FDA-cleared POC tests for BUN, TC02, 4/18
April 2018—Siemens Healthineers received FDA 510(k) clearance for its blood urea nitrogen and total carbon dioxide point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances.
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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Validate verification kits, 4/18
April 2018—LGC Maine Standards released two Validate linearity and calibration verification kits. The Validate Procalcitonin kit for Roche Cobas analyzers is in a human-serum matrix. The Validate HbA1c kit is for Tosoh analyzers and is in a human, whole blood matrix.
Thermo Fisher expands Oncomine portfolio, 4/18
April 2018—Thermo Fisher Scientific has expanded its Oncomine portfolio with two assays for liquid biopsy and immuno-oncology for clinical research. The company also announced its next-generation Ion AmpliSeq HD technology. The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay enables reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations (SNVs, indels, CNVs, and fusions) from a single vial of blood, with as little as 1 ng of nucleic acid input, within two days.
CE-marked Cobas Plasma Separation Card, 4/18
April 2018—Roche launched the Cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. By requiring only a small amount of a patient’s blood from a fingertip, this card simplifies blood collection and sample transportation, as compared with traditional plasma-based testing.
Beckman Coulter adds 6-AM and BUP assays, 4/18
April 2018—Beckman Coulter Diagnostics announced the addition of 6-acetylmorphine and buprenorphine assays to its menu of drugs-of-abuse tests for use on its AU chemistry analyzers (AU480, AU680, AU5800). The Syva Emit II Plus 6-AM assay provides a convenient and quick way to selectively screen for heroin use, in place of methods such as gas chromatography and mass spectrometry.
FDA clears QuickVue Influenza A+B test, 4/18
April 2018—Quidel announced it has received FDA 510(k) clearance for its CLIA-waived QuickVue Influenza A+B assay.
Celgene acquires Juno Therapeutics, 4/18
April 2018—GlobalData says Celgene’s acquisition of Juno Therapeutics in January, for $9 billion, has put the company in a “good position to be a frontrunner in the chimeric antigen receptor-T cell space.” Celgene stands to benefit from Juno’s expertise and ongoing work in addressing concerns surrounding CAR-T, according to a release from GlobalData, a market research consulting company.
Recombinant antigens, monoclonal antibodies, 4/18
April 2018—Binding Site’s Immunologicals Group has added three recombinant Treponema pallidum antigens to its in vitro diagnostic product line: T. pallidum TpN-15, TpN-17, and TpN-47. The antigens are derived and sourced from E. coli via culture and then purified to a level of >95 percent and confirmed via sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE).
FDA-cleared test to detect Campylobacter, 4/18
April 2018—Techlab has received FDA clearance for the Campylobacter Quik Chek and the Campylobacter Chek tests to aid the diagnosis of campylobacteriosis. The Campylobacter Quik Chek test is a rapid diagnostic test that detects Campylobacter jejuni and Campylobacter coli in less than 30 minutes.
Roche, GE to develop digital diagnostics platform, 4/18
April 2018—Roche and GE Healthcare will partner to develop and co-market digital clinical decision support solutions. The companies aim to develop a digital platform using analytics to provide workflow solutions and apps that support clinical decisions. This will allow the integration and analysis of in vivo and in vitro data, patient records, medical best practices, real-time monitoring, and the latest research outcomes.