GenMark Diagnostics has received 510(k) clearance from the US Food and Drug Administration (FDA) for its eSensor Respiratory Virus Panel(RVP) for use on its XT-8 system. The eSensorRVP test simultaneously detects and differentiates 14 ...
Tags: XT-8 system, FDA, clinical technology, clinical research
The FDA has granted approval for Great Basin's first molecular diagnostic test for Clostridium difficile (C. diff). The integrated cartridge system comprises necessary reagents to perform the assay and predict the presence of ...
Tags: molecular diagnostic test, clinical product, clinical research
Akrimax Pharmaceuticals has introduced Suprenza (phentermine HCl) orally disintegrating tablets (ODT) for the management of exogenous obesity. The company has launched Suprenza ODT in 15mg and 30mg dosage strengths. Suprenza is ...
Tags: pharceumatical product, obesity drugs, clinical research
Medica has unveiled EasyCell assistant cell image analyzer, designed for automating and simplifying cell differential process by locating and preclassifying white blood cells. The launch was based on the completion of clinical ...
Tags: clinical research, clinical technology, cell image analyzer
MDxHealth and PLUS Diagnostics have reached an agreement to co-promote MDxHealth's ConfirmMDx for prostate cancer in the US. ConfirmMDx is a laboratory-developed test (LDT), which assists urologists with identifying men who may safely ...
Tags: prostate cancer assay, cancer assessment, clinical research
CeeTox and Cellular Dynamics International (CDI) have introduced a new predictive cardiac safety screening service, Cardiac Arrhythmia Assessment Screen (CAAS), which uses human induced pluripotent stem (iPS) cell-derived cardiomyocytes. ...
HTG Molecular Diagnostics has collaborated with John Wayne Cancer Institute (JWCI) to market its HTG melanoma signature assays. The signature assays may be useful for diagnostic and prognostic applications along the melanoma ...
Tags: HTG melanoma signature assays, clinical technology, clinical research
Meridian Bioscience has received FDA clearance for TRU Legionella, a new rapid assay for detection of legionellosis. TRU Legionella provides optimized detection of Legionella pneumophila serogroup 1 that is most commonly associated ...
Tags: TRU Legionella, detection of legionellosis, clinical research
Nextrials has partnered with InClin to deliver next generation clinical research services. As part of the partnership, researchers are expected to have the advantage of linking Nextrials' Prism, a clinical trial data management ...
Tags: clinical research services, company cooperation, clinical plaform
PDS Biotechnology has entered into a licensing agreement with Merck KgaA, Germany, for use of PDS Biotechnology's Versamune nanotechnology platform. Under the terms of the agreement, Merck will obtain the rights to use the technology ...
Tags: Versamune nanotechnology platform, company cooperation
INC Research, a clinical research organization, has selected Trial Interactive as its global electronic Trial Master File (eTMF) solution. Trial Interactive offers access to global project documentation, get rid of much of the travel ...
Tags: company cooperation, clinical solution, web-based clinical platform
Pharmaceutical and diagnostic company Prometheus Laboratories has granted an oncology programme to Clinipace Worldwide, a global digital research organization (dCRO). As part of the contract, Clinipace Worldwide will study Proleukin ...
Tags: medical research, data management platform, clinical trial
Metagenics, a nutrigenomics and lifestyle medicine company, has unveiled NutraGems CoQ10 300 chewable gels. The gels provide an emulsified delivery form of coenzyme Q10 designed for enhanced absorption, the company said. Metagenics ...
Tags: Chewable Gels, cellular energy, proteins
AbD Serotec, MorphoSys' division for research and diagnostic antibodies, is set to introduce a series of the human combinatorial antibody library (HuCAL) anti-drug antibodies supporting the development of novel antibody therapeutics. The ...
Tags: AbD Serotec, HuCAL Anti-Drug Antibodies, antibody therapeutics, MorphoSys
Clinical research organization PRA has opened a second office in China to house its continued expansion in China and the Asia Pacific region. The new Beijing facility is expected to enhance PRA local project teams' ability in meeting the ...
Tags: Clinical research, clinical drug development, clinical sites