FDA OKs screening tests for tick-borne parasite
March 19, 2018—The FDA approved Oxford Immunotec’s Imugen Babesia microti arrayed fluorescent immunoassay for the detection of …
Webinars and Sponsored Roundtables — Register Now
Tuesday, April 28, 2026, 12:00 PM–1:00 PM ET
Discover how next-day comprehensive genomic profiling (CGP) is possible with the Oncomine Comprehensive Assay Plus on the Genexus System—delivering both speed and accuracy.
Webinar presenters Jane Bayani, MHSc, PhD, Assistant Professor and Co-Director, Diagnostic Development, Ontario Institute for Cancer Research, Canada, and Nicola Normanno, MD, Scientific Director, IRCCS Romagnolo Institute for the Study of Tumors, Italy, and Morten Grauslund, PhD, Molecular Biologist, Department of Pathology, Rigshospitalet/Copenhagen University Hospital, Copenhagen, Denmark.
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 Thermo Fisher Scientific. For Research Use Only. Not for use in diagnostic applications.
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
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FDA clears first DTC genetic test on cancer risk
March 16, 2018—23andMe received the first FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows 23andMe to provide customers, without a prescription, information on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population. The test analyzes DNA collected from a self-collected saliva sample, and the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report describes
FDA clears POC Sofia Lyme FIA for Sofia 2
March 15, 2018—Quidel received 510(k) clearance from the FDA to market its Sofia Lyme FIA to be used with the Sofia 2 fluorescent immunoassay analyzer for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of B. burgdorferi infection, which causes Lyme disease. “The Sofia Lyme Assay’s 510(k) clearance for use on the Sofia 2 instrument will allow health care workers to generate a faster result, thereby accelerating
Randox teams up with Bosch
March 14, 2018—Randox Laboratories and Bosch Healthcare Solutions will unveil Vivalytic, a fully automated molecular diagnostics platform, at the 28th European Congress of Clinical Microbiology and Infectious Diseases, April 21–24, in Madrid. Vivalytic supports end-point PCR, quantitative real-time PCR, melting curve analysis, and microarray technology, enabling singleplex, low-plex, and high multiplex testing on the same device. Depending on the test application, results are available in 30 minutes. “This is transformational for patients and doctors; never before has there been this
FDA OKs Imfinzi for unresectable stage III NSCLC
March 13, 2018—AstraZeneca and MedImmune, its biologics research and development arm, announced the FDA has approved Imfinzi (durvalumab) for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. “This is the first treatment approved for stage III unresectable non-small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” Richard Pazdur, MD, director of the FDA’s
Diaceutics teams up with Lenovo and Intel
March 9, 2018—Diaceutics, based in Dundalk, Ireland, will collaborate with tech companies Lenovo and Intel to leverage their vast proprietary database of patient testing data. Diaceutics will use artificial intelligence to see whether patients can be grouped according to diagnostic test information in hopes the data can help identify ways to improve diagnosis, treatment, and outcomes for patients with similar characteristics. The company will use Lenovo’s ThinkStation P920, powered by Intel Xeon scalable processors, and testing data from hundreds of
BD HPV assay gets premarket approval
March 8, 2018—Becton Dickinson received premarket approval from the FDA for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers and are responsible for up to 94 percent of glandular cervical cancer cases. In evaluating the test, the FDA reviewed data
CAP TODAY webinar on molecular testing in AML
March 6, 2018—CAP TODAY is hosting a webinar titled “Molecular Testing in AML: From Today to Tomorrow” on Wednesday, March 7, 1 PM ET. This hourlong webinar is presented by Pritish K. Bhattacharyya, MD, and moderated by CAP TODAY publisher Bob McGonnagle. The webinar will allow you to understand the complexities of acute myeloid leukemia, learn the common mutations tested for in AML, review mutational testing in the 2017 CAP/American Society of Hematology guideline, and discuss the timeliness of testing
Helmer Scientific launches next-gen cell washer
March 2, 2018—Helmer Scientific has announced the release of its FDA 510(k)-cleared, next-generation automatic cell washing system, the UltraCW II, for hospital blood banks and clinical laboratories. The UltraCW II automates steps within typical tube testing blood bank workflows. It removes plasma and unwanted antibodies from blood cells for pretransfusion testing procedures—ABO and Rh grouping, antibody identification, and cross-matching. The system features a color touchscreen for intuitive and easy-to-use programming and operation. An electronic flow meter and digital calibration ensure
CDC to use IGRAs for immigration TB screening
Feb. 28, 2018—The U.S. Centers for Disease Control and Prevention issued a notification to U.S. civil surgeons stating it will require the use of FDA-approved interferon gamma release assays for tuberculosis screening. The CDC plans for the change to go into effect Oct. 1. The use of the tuberculin skin test will no longer be allowed for use in immigration screening, including for children under age five. Qiagen said in a statement that it welcomes the decision by the CDC to use