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UrduThe Association for Molecular Pathology published a joint consensus report with the Association of Public Health Laboratories that reviews and summarizes standard concepts and best practices for next-generation sequencing methods for SARS-CoV-2 genomic surveillance.
Tag: Molecular Diagnostics
International Lung Cancer Experts Seek Public Comments on Updated Molecular Testing Guideline to Improve Patient Selection and Targeted Therapies
The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced today the open comment period for the revised 2018 evidence-based guideline, “Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors.”
Association for Molecular Pathology Files Lawsuit Against FDA to Challenge Final Rule on Regulation for Laboratory Developed Testing Procedures
The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD, today announced the filing of a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that regulates laboratory developed test (LDT) procedures as medical devices under the Federal Food, Drug, and Cosmetic Act.
Hitachi High-Tech Acquires Majority Interest in Nabsys
Hitachi High-Tech Corporation (Hitachi High-Tech) and Nabsys 2.0 LLC (Nabsys) announced today that Hitachi High-Tech has acquired a majority interest in Nabsys, a developer and manufacturer of instrumentation and consumables for the analysis of genomic structural variation.
Wren Laboratories Unveils Dynamic Executive Leadership Team and 2024 Commercial Strategy Overhaul
Wren Laboratories announced executive leadership for commercial operations and market expansion. Dr. Abdel Halim is appointed CEO and CSO. Troy Tremaine Appointed to CCO, Dr. Eva Szarek Head of Marketing, and Melissa Ferone director of quality. Expansion includes AI-driven mRNA liquid biopsy genomic assays for biopharma and diagnostics.
Association for Molecular Pathology to Provide Preliminary Analysis of the FDA’s Final Rule on Laboratory Developed Testing Procedures
The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, will host a free webinar on the US Food and Drug Administration (FDA) final rule that seeks to regulate laboratory developed tests (LDTs) as medical devices.
Association for Molecular Pathology Appoints Lauren S. Menser as Chief Executive Officer
The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, today announced the appointment of Lauren S. Menser, CAE, as its Chief Executive Officer, effective January 3, 2024.
Association for Molecular Pathology Publishes Best Practice Recommendations for Liquid Biopsy Assay Validations
The Association for Molecular Pathology has published best practice recommendations for validating and reporting clinical circulating tumor DNA (ctDNA) or liquid biopsy assays and their related scientific publications.
A Leading-Edge Lymphoma Program
Less than three years after joining the Cedars-Sinai Cancer faculty, hematologist-oncologists Justin Darrah, MD, and Akil Merchant, MD, are pioneering new research and bringing a new, comprehensive set of treatment options to patients in the recently established Lymphoma Program.
AMP Assesses Clinical Implementation of Past Standards and Guidelines for Interpretation and Reporting of Sequence Variants in Cancer
The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, has published a report that was designed to assess clinical adoption, identify classification inconsistencies, and evaluate implementation barriers for the 2017 report, “Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer: A Joint Consensus Recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists.” The AMP manuscript, “Assessments of Somatic Variant Classification Using the AMP/ASCO/CAP Guidelines” was released online ahead of publication in The Journal of Molecular Diagnostics.
New Low-cost Device Rapidly, Accurately Detects Hepatitis C Infection
The entire virus detection process is executed inside a uniquely designed, portable, inexpensive, disposable, and self-driven microfluidic chip. The fully automated sample-in–answer-out molecular diagnostic set-up rapidly detects Hepatitis C virus in about 45 minutes and uses relatively inexpensive and reusable equipment costing about $50 for sample processing and disease detection. The disposable microfluidic chip also offers shorter times for a reliable diagnosis and costs about $2.
BioGX Launches CE-IVD Marked Multi-gene COVID-19 Point-of-Care Test at AACC
BioGX announced the launch of a point-of-care (POC) CE-Marked, three gene multiplex COVID-19 test on its pixl platform.
Open Lab Solutions Announces New Manufacturing Division to Initially focus on Medical Plastics
CHICAGO, July 26, 2022 /PRNewswire/ — AACC 2022 Open Lab Solutions, Inc., is announcing the formation of a new division, AMCAR Scientific, that will focus on an expanding product line of plastic consumables used in the medical industry. OLS is exhibiting within booth #3257 at the 74th American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Laboratory Exposition (AACC 2022) at the McCormick Place Convention Center in Chicago, July 24 – 28th.
Chicago and Rush partner to detect new strains of COVID-19 with new advanced lab
Rush University Medical Center is opening an advanced molecular laboratory that will examine COVID-19 samples from across the city to detect new strains of the virus for the Chicago Department of Public Health
Association for Molecular Pathology Reinforces Continued Commitment to Improving National Diagnostic Testing Response for Current COVID-19 Pandemic and Future Emerging Outbreaks
The Association for Molecular Pathology (AMP), the premier global, molecular diagnostic professional society, today announced the formation of the AMP COVID Response (ACR) Steering Committee to help coordinate and communicate the organization’s continued efforts to guide diagnostic testing during the ongoing COVID-19 pandemic and preparations for future emerging outbreaks.
Mesa Biotech to Launch Molecular, Sample-to-Answer RSV Test at the 2019 AACC Annual Scientific Meeting
Mesa Biotech Inc., a privately-held, molecular diagnostic company that has developed an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis, today announced the launch of its respiratory syncytial virus test (RSV). Mesa will demonstrate its expanded, novel Accula™ Test System at the 71st American Association of Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo. The Accula System’s RSV and Flu A/Flu B molecular tests will be on exhibit in Booth 3902. Sekisui Diagnostics distributes both products in the US under the Silaris™ brand.