NeoGenomics, Definiens to develop novel assays, 6/17
June 2017—NeoGenomics and Definiens have expanded their alliance to develop and automate the analysis of new biomarker assays for clinical trials and routine clinical testing.
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
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IHC imaging and analysis system, 6/17
June 2017—Applied Spectral Imaging introduced its HiPath imaging and analysis system, which provides computer-assisted PD-L1 interpretation for research use.
CLSI phlebotomy documents, 6/17
June 2017—The Clinical and Laboratory Standards Institute has published two new phlebotomy documents, “Collection of Diagnostic Venous Blood Specimens (GP41-Ed7)” and “Essential Elements of a Phlebotomy Training Program (GP48-Ed1).”
Circulating cell-free DNA isolation kit, 6/17
June 2017—MagBio Genomics launched its cfKapture 21 kit, a circulating cell-free DNA isolation kit that includes a proprietary reagent designed to prevent post-separation degradation of plasma and ccfDNA fragments for up to 21 days at room temperature. This feature allows laboratories to safely transport and process samples in a longer time frame without the need for extensive cold chain.
FDA clearance for Alere Reader platform, 6/17
June 2017—Alere announced that its Alere Reader, a diagnostic platform with objective result interpretation and connectivity capabilities that can be used to evaluate a variety of lateral flow immunoassay formats and that can be used in point-of-care and laboratory settings, received FDA 510(k) clearance.
ArcherDx, HeliTec strategic partnership, 6/17
June 2017—ArcherDx and precision medicine company HeliTec (Shenzhen, China) announced a strategic partnership to advance NGS-based cancer diagnostic development in China. The partnership will entail co-developing and cross-licensing NGS-based technologies with the goal of registering oncology diagnostic kits with the Chinese Food and Drug Administration.
Drugs of abuse screening reagents, 6/17
June 2017—MedTest announced the commercial launch of urine drugs of abuse screening reagents on the Mindray BA-800M chemistry analyzer for use in clinical laboratories in the United States.
Hematology analyzers, 6/17
June 2017—Horiba has developed two new hematology systems, the Yumizen H1500 and the Yumizen H2500. The CE-marked analyzers offer a throughput of 120 tests per hour for complete blood count, including differential and nucleated red blood cells, and are equipped with a three-dimensional count capable of combining the measurements of cellular complexity, volume, and distribution for each of the leukocyte subpopulations.
FDA-approved sepsis test, 6/16
June 2017—Immunexpress received FDA 510(k) clearance for the use of SeptiCyte Lab as an aid in differentiating infection-positive (sepsis) from infection-negative (SIRS) systemic inflammation in critically ill patients on their first day of ICU admission. It is the first RNA-based clinical diagnostic tool, direct from whole blood, to aid medical providers in the early identification of infection in suspected sepsis patients, according to a company statement.
Siemens gets $8.9 million to develop Zika test, 6/17
June 2017—The U.S. Department of Health and Human Services announced that Siemens Healthineers has been awarded $8.9 million by the Office of the Assistant Secretary for Preparedness and Response’s Biomedical Advanced Research and Development Authority to advance the development of a Zika assay for use on the company’s Advia Centaur XPT, Advia Centaur XP, and Advia Centaur CP immunoassay systems for the clinical laboratory.