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New Idylla Ebola Virus Triage Test Granted Emergency Use Authorization by U.S. FDA

As part of Johnson & Johnson’s commitment to combat Ebola, Janssen Pharmaceutica NV today announced that the Idylla™ Ebola Virus Triage Test (Idylla™ EBOV Test) was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA)[1]. The Idylla™ Ebola Virus Triage Test is a diagnostic that detects the presence of the Ebola Zaire virus in patients with signs and symptoms of Ebola virus disease and was jointly developed by Janssen Diagnostics, a division of Janssen Pharmaceutica, Biocartis NV (Biocartis), and the Belgium Institute of Tropical Medicine.

Roche Announces the First FDA-approved CMV Test for Use in Hematopoietic Stem Cell Transplant Recipients

Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced the United States Food and Drug Administration (FDA) approval of the first cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients. With this approval, the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is available for monitoring CMV treatment in all types of transplant patients in the USA. The test was the first in vitro diagnostic test conforming to the WHO International Standard, making it possible for laboratories worldwide to obtain comparable results when testing for CMV and it is now the most commonly used in vitro diagnostic test for CMV solid organ transplant recipients in the USA.

ACLA Retains Attorneys Paul D. Clement and Laurence H. Tribe To Represent ACLA in Opposing the FDA’s Proposal To Treat Laboratory Developed Tests (LDTs) as Medical Devices

The American Clinical Laboratory Association (ACLA) announced today that it has retained former Solicitor General Paul D. Clement, a partner with Bancroft PLLC, and Laurence H. Tribe, the Carl. M. Loeb University Professor and Professor of Constitutional Law at Harvard University, and a distinguished scholar working with Massey & Gail LLP, for representation on matters relating to the Food and Drug Administration’s (FDA) recently issued draft guidance to regulate laboratory developed tests (LDTs) as medical devices.

Corgenix Announces Filing of 510(k) Premarket Notification for FDA Clearance of TxBCardio Assay

Corgenix Medical Corporation (OTC BB: CONX.OB) recently announced that in collaboration with Randox Laboratories, the first premarket notification has been filed with the U.S. Food and Drug Administration pursuant to Section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act for the TxBCardio™ immunoturbidimetric (IT) assay.

FLUIDDA Presents Novel Imaging Technology for Respiratory Diseases to FDA

Functional Respiratory Imaging (FRI) is FLUIDDA’s proprietary imaging technology with the unique capability of producing highly clinical relevant patient specific biomarkers. These biomarkers present 3D visualization of the patient’s airway and lung geometry, airway resistance and aerosol deposition patterns.