FDA Declines to Appeal Court Ruling on LDT Oversight
Today's Clinical Lab, Association for Molecular Pathology
AMP President Jane S. Gibson, PhD, affirms the court ruling calling it a win for patients, innovation, and molecular pathology
Articles by Association for Molecular Pathology
AMP Releases Series of Reports Defining Core Bioinformatics Competencies for Clinical Diagnostic Laboratories
Association for Molecular Pathology
The three papers outline roles and required skills for bioinformaticians with respect to molecular diagnostics, clinical bioinformatics, clinical laboratory regulation, and data security
Texas Court Strikes Down the FDA's Proposed Regulation of Laboratory-Developed Tests
Association for Molecular Pathology
The FDA LDT rule would have imposed unnecessary burdens on laboratories, adding requirements beyond existing CLIA regulations
AMP Publishes Joint Consensus Report on SARS-CoV-2 Genomic Surveillance for Hospitals and Public Health Laboratories
Association for Molecular Pathology
The review is authored by a multidisciplinary team of experts from AMP and APHL, including the SARS-CoV-2 Whole Genome Sequencing Working Group
International Lung Cancer Experts Seek Public Comments on Updated Molecular Testing Guideline to Improve Patient Selection and Targeted Therapies
Association for Molecular Pathology
The open comment period begins August 22 and will close on September 12, 2024
Association for Molecular Pathology Challenges FDA in Lawsuit against Final Rule on Laboratory-Developed Test Regulation
Association for Molecular Pathology
Drastic policy change will stifle diagnostic innovation, impose billions of unnecessary dollars in healthcare mandates, and threaten patient access to essential medical procedures
AMP Releases Liquid Biopsy Assay Validation Recommendations
Association for Molecular Pathology
New joint consensus manuscript from AMP developed in collaboration with ASCO and CAP
AMP's Clinical Recommendations for CYP3A4 and CYP3A5 Genotyping
Association for Molecular Pathology
New consensus guideline builds on previous efforts to standardize testing and enable highest quality health care
Recommendations for In Silico Approaches for Validating NGS Analysis Pipelines
Association for Molecular Pathology
Latest joint consensus guideline authored by representatives from AMP and College of American Pathologists
Improving Diagnostic Testing Response for Current and Future Outbreaks
Association for Molecular Pathology
Article lays foundation for testing strategy that promotes collaboration between public health and diagnostic labs
AMP Publishes Recommendations to Facilitate Adoption of Data Sharing Practices
Association for Molecular Pathology
Robust variant data sharing through public repositories will help address health inequities
Minimum Set of Alleles Recommended to Guide CYP2D6 Genotype Testing
Association for Molecular Pathology
AMP report provids recommendations to aid in the design and validation of clinical CYP2D6 assays
Preliminary Results of Nationwide SARS-CoV-2 Molecular Testing Survey Released
Association for Molecular Pathology
More than 100 clinical laboratory professionals across the US provided feedback on COVID-19 diagnostic testing environment
AMP Addresses Clinical Relevance of DNA Variants in Chronic Myeloid Neoplasms
Association for Molecular Pathology
New report recommends minimum of 34 critical gene inclusions for high-throughput pan-myeloid sequencing tests to help standardize clinical practice and improve patient care