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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FDA authorizes POC antibody test for COVID-19

January 2021—The FDA issued an emergency use authorization for the first serology antibody point-of-care test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device (Azure Biotech) was first authorized in July for emergency use by certain labs to help identify individuals with antibodies to SARS-CoV-2. The EUA has been reissued to authorize the test for POC use using fingerstick blood samples. The lateral flow assay is authorized for use with venous whole blood, serum, plasma, and fingerstick whole blood.

Roche CE-marked Cobas PIK3CA Mutation Test

January 2021—Roche launched the Cobas PIK3CA Mutation Test CE-IVD for patients with advanced or metastatic breast cancer in countries accepting the CE mark. The test was previously available for research use only.

510(k)-cleared, CLIA-waived Accula Strep A test

January 2021—Mesa Biotech received 510(k) clearance and CLIA waiver from the FDA for its Accula Strep A test. The strep A cassette, for the molecular detection of group A Streptococcus bacterial nucleic acid, is cleared for diagnosing children and adults and provides results in 30 minutes at the point of care.

Verichem Labs reference materials

December 2020—Protein-based, ready-to-use liquid Matrix Plus Cholesterol Reference kits are available from Verichem Laboratories. The kits are designed to support overall system quality control and CLIA compliance and are for the calibration or calibration verification of cholesterol and uric acid wet assays on clinical testing systems. The materials contain esterified and free cholesterol from bovine serum. The standard kit with the sixth level F covers 12 concentration points; cholesterol concentrations range from 40 to 750 mg/dL and uric acid concentrations from 2 to 30 mg/dL. Active components are verified using standard reference materials from the National Institute of Standards and Technology. Shelf life is 21 months from the date of manufacture. Ready-to-use, liquid Total Protein and Albumin reference materials are also available. The combined Total Protein/Albumin Standard kit, along with the optional standalone Total Protein/Albumin Standard level F, are designed for the calibration and calibration verification of albumin and total protein assays on a wide number of clinical testing systems. The standards are prepared with human serum albumin and gamma-globulin serum proteins in a saline-based solution. Shelf life is 24 months from the manufacturing date.

FDA approves Gavreto for metastatic RET fusion-positive NSCLC

December 2020—Roche announced FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection fusion–positive non-small cell lung cancer as detected by an FDA-approved test. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.

FDA approves first treatment for COVID-19

December 2020—The FDA approved Gilead Sciences’ antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should be administered only in a hospital or health care setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

COVID-19, flu, RSV test available from ARUP

December 2020—ARUP Laboratories announced the availability of a combined test to detect and differentiate COVID-19, influenza, and/or respiratory syncytial virus in individuals with respiratory symptoms consistent with COVID-19. The test can be performed on specimens collected using a deep nasal swab or on specimens collected from the back of the throat and the front of both nostrils.

Siemens, Novartis to develop assays

December 2020—Siemens Healthineers announced a master collaboration agreement with Novartis Pharma to design, develop, and commercialize diagnostic tests for therapeutic products across Novartis’ therapeutic pipeline. The initial program will focus on developing a serum neurofilament light chain immunoassay for patients with multiple sclerosis and other neurological diseases.