FDA expands approval of BD Onclarity HPV assay
Feb. 21, 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test.
Webinars and Sponsored Roundtables — Register Now
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
Thursday, May 28, 2026, 1:00–2:00 PM ET
This session is designed to improve understanding and application of recent updates to synoptic pathology reporting protocols such as the latest Reporting Template for Reporting Results of Biomarker Testing of Specimens from Patients with Carcinoma of the Breast. These changes reflect evolving clinical guidelines that directly influence diagnostic accuracy and treatment selection in breast cancer care.
Webinar presenters Thaer Khoury, MD, FCAP, Chair, Pathology and Laboratory Medicine, Roswell Park Comprehensive Cancer Cente, and Colin Murphy, CEO of mTuitive.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Industry News
SeraCare releases HRD reference materials
Feb. 16, 2023—LGC SeraCare has developed three contrived, tumor-normal cell-line–derived homologous recombinant deficiency reference materials, Seraseq FFPE HRD High-Positive RM, Seraseq FFPE HRD Low-Positive RM, and Seraseq FFPE HRD Negative RM.
AscencioDx COVID-19 test, molecular detector get EUA
Feb. 14, 2023—Anavasi Diagnostics announced FDA emergency use authorization for its AscencioDx COVID-19 test and AscencioDx molecular detector for use in point-of-care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.
BioFire SpotFire system and panel get 510(k) clearance
Feb. 8, 2023—BioMérieux has received FDA 510(k) clearance and a CLIA waiver for its BioFire SpotFire system and respiratory panel.
Stemline’s Orserdu approved for patients with ESR1 mutations
Jan. 31, 2023—The U.S. Food and Drug Administration has approved Stemline Therapeutics’ Orserdu (elacestrant) for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Congress nixes national patient identifier—again
Jan. 30, 2023—Congress once more failed to embrace movement towards a national patient identification system, leaving in place a ban on using federal funds to promote or adopt NPI standards in the omnibus fiscal year 2023 spending bill.
Qiagen launches EZ2 Connect MDx for diagnostic use
Jan. 19, 2023—Qiagen has launched its EZ2 Connect MDx for use in diagnostic laboratories.
Agilent, Akoya Biosciences to develop multiplex IHC solutions
Jan. 17, 2023—Agilent Technologies announced a partnership with Akoya Biosciences to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics.
Qiagen, Helix partner to advance CDx for hereditary diseases
Jan. 6, 2023—Qiagen announced an exclusive strategic partnership with Helix to advance companion diagnostics for hereditary diseases.
FDA approves FoundationOne Liquid CDx for a group of TKIs
Dec. 28, 2022—The FDA has approved Foundation Medicine’s FoundationOne Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of tyrosine kinase inhibitors approved by the FDA for this indication