

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Which Recent FDA Webinars Are Most Useful for the LDT Rule?

Which Recent FDA Webinars Are Most Useful for the LDT Rule?

by Tara Cepull, MA | Jan 22, 2025 | Compliance Perspectives-lca, Essential, FDA-lca, Lab Industry Advisor

Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1

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FDA Watch: How Could the Change in US Government Affect IVDs and Labs?

FDA Watch: How Could the Change in US Government Affect IVDs and Labs?

by Rachel Muenz | Jan 6, 2025 | Essential, FDA-lir, Lab Industry Advisor

Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing

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