FDA clears Abbott high sensitivity troponin-I test
December 2019—Abbott announced that its Architect Stat High Sensitivity Troponin-I blood test has received clearance from the FDA for use on the Architect analyzer.
Webinars and Sponsored Roundtables — Register Now
Wednesday, September 23, 2026. 12 PM-1 PM ET
Roundtable presenters Dr. David Sacks MB, ChB, FRCPath, Chairman, Steering Committee National Glycohemoglobin Standardization Program (NGSP), and Priya Sivaraman, PhD, Senior Technical Product Manager, Tosoh Bioscience.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Thursday, September 24, 2026 11 AM-12 PM CT
This session explores the evolving role of RAS in precision oncology, from the biology of RAS mutations to the expanding landscape of targeted therapies. Through expert presentations, real-world case discussions, and interactive audience polling, participants will examine best practices for RAS biomarker testing across solid tumors, including lung, colorectal, and pancreatic cancers. The session will highlight practical considerations for tissue and liquid biopsy, strategies to address testing gaps, and the importance of multidisciplinary collaboration to ensure timely identification of patients who may benefit from RAS-targeted therapies.
Webinar presenters David Braxton, MD, Chief of Molecular Pathology Services, Hoag Family Cancer Institute & Hoag Memorial Hospital Presbyterian, and Carlos Becerra, MD, Research Director for Medical Oncology, Margaret Given Larkin Endowed Chair for Developmental Cancer Therapeutics, Hoag Memorial Hospital Presbyterian.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Wednesday, September 30, 2026. 1 PM-1:30 PM ET
Roundtable presenters John Longshore, PhD, Head of Scientific Affairs, Global Oncology Diagnostics, AstraZeneca, and Flora Berisha, MS, Executive Director, Global Head of Diagnostic Partnering and Development, Johnson & Johnson Innovative Medicine, and Mark D. Ewalt, MD, Associate Medical Director for Laboratory Operations, Diagnostic Molecular Pathology, Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, and Isabel Preeshagul, DO, MBS, Thoracic Medical Oncologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Tuesday, October 20, 2026 11 AM-12 PM ET
Hear experts review the biological and clinical significance of the HER2 expression continuum in breast tissue, providing a clearer understanding of how these variations might impact diagnosis, and discuss the emerging importance of documenting HER2-low and HER2-ultralow categories using a validated IHC assay.
Webinar presenters Keith Wharton, MD, PhD, Global Medical Affairs Leader–Pathology,
Roche Diagnostics Solutions, and Hannah Y. Wen, MD, PhD, Director, Breast Pathology Fellowship, Associate Team Leader, Breast Pathology Team, Attending Pathologist, Memorial Sloan Kettering Cancer Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
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High-yield liquid biopsy sample prep platform
December 2019—nRichDX introduced its Revolution System, a high-yield sample prep platform designed to increase liquid biopsy–based test sensitivity by delivering more target input for molecular assays. The target yield increase is accomplished by combining the ability to process a range of sample volumes (3–50 mL) with recovery rates of 70–90 percent.
Prolaris test IDs who can choose active surveillance
December 2019—Myriad Genetics announced the publication of results from a clinical outcomes study that demonstrated the Prolaris genetic test can identify men with low-risk prostate cancer who can safely select active surveillance and defer treatment.
Capmatinib designated as breakthrough therapy
December 2019—The FDA granted breakthrough therapy designation to Novartis’ capmatinib (INC280) as a first-line treatment for patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer.
Ortho Clinical expands testing menu
December 2019—Ortho Clinical Diagnostics, in collaboration with Thermo Fisher Scientific, has expanded the menu on MicroTip-capable Vitros systems to enable testing for fentanyl and tricyclic antidepressants.
Beckman Coulter DxA 5000 gets 510(k) clearance
December 2019—Beckman Coulter announced that its DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is available for sale in the United States.
QIAstat-Dx Gl panel study results
December 2019—Qiagen announced the publication of a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis.
The study evaluated 385 patient samples at university hospital laboratories across Europe and showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2 percent positive) and specific (99.9 percent negative). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. The study also cited the ability of the panel to provide cycle threshold values and amplification curves to aid in interpreting results.
Roche launches Cobas EBV, BKV tests
December 2019—Roche announced the commercial availability of the Cobas EBV (Epstein-Barr virus) and Cobas BKV (BK virus) tests for use on the Cobas 6800/8800 systems in countries accepting the CE mark. The tests are used to assess if transplant patients are at risk of developing disease by these pathogens, which can contribute to organ rejection.
Keytruda combo gets accelerated approval
December 2019—The Food and Drug Administration granted accelerated approval to the combination of pembrolizumab (Keytruda, Merck) plus lenvatinib (Lenvima, Eisai) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation.
MilliporeSigma acquires FloDesign Sonics
December 2019—MilliporeSigma has acquired FloDesign Sonics, Wilbraham, Mass., developer of an acoustic cell processing platform for cell and gene therapy manufacturing.