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ACLA

FDA, HHS Update COVID-19 Test Emergency Use Authorization Policies

The FDA said it intends to focus on specific EUA requests, while HHS withdrew a policy directing FDA not to enforce premarket review requirements for LDTs.

People in the News: New Appointments at Hologic, Akoya Biosciences, Caris Life Sciences, More

New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests
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While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves

The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.

Stakeholders Voice Concerns, Push Back on NCD for NGS Cancer Panels
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In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.  

Mar 27, 2019

CMS to Revisit National Coverage Determination on NGS Tumor Testing

Feb 1, 2019

Healthcare Stakeholders Ask CMS Not to Limit Access to NGS Hereditary Cancer Risk Tests

Jan 22, 2019

Labs, Advocacy Groups Push Back on Medicare Policy Shift on NGS Testing for Hereditary Cancer Risk
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Nov 15, 2018

FDA, Industry Willing to Collaborate on Dx Regulation via Legislation Despite Differences
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Jun 22, 2018

Some Stakeholders Not on Board With Draft Bill on New Dx Regulatory Framework
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May 4, 2018

FDA Recommends Precertification Program to Legislators as They Consider Dx Regulatory Reform

Mar 15, 2018

Industry Groups Lobby Congress Ahead of Final CMS National Coverage Policy on NGS Cancer Panels
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Feb 15, 2018

ACLA Seeks Summary Judgment in PAMA Lawsuit

Jan 5, 2018

Personalized Medicine Continued Growth in 2017 Despite Political, Reimbursement Uncertainty
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Dec 11, 2017

ACLA Files Lawsuit Challenging PAMA Rates

Sep 28, 2017

Lab Industry Fears Consolidation and Further Price Erosion if PAMA Prices Stick
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Sep 22, 2017

CMS 2018 PAMA Pricing Cut for Lab Tests Deeper Than Prior Estimate; Advanced Dx Lab Tests Fare Well

Jun 1, 2017

Lab Group Backs Draft Bill Proposing Dx Regulatory Reform; Finds Points of Agreement With FDA Paper
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Mar 30, 2017

CMS Will Give Labs More Time to Report PAMA-Required Payor Data

Mar 24, 2017

Lab Industry Group Asks CMS to Extend PAMA Implementation Timeline to 2019

Jan 17, 2017

FDA Releases Discussion Paper on LDT Regulation After Gathering Stakeholder Feedback
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Nov 18, 2016

FDA Holding Off on Finalizing Regulatory Guidance for Lab-Developed Tests

Jun 20, 2016

CMS Holding Off Market-Based Payment for Labs Until 2018; Tweaks Criteria for Labs Reporting Pricing

Mar 29, 2016

Legislators Urge CMS to Delay PAMA Implementation

Jan 28, 2015

Draft of 21st Century Cures Legislation Addresses Device Reforms, but Silent on LDTs

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The Scan

Study Examines Insights Gained by Adjunct Trio RNA Sequencing in Complex Pediatric Disease Cases

Researchers in AJHG explore the diagnostic utility of adding parent-child RNA-seq to genome sequencing in dozens of families with complex, undiagnosed genetic disease.

Clinical Genomic Lab Survey Looks at Workforce Needs

Investigators use a survey approach in Genetics in Medicine Open to assess technologist applications, retention, and workforce gaps at molecular genetics and clinical cytogenetics labs in the US.

Study Considers Gene Regulatory Features Available by Sequence-Based Modeling

Investigators in Genome Biology set sequence-based models against observational and perturbation assay data, finding distal enhancer models lag behind promoter predictions.

Genetic Testing Approach Explores Origins of Blastocyst Aneuploidy

Investigators in AJHG distinguish between aneuploidy events related to meiotic missegregation in haploid cells and those involving post-zygotic mitotic errors and mosaicism.