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Top Five Articles on 360Dx Last Week: AMP Petitions Congress; Universal Dx Funding; More

Last week, readers were most interested in a story about the Association for Molecular Pathology's petition to Congress about CLIA updates and LDTs.

AMP Petitions Congress to Revisit CLIA Update, Eyes Legal Action Against New Proposed FDA LDT Rule

While AMP asked members to register their opposition officially, one official said "there probably will be a lawsuit."

ChromaCode Lung Cancer Assay Shows Advantages in New Data at AMP as Company Eyes Next Applications
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The firm is working with early adopters of its NSCLC kit as it develops new tests for cancer minimal residual disease monitoring and kidney transplant rejection.

AMP: Roche Avenio Solid Tumor CGP Assay Shows Concordance With Other NGS-Based Assays
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A comparison for 144 solid tumor samples showed a "high degree of alignment" with FoundationOne CDx and better calling of CNAs than Illumina's TSO 500.

Proposed Medicare Coverage Criteria for Cancer Genetic Tests Alarm Industry Stakeholders
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Medicare contractors want to rein in inappropriate use of genetics tests, but lab and pathologist groups worry that new coverage requirements may limit access. 

Jul 10, 2023

Association for Molecular Pathology Releases CYP3A4 and CYP3A5 Genotyping Recommendations

Jun 19, 2023

Inex Innovate to Launch PCR-Based Endometrial Cancer Detection Test

May 18, 2023

AMP, NSGC Issue New Recommendations for Confirming Germline Variants From NGS Tests

Mar 29, 2023

Congress Revives LDT Regulation Efforts, but Prospects are Cloudy
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Nov 7, 2022

Pathologists Evaluate Implementation of PGDx Comprehensive Genomic Profiling Kit
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Nov 7, 2022

Thermo Fisher Introduces Homologous Recombination Deficiency Score for Cancer Profiling Assay
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Nov 3, 2022

UK Startup LEX Diagnostics Developing Ultra-Fast Low-Cost PCR for Infectious Disease Dx
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Oct 18, 2022

AMP, CAP Release Guidelines for Use of In Silico Approaches for Validating NGS Data Pipelines

Oct 6, 2022

Lab Orgs Call for CLIA Modernization to Handle LDT Oversight, but CMS Appears to Oppose Idea
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Sep 16, 2022

Fate of Existing LDTs Under VALID Act Questioned by Lab Stakeholders
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Aug 25, 2022

Senate Bill Proposes Bringing Back Patents on Genes
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Aug 25, 2022

VALID Act Divides Dx World as IVD Biz Welcomes Consistency, Flexibility While Labs Fear Red Tape
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Aug 8, 2022

CAP Weighs in on dMMR, MSI Assays for Immunotherapy Patient Selection
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Apr 19, 2022

AMP Offers Recommendations to CMS, HHS to Prepare for Next Pandemic

Jul 29, 2021

Association for Molecular Pathology Issues Guidelines to Promote Genetic Variant Data Sharing

Jun 10, 2021

AMP-led Expert Groups Release Clinical CYP2D6 Pharmacogenomic Testing Recommendation

Apr 21, 2021

AMP Cautions Against Using Cycle Threshold Values for PCR SARS-CoV-2 Tests in Clinical Practice

Mar 16, 2021

New AMP Survey Reports Insufficient Reimbursement for Analysis, Interpretation of MDx Test Results

Feb 23, 2021

AMP Survey Finds Significant Decline in Molecular Cancer Testing Due to COVID-19 Pandemic

Nov 20, 2020

Burning Rock Adds New Data Supporting Cancer Screening Liquid Biopsy, Automated NGS Products