Flocked-swab patent, 8/15
Puritan Medical Products announced that its flocked swab products do not infringe on the intellectual property of Copan, according to a decision recently issued by the European Patent Office.
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
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
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Glucose meter cleared for ICU, 8/15
The FDA has cleared Nova Biomedical’s StatStrip Xpress Glucose Hospital Meter System for use throughout all hospital and all professional health care settings, including among critically ill patients. StatStrip Glucose and StatStrip Xpress Glucose are, at press time, the only two hospital blood glucose meters to be cleared by the FDA for use with critically ill patients. StatStrip Xpress Glucose uses the same test strip measurement technology as StatStrip Glucose, which was cleared in 2014 after a four-year study conducted at five university medical centers.
Collaboration to develop cfDNA reference standards, 8/15
CareDx and Horizon Discovery Group will collaborate to develop cell-free DNA reference standards. The HDx Reference standards, being developed by Horizon Diagnostics, will support proficiency testing of CareDx’s solid organ transplant injury monitoring diagnostic tests and will be integrated into CLIA laboratory testing.
PerkinElmer, Covaris partnership, 8/15
PerkinElmer’s Chemagic research instrumentation and kits are now available with the Covaris TruXtrac FFPE DNA MicroTube Kit for Chemagen Technology for DNA/RNA purification powered by Adaptive Focused Acoustics technology. The kit rapidly removes paraffin and rehydrates formalin-fixed, paraffin-embedded tissues in an aqueous buffer. This preparation is optimized to work with PerkinElmer’s automated magnetic bead-based DNA/RNA separation technology for low-, medium-, and high-throughput solutions.
Chinese FDA premarket clearance, 8/15
Hangzhou Berry Genomics, a subsidiary of Berry Genomics, has received premarket clearance from the Chinese Food and Drug Administration for the NextSeq CN500, a high-throughput sequencing instrument developed with Illumina to meet Chinese clinical needs. Hangzhou Berry Genomics also received premarket clearance for its noninvasive prenatal testing detection kit for trisomies 13, 18, and 21.
Fully automated histology tissue embedding system, 8/15
Sakura Finetek USA will launch the Tissue-Tek AutoTEC a120 Automated Embedding System at the National Society of Histotechnology annual conference in Washington, DC, August 28–September 1, 2015.
Sample management software, 8/15
August 2015—Freezerworks released Freezerworks 2015, a major upgrade of its sample tracking and freezer inventory program. The upgrade offers advanced patient data management and security along with improvements in usability and integrates its two laboratory sample management programs, Basic and Unlimited, into a single platform.
510(k) clearance for diabetes testing assay, 8/15
August 2015—The FDA has cleared Ortho-Clinical Diagnostics’ Vitros Chemistry Products HbA1c Reagent Kit for use on the Vitros 5600 Integrated System, Vitros 4600 Chemistry System, and the Vitros 5,1 FS Chemistry System. The test can be used for the quantitative determination of percent glycated hemoglobin A1c and mmol/mol hemoglobin A1c in human whole blood.
Studies support role of BioTheranostics’ tests, 7/15
July 2015—BioTheranostics announced that clinical study data disclosed at the American Society of Clinical Oncology annual meeting in June demonstrate that its CancerType ID molecular cancer classifier and CancerTreatment NGS+ biomarker tests provide actionable genomic information to support an accurate diagnosis and treatment of metastatic cancers.
Targeted liquid biopsy mutation test, 7/15
July 2015—Biodesix launched GeneStrat, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer. Requiring only a blood draw, the test aims to offer a fast, minimally invasive alternative to a high-risk tissue biopsy or re-biopsy in patients with insufficient tissue.