RT-PCR system available for COVID-19 testing
July 2020—Bio-Rad Laboratories announced that its CFX96 Dx Real-Time PCR System has been listed with the FDA for IVD testing and may be used to help in the diagnosis of COVID-19.
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
CAP TODAY
Randox QC for ToRCH test gets CE mark
July 2020—Randox Laboratories ToRCH quality controls for infectious disease testing in newborns have been granted the CE mark.
Siemens COVID-19 total antibody, molecular tests
June 2020—Siemens Healthineers announced it is shipping worldwide its CE-marked, laboratory-based total antibody test to detect the presence of SARS-CoV-2 IgM and IgG antibodies in blood. The test has demonstrated 100 percent sensitivity and 99.8 percent specificity and is available on the Atellica Solution immunoassay analyzer and the Advia Centaur XP and XPT analyzers. The test detects antibodies to a spike protein on the surface of the SARS-CoV-2 virus. “Studies indicate that certain (neutralizing) antibodies to the spike protein can disarm SARS-CoV-2, presumably by interfering with the ability of the virus to bind, penetrate, and infect human cells,” according to a press release from the company. “Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.”
FDA clears i-Stat CG4+, Chem8+
June 2020—Abbott’s i-Stat CG4+ and Chem8+ cartridges have received FDA clearance. The i-Stat CG4+ cartridge with the i-Stat 1 System is intended for use in the in vitro quantification of pH, PO2, PCO2, and lactate in arterial or venous whole blood in point-of-care or clinical laboratory settings. With the i-Stat CG4+, clinicians may assess the respiratory status of a patient or determine the presence of hyperlactatemia to inform the risk stratification of a patient diagnosed with sepsis.
ARUP offers second COVID-19 antibody test
June 2020—ARUP Laboratories announced that it is making a second COVID-19 IgG antibody test available nationwide.
Bio-Rad SARS-CoV-2 serology, ddPCR tests
June 2020—Bio-Rad Laboratories announced it was granted FDA emergency use authorization for the company’s SARS-CoV-2 Total Ab test. The test has also met the CE mark requirements for Europe.
Rheonix rapid molecular COVID-19 test receives EUA
June 2020—Rheonix announced it has received FDA emergency use authorization for the Rheonix COVID-19 MDx Assay. The fully automated test enables detection of SARS-CoV-2 directly from respiratory samples and runs on the Rheonix Encompass MDx workstation. The workstation is suitable for use in low- to medium-throughput labs and enables same-day results.
Nova Biomedical launches Stat EMS Basic
June 2020—Nova Biomedical launched its Stat EMS Basic blood testing system for ambulance and emergency care in countries that require the CE mark. Stat EMS Basic measures fingerstick capillary lactate, glucose, ketone, hemoglobin, and hematocrit in six to 40 seconds.
CE-marked Ortho COVID-19 total antibody test
June 2020—Ortho Clinical Diagnostics announced its COVID-19 total antibody test received the CE mark. The test offers excellent performance, with 100 percent specificity and sensitivity, and detects all COVID-19 related antibodies—IgA, IgM, and IgG.
Recombinant spike proteins for COVID dx testing
June 2020—Aalto Bio Reagents announced the availability of its range of recombinant SARS-CoV-2 spike (S) proteins for diagnostic test manufacturers, vaccine developers, and researchers.