Bipartisan legislation aims to overhaul the PAMA rate-setting process that has cut $4 billion in cuts to clinical laboratory services in three years, according to ACLA.
Labguru completed the SOC 2 Type 2 examination, demonstrating a commitment to high standards of security, privacy, and confidentiality.
CLP Editor Chris Wolski examines the need for LDT regulations, and issues an industry-wide call to action.
AMP is urging medical organizations to contact their elected officials to remove the VALID Act from a 2023 “omnibus” appropriations bill.
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The FDA has updated its COVID-19 test policy to ensure continued access to tests, transitioning traditional premarket review pathways.
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The Centers for Medicare & Medicaid Services issued a proposed rule that would update the CLIA 1988 fee regulations.
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Erika Cheung and Tyler Shultz—two of the key Theranos whistleblowers—will speak in a special fireside chat at AACC 2022.
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The AACC joins more than 100 other organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act.
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In CLP’s July cover story, we’re examining how the proposed VALID regulations will affect the laboratory industry and society as a whole.
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The bipartisan VALID Act would implement a risk-based review system for all diagnostic tests, including LDTs, under the FDA.
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As the bipartisan VALID Act moves closer to a vote, the potential regulation could impact the future of laboratory-developed tests (LDTs).
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The College of American Pathologists warns the No Surprises Act will further drive more physicians out of their patients’ health plan networks.
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To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems is giving access to a CLIA laboratory.
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Certain temporary deviations in FDA policy in response to the COVID-19 pandemic may offer a blueprint for regulatory oversight of LDTs.
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Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test is for use on the cobas Liat System. The false positive results may be related to two issues observed by Roche.
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The i.C3 monitors the temperature inside a laboratory refrigerator or freezer and activates alarms if the temperature rises or falls outside of the acceptable range.
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COLA’s Waived Testing Toolkit provides guidance and tools to help staff achieve and maintain waived testing excellence, including guidance on covid-19 reporting.
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The new guidances for medical product developers, specifically covering vaccines, diagnostics, and therapeutic products, address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes covid-19.
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