Qiagen, Natera to develop genetic testing assays, 5/18
May 2018—Qiagen and Natera will partner to develop cell-free DNA assays, including for prenatal screening, for use on the Qiagen GeneReader NGS System.
Webinars and Sponsored Roundtables — Register Now
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
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 presenters Michelle Shiller, DO, AP, CP, MGP, FACP, Baylor University Medical Center.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
Subspecialties
Interactive Product Guides
Marketplace Directory
Technopath, Beckman Coulter partner, 5/18
May 2018—Technopath Clinical Diagnostics, an Ireland-based developer and manufacturer of total quality control solutions for clinical laboratories, and Beckman Coulter Diagnostics signed a long-term supply and distribution agreement.
Foundation Medicine CGP assay available in U.S., 5/18
May 2018—Foundation Medicine announced that FoundationOne CDx, an FDA-approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics, is available in the United States. FoundationOne CDx is a test for patients with advanced cancer and is offered as a nationally covered benefit across all solid tumors for Medicare and Medicare Advantage beneficiaries who meet eligibility requirements.
Helmer Scientific next-gen cell washer, 5/18
May 2018—Helmer Scientific 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.
FDA clears donor screening tests for B. microti infection, 5/18
May 2018—The FDA approved Oxford Immunotec’s Imugen Babesia microti arrayed fluorescent immunoassay for the detection of antibodies to Babesia microti in human plasma samples and the Imugen Babesia microti nucleic acid test for the detection of B. microti DNA in human whole blood samples.
New in vitro diagnostics company, 5/18
May 2018—Vidan Diagnostics, a San Antonio–based supplier of medical diagnostic products, announced it has officially started business operations in the United States. The company will soon launch its Lucidplus β-Ketone Plus Glucose Monitoring System, a point-of-care testing system to monitor patients with diabetic ketoacidosis. The company also plans to introduce tests for sepsis.
Analyte specific reagents, 5/18
May 2018—ElitechGroup Molecular Diagnostics introduced two high-performance, real-time PCR analyte specific reagents for JC virus and human herpes virus 8 detection.
FDA OKs Imfinzi for unresectable stage III NSCLC, 5/18
May 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.
Marketplace index by company
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FDA OKs Hydrashift 2/4 daratumumab, 4/18
April 2018—Sebia received FDA 510(k) clearance for its Hydrashift 2/4 daratumumab assay, intended to be used with Hydragel IF, for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis.