FDA approves newborn screening test for DMD
January 2020—The FDA authorized marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit, the first test to aid in newborn screening for Duchenne muscular dystrophy.
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Tuesday, November 10, 2026, 1:00 PM-2 PM ET
Join us for a session to help improve diagnostic accuracy in your practice when scoring HER2 IHC 0 with faint, incomplete membrane staining in ≤10% of tumor cells vs IHC 0 with no membrane staining detected in patients with mBC.
Webinar presenter Samuel Caughron, MD, FCAP, Chief Strategy Officer, MAWD Pathology, Medical Director of Laboratory, AdventHealth Kansas City, Medical Director of Laboratory, Labcorp, President, Member & Director, Pathology Ventures, LLC
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Monday, November 16, 2026, 12:30 PM-2 PM ET
Hear experts discuss a multidisciplinary approach to oncopathology for HER2
assessments for solid tumors in the absence of a companion diagnostic.
Webinar presenters Funda Meric-Bernstam, MD, Chair, Department of Investigational Cancer Therapeutics Medical Director, Institute for Personalized Cancer Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas, and Emina E. Torlakovic, MD, PhD, College of Medicine, University of Saskatchewan, Canadian Biomarker Quality Assurance, Saskatoon, Saskatchewan, Canada, and Carol Cheung, MD, PhD, JD, FRCPC, Deputy Director, Canadian Biomarker Quality, Assurance—Programme canadien d’assurance de la qualité des biomarqueurs
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, November 18, 2026, 12:00 PM-1 PM ET
Join leading pathology experts, Savitri Krishnamurthy, MD, and Marilyn Bui, MD, PhD, for a webinar exploring potential challenges in HER2 IHC testing for breast cancer, emerging evidence supporting digital and computational pathology as assistive tools for pathologists in HER2 IHC assessment, and practical considerations for real-world implementation and adoption.
Webinar presenters Savitri Krishnamurthy, MD, Professor of Pathology, Department of Anatomical Pathology The University of Texas MD Anderson Cancer Center, Houston, Texas, and Marilyn Bui, MD, PhD, Surgical Pathologist and Cytopathologist Member and Professor, Departments of Pathology, Machine Learning, and Translational Pathology, Scientific Director, Analytic Microscopy Core Chair, Women in Oncology Executive Board Moffitt Cancer Center, Tampa, Florida
CAP TODAY does not endorse any of the products or services named within. This program is being sponsored by Daiichi Sankyo, Inc. and AstraZeneca. The speakers are being compensated for their presentations. The program is not CME accredited and may not be used for CME credit.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, December 9, 2026, 12 PM-1 PM ET
Hear an expert pathologist discuss the role of HER2 IHC testing and scoring in solid tumors including endometrial, ovarian, cervical, bladder, non-small cell lung, colorectal, and biliary cancers
Webinar presenter Michelle Shiller, DO, MSPT, Baylor Sammons Cancer Center; Fulgent Genetics; Texas Cancer Interception Institute
CAP TODAY does not endorse any of the products or services named within. This program is intended for US healthcare professionals. This program is being sponsored by AstraZeneca. The speaker is being compensated for the presentation. The program is not CME accredited and may not be used for CME accreditation.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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DiaSorin introduces primer pair for Candida auris
January 2020—DiaSorin Molecular has released a primer pair that targets Candida auris, for use in laboratory-developed molecular tests. Candida auris is often multidrug resistant and has caused recent outbreaks in hospitals and long-term care facilities across the U.S. and in more than 20 countries, the company reports. The primer pairs are classified as analyte-specific reagents, which can be used by high-complexity laboratories to develop their own LDTs. DiaSorin Molecular, 562-240-6500
FDA approves second drug to prevent HIV infection
January 2020—The FDA approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35 kg (approximately 77 lbs.) for HIV-1 pre-exposure prophylaxis to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. (Descovy is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex, the company reports, because the effectiveness in this population has not been evaluated.)
Qiagen expands immuno-oncology portfolio
January 2020—Qiagen announced a series of agreements that expand its immuno-oncology assets for future commercialization of novel companion diagnostics, in particular based on next-generation sequencing technology. The agreements include a collaboration with Tokyo-based Repertoire Genesis that will provide access to novel technologies for the development of T-cell/B-cell receptor repertoire assays for use on NGS systems.
FDA clears Lumipulse G whole PTH assay
January 2020—Fujirebio Diagnostics received FDA clearance for its Lumipulse G whole PTH assay for testing on the Lumipulse G1200 immunoassay platform. The assay can be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from calcium metabolism disorders. The fully automated assay has a reaction time of 30 minutes and uses a single test cartridge. It has demonstrated excellent precision with a coefficient of variation of ≤4.0 percent, the company reports.
Validate kits for Roche, Siemens analyzers
January 2020—LGC Maine Standards released its Validate LP2 linearity and calibration verification kits for Roche Cobas analyzers. The kits evaluate apolipoprotein A (Apo-A1) and apolipoprotein B (Apo-B). Validate SP1 linearity and calibration verification kits, specifically targeted for Roche Cobas and Roche Cobas Integra analyzers, were also released. The kits evaluate α1-antitrypsin, complement C3, complement C4, immunoglobulin A, immunoglobulin G, immunoglobulin M, and transferrin. The Validate LP2 and SP1 kits are in a human serum matrix.
QFT-Plus added to Global Drug Facility catalog
January 2020—Qiagen’s QuantiFeron-TB Gold Plus has been added to the diagnostic catalog of the Stop TB Partnership’s Global Drug Facility. The GDF provides quality-assured tuberculosis medicines, diagnostics, and laboratory supplies to the public sector.
CytoSure constitutional NGS panel
January 2020—Oxford Gene Technology has developed the CytoSure NGS panel for the detection of loss of heterozygosity, mosaicism, copy number variants, single nucleotide variants, and indels. The solution features up-to-date content for intellectual disability and developmental delay, the targeted NGS panel, and Interpret software.
FDA approves Myriad MyChoice CDx
January 2020—The FDA has approved Myriad Genetics’ MyChoice CDx for use as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula (niraparib) in the late-line treatment setting. The FDA also approved the expanded use of Zejula (GlaxoSmithKline) for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency.
ChromaCode launches multidrug resistance assay
January 2020—ChromaCode has launched the HDPCR Multi-Drug Resistance (MDR) Panel, a highly multiplexed real-time PCR assay. The panel detects nine of the most common causes of Gram-negative multidrug resistance and toxigenic Clostridium difficile in a 96-well format. Key features of the panel, the company reports, include seamless integration onto common qPCR instrumentation, scalable throughput, and streamlined data analysis, management, and test customization with ChromaCode Cloud software. The MDR panel is for research use only.