In Vitro Diagnostics – IVD News

In the last 6 months, Teal Health and their clinical study partners exceeded their study enrollment numbers months ahead of schedule, produced strong clinical performance data, and was granted FDA Breakthrough status to help accelerate the review of their self-collect cervical cancer screening device. SAN FRANCISCO, May 8, 2024 /PRNewswire/ — Teal Health, a woman-led company on…

ROCKVILLE, Md., April 18, 2023 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced that it has submitted a De Novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for its Unyvero UTI Urinary Tract Infection (UTI)…

ROCKVILLE, Md., Dec. 13, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced top line data from its successfully completed Unyvero UTI clinical trial. OpGen’s Unyvero UTI Panel tests for a broad range of bacterial and fungal pathogens as…

InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, has completed the validation of metabolic biomarker panels for the early detection of hypoxic ischemic encephalopathy (HIE) in newborns.  The validated biomarkers of such panels will be the target of the company’s HypoxE blood test for…

ROCKVILLE, Md. and BASEL, Switzerland, Oct. 25, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, and BioVersys AG, a privately-held clinical stage, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in…

Cologne/Berlin, Germany, and Boston, MA, USA, October 12, 2022 – InfanDx AG, a privately held diagnostics company focusing on the development and commercialization of novel diagnostic solutions for newborns, today announced that it successfully completed the validation of metabolic biomarker panels for the early detection of Hypoxic Ischemic Encephalopathy (HIE) in newborns. The validated biomarkers of such…

ROCKVILLE, Md., Oct. 03, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced its successful completion of patient enrollment for its clinical trial for the Unyvero Urinary Tract Infection (UTI) Panel. OpGen’s Unyvero UTI Panel tests for a broad range…

Innovation competition between early cancer detection test developers is in the spotlight due to the European Commission blocking Illumina’s bid to buy Grail. More than 20 companies in Europe developing liquid biopsy tests may benefit from the recent European Commission decision to prohibit Illumina’s acquisition of Grail in the EU. The GlobalData MIC Pipeline Products…

ROCKVILLE, Md., Sept. 20, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced the signing of an R&D collaboration agreement with FIND, the global alliance for diagnostics, for the Unyvero A30 RQ platform for use in rapid pathogen ID and…

ROCKVILLE, Md., Aug. 25, 2022 (GLOBE NEWSWIRE) — OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and informatics to help combat infectious disease, announced today that it has launched next generation sequencing (NGS) services in the U.S. that were developed by its subsidiary, Ares Genetics (“Ares”), which strives to become a…