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.
Webinars and Sponsored Roundtables — Register Now
Tuesday, June 9, 2026, 1:00–2:00 PM ET
In this webinar, we will examine how immune recognition after allogeneic HCT can influence leukemia relapse and disease progression. The session will highlight the clinical relevance of HLA loss of heterozygosity (LOH), approaches used for its detection, and how LOH findings may support transplant strategies, including considerations for donor selection in subsequent transplantation.
Webinar presenter Alberto Cardoso Martins Lima, PhD, Clinical consulting scientist in histocompatibility,
specializing in allogeneic hematopoietic cell transplantation (HCT) at IGEN/AFIP São Paulo and CHC/UFPR in Curitiba, Brazil
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, June 24, 2026, 12:00–1:00 PM ET
Hear an expert discuss the expanded clinical utility of HER2 IHC scoring in metastatic breast cancer and its impact on your practice
Webinar presenter Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, July 15, 2026, 1:00-2:00 PM ET
Hear an expert discuss how to integrate Kappa and Lambda in situ hybridization testing into your standard hematopathology workflow to accurately assess B-cell and plasma cell clonality. You will also gain the skills to recognize testing pitfalls in challenging reactive versus neoplastic proliferations and apply ancillary tools to resolve complex cases.
Webinar presenter Xiaojun Wu, MD, PhD, Assistant professor, Director of Hematopathology Section at NCR of Johns Hopkins Medicine Department of Pathology, SOM at Johns Hopkins University
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Industry News
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
Thermo Fisher launches TrueMark infectious disease panels
Dec. 16, 2022—Thermo Fisher Scientific launched TrueMark Infectious Disease Research Panels.
FDA approves Qiagen CDx for NSCLC
Dec. 14, 2022—Qiagen announced FDA approval of its Therascreen KRAS RGQ PCR kit as a companion diagnostic test to aid in identifying non-small cell lung cancer patients eligible for treatment with adagrasib (Krazati, Mirati Therapeutics).
CompuGroup acquires Medicus Laboratory Information Systems
Dec. 9, 2022—CompuGroup Medical US announced the acquisition of Medicus Laboratory Information Systems from Diagnostic Systems Consulting LLC.