Verichem Labs reference materials
July 2021—Verichem Laboratories announced the availability of ready-to-use, liquid-stable clinical reference materials for the calibration and calibration verification of clinical testing systems.
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
NeuMoDx COVID-19 multiplex test gets EUA
July 2021—Qiagen announced FDA emergency use authorization for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, to help identify and differentiate people suspected of respiratory viral infection consistent with COVID-19.
SML Genetree Ezplex SARS-CoV-2 G Kit gets EUA
July 2021—The SML Genetree Sciences’ Ezplex SARS-CoV-2 G Kit has been granted FDA emergency use authorization. This is a real-time PCR in vitro diagnostic test for the qualitative detection of nucleic acid for SARS-CoV-2 RdRp and N genes from nasopharyngeal and oropharyngeal swabs and sputum specimens. The test can also be used for up to five pooled individual nasopharyngeal or oropharyngeal swabs. Testing of the FDA SARS-COV-2 Reference Panel showed a detection limit of 1,200 NAAT detectable units (NDU)/mL.
Thermo Fisher launches TaqPath COVID-19 2.0 test
July 2021—Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0. The kit uses an advanced assay design that compensates for current and emerging variants, the company says, by using eight targets across three genomic regions of the virus to help ensure the test provides accurate results even as the virus mutates.
Roche adds high-throughput configurations to Cobas Pro
July 2021—Roche launched eight configurations for its Cobas Pro integrated solutions, in countries accepting the CE mark. As a result, the analyzer can deliver up to 4,400 tests per hour, doubling its previous testing capacity. It is now possible to add two analytical units of Cobas c 503 and/or Cobas e 801, consolidating up to four analytical units on one platform.
Beckman launches quantitative COVID-19 IgG test
July 2021—Beckman Coulter launched its Access SARS-CoV-2 IgG (1st IS), a fully quantitative lab-based immunoglobulin G serology test that measures the quantity of antibodies against the virus that causes COVID-19. The assay is traceable to the First WHO International Standard for anti-SARS-CoV-2, 20/136, and reports results aligned with BAU/mL established by the World Health Organization.
DiaSorin releases Simplexa SARS-CoV-2 Variants Direct assay
July 2021—DiaSorin Molecular has released the Simplexa SARS-CoV-2 Variants Direct assay, for research use only, to enable detection and discrimination of four SARS-CoV-2 mutations associated with circulating virus variants without requiring upfront RNA extraction. The assay allows for the in vitro qualitative differential detection of the mutations N501Y, E484K, E484Q, and L452R from nasopharyngeal and nasal swab specimens from individuals previously diagnosed with COVID-19. These mutations are present in potential variants of clinical interest including those that were isolated in the U.K. (B.1.1.7), South Africa (B.1.351), Brazil and Japan (P.1 and P.2), New York (B.1.526/B.1.526.1), California (B.1.427/B.1.429), Nigeria (B.1.525), and India (B.1.617/B.1.617.1/ B.1.617.2/B.1.617.3).
Labcorp, OmniSeq launch NGS genomic profiling device
July 2021—Labcorp and OmniSeq announced the launch of OmniSeq Insight, a pan-cancer, solid tumor test that combines genomic and immune profiling, including tumor mutational burden, microsatellite instability, and immune gene expression, and integrates next-generation sequencing technology.
Qiagen, DiaSorin launch Liaison LymeDetect
July 2021—Qiagen and DiaSorin launched the Liaison LymeDetect assay for markets accepting the CE mark, as an aid to detect early Lyme borreliosis infection on the DiaSorin Liaison XL and Liaison XS platforms.
Sysmex adds XN-10 blood bank mode to portfolio
July 2021—Sysmex America has added the FDA-cleared XN-10 Automated Hematology Analyzer with Blood Bank mode to its portfolio of hematology solutions. The analyzer supports red blood cell and platelet component testing and provides an automated complete blood count with differential for whole blood samples. The XN blood bank mode is intended for use in blood processing centers for QC release testing of post-processed components.