TTF1, napsin A tests for lung cancer diagnostics
February 2021—Novodiax launched two rapid IhcDirect antibody assays, TTF1 and napsin A, for in vitro diagnostic use.
Webinars and Sponsored Roundtables — Register Now
Thursday, April 30, 2026, 11:00 AM–12:00 PM ET
Hear an expert discuss how Memorial Sloan Kettering Cancer Center (MSKCC) is utilizing
the oncoReveal® Nexus 21-gene panel to redefine turnaround time and actionable insights
in cancer care. Dr. Ewalt shares a perceptive look at the clinical need for rapid, front-line NGS sequencing, and how a unique, purpose built targeted NGS panel (Pillar Biosciences’ oncoReveal Nexus 21 gene Panel) was developed, validated and implemented clinically by Memorial Sloan Kettering Cancer Center (MSK-REACT) to complement their current comprehensive genomic profiling (CGP) approach.
Webinar presenter Mark Ewalt, MD, Associate Medical Director for Laboratory Operations for Diagnostic Molecular Pathology in the Molecular Diagnostics Service, Department of Pathology and Laboratory Medicine, MSKCC.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Pillar Biosciences.
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
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FDA authorizes OTC at-home test for COVID-19
January 2021—The FDA issued an emergency use authorization for the first over-the-counter, at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test that detects fragments of proteins of the SARS-CoV-2 virus using a mid-turbinate nasal swab sample from any person two years of age or older. The Ellume home test correctly identified 96 percent of positive samples and 100 percent of negative samples in people who had symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples. The home test uses an analyzer that connects with a software application on a smartphone to help users perform the test and interpret results. Results are delivered in as little as 20 minutes via a person’s smartphone. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” FDA commissioner Stephen M. Hahn, MD, said in a statement released by the agency. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
Nova Biomedical blood glucose reference analyzer
January 2021—Nova Biomedical announced the availability of Nova Primary, a rapid blood glucose laboratory analyzer. Nova Primary fills the need for a glucose reference analyzer to replace the YSI Stat Plus 2300 Glucose and L-Lactate analyzer, which, as of July 2021, will no longer be supported by YSI, Inc.
Qiagen fully acquires NeuMoDx Molecular
January 2021—Qiagen has acquired the remaining 80.1 percent of NeuMoDx Molecular for $248 million in cash. The company purchased a 19.9 percent stake in NeuMoDx in 2018, along with the right to acquire the remaining stake. As part of the 2018 deal, Qiagen has distributed the NeuMoDx 288 and NeuMoDx 96 platforms in Europe and other markets outside the United States.
GenMark ePlex RP2 panel receives EUA
January 2021—GenMark Diagnostics received FDA emergency use authorization for its ePlex Respiratory Pathogen Panel 2. The test provides results in less than two hours for more than 20 viruses and bacteria that cause respiratory infections, including COVID-19, flu, bronchitis, and the common cold.
Verichem Labs offers data reduction services
January 2021—Verichem Laboratories is offering its customers free access to the company’s online, web-based data reduction services. Designed for use with Verichem’s products, the service supports the necessary statistics required within the clinical laboratory to satisfy current CLIA and CAP requirements for the calibration verification of clinical assays.
Randox multiplex controls for respiratory disease
January 2021—Randox Laboratories has unveiled its Qnostics Multiplex Respiratory Pathogen Controls for respiratory diseases, including for SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The RTX controls are used to monitor the full testing process, from extraction to amplification and detection, and are compatible with a majority of commercial and in-house assays.
Siemens test measures neutralizing antibodies
January 2020—Siemens Healthineers’ SARS-CoV-2 IgG Antibody Test has proven to measure neutralizing antibodies, the company announced. The test reports quantitative results measuring the amount of neutralizing antibodies present in a patient’s blood sample.
BD FacsLyric 510(k) cleared with FacsDuet sample prep system
January 2021—BD received FDA 510(k) clearance for the BD FacsLyric flow cytometer integrated with the BD FacsDuet sample preparation system. Physical integration between the two instruments allows technicians to load samples and reagents onto the BD FacsDuet and obtain results once the samples are acquired and analyzed on the BD FacsLyric. Data integration using the BD FacsLink middleware solution offers bidirectional communication between the instruments and connectivity with laboratory information systems.
Streck launches rapid, modular qPCR instrument
January 2021—Streck has launched its Zulu RT, a rapid, modular qPCR instrument. The instrument consists of four independent thermal modules. A user can operate any combination of modules—one module for a small sample set, leaving other modules for other users, or up to four modules simultaneously for a large sample set. It can perform a 40-cycle, six-channel real-time PCR in less than 20 minutes.