FDA clears Cepheid Xpert GI multiplex PCR test
March 2026—Cepheid received FDA clearance for its Xpert GI panel, a multiplex PCR test designed to detect gastrointestinal pathogens from a single patient sample.
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
Subspecialties
Interactive Product Guides
Cepheid
FDA clears Cepheid Xpert GI multiplex PCR test
Feb. 17, 2026—Cepheid received FDA clearance for its Xpert GI panel, a multiplex PCR test designed to detect gastrointestinal pathogens from a single patient sample.
Cepheid gets Health Canada license for Xpert HIV-1 Viral Load XC
September 2025—Cepheid has received a medical device license from Health Canada for its Xpert HIV-1 Viral Load XC, a next-generation extended-coverage test intended to aid in assessing HIV viral load levels. The test is designed for use on the company’s GeneXpert systems.
Newsbytes
May 2025—Duke University has launched its Duke Center for Computational and Digital Health Innovation, which is intended to drive technological advances in the areas of wearable sensors, high-performance computing, and extended reality solutions. “Our center provides a vibrant platform for innovation and collaboration, where researchers, clinicians, engineers, and industry partners work side-by-side to pioneer new solutions,” says an open letter from Amanda Randles, PhD, director of the center. Faculty support for the center comes from the Duke University School of Medicine, School of Nursing, Trinity College of Arts and Sciences, and Pratt School of Engineering.
Cepheid Xpert HCV gets FDA authorization, waiver
September 2024—Cepheid has received FDA de novo marketing authorization and CLIA waiver approval for its Xpert HCV, the first point-of-care hepatitis C RNA test. The test can accurately detect active HCV infection from individuals at risk and/or with signs and symptoms of HCV infection with or without antibodies to HCV from a capillary blood sample.
Cepheid Xpert HCV gets FDA authorization, waiver
July 2, 2024—Cepheid has received FDA de novo marketing authorization and CLIA waiver approval for its Xpert HCV, the first point-of-care hepatitis C RNA test.
Cepheid gets CLIA waiver for Xpert Xpress MVP
March 2024—Cepheid announced it has received FDA clearance with a CLIA waiver for the Xpert Xpress MVP, a multiplex vaginal panel that can now be performed in near-patient settings. The test is intended to aid in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis from a single specimen. It runs on Cepheid’s GeneXpert Xpress instruments and provides results within an hour.
Cepheid SARS-CoV-2, flu, RSV test gets EUA
November 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses that cause COVID-19, flu A, flu B, and RSV infections from a single patient sample.
Cepheid SARS-CoV-2, flu A/B, RSV test gets EUA
Oct. 5, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2/Flu/RSV, a rapid molecular diagnostic test for qualitative detection of the viruses that cause COVID-19, flu A, flu B, and RSV infections from a single patient sample.
Cepheid receives EUA for its SARS-CoV-2 test
March 23, 2020—Cepheid received emergency use authorization from the FDA for its Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2. The test is for use on the automated GeneXpert systems, with a detection time of about 45 minutes.