In vitro diagnostic company Venaxis has filed for CE mark approval of blood-based appendicitis test, APPY1, in Europe. The company expects to receive CE Mark by the end of 2012 and anticipates initiating commercialization in first quarter ...
Tags: appendicitis test, blood based appendicitis test, FDA, Venaxis
The biotechnology and personalized medicine company, Epistem, has gained CE mark for its in vitro diagnostic medical device (CE-IVD), Genedrive Tuberculosis (TB) test. Epistem said the registration enables to place its TB test and ...
Tags: Epistem, CE mark, CE-IVD, diagnostic medical device, TB test
Mediterranea, an in vitro diagnostic (IVD) equipment company, has agreed to market and sell DiaSys' Parasys Parasite Analyser and RS 2005 Urine Sediment Workstation, and Midi Parasep SF Faecal Parasite Concentrator tubes. Under the ...
Tags: Mediterranea, agreement, DiaSys'equipments
Mediterranea, a distributor of in vitro diagnostic equipments, has entered into a collaboration agreement with DiaSys. Under the agreement, Mediterranea will market and sell DiaSys' Parasys Parasite Analyser and RS 2005 Urine Sediment ...
VelaDx has signed a license and supply agreement with Life Technologies to develop new sequencing-based in vitro diagnostic (IVD) tests on the Ion Personal Genome Machine (PGM) sequencer. Under the agreement, VelaDx will seek approvals ...
Tags: sequencing-based in vitro diagnostic tests, IVD tests, Ion PGM sequencer
Saladax Biomedical has received CE mark for its MyPaclitaxel and MyDocetaxel therapeutic dose management (TDM) MyCare assays, enabling commercialisation in the European Union (EU). Both paclitaxel and docetaxel are administered based on a ...
Tags: Saladax Biomedical, Saladax's MyCare technology platform, MyCare tests
Mediterranea, a distributor of in vitro diagnostic (IVD) equipments, has entered into an agreement to market and sell DiaSys' Parasys Parasite Analyser and RS 2005 Urine Sediment Workstation, and Midi Parasep SF Faecal Parasite Concentrator ...
Tags: medical equipement, company cooperation, vitro diagnostic
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
Sphere Medical has presented positive results of its in-vitro diagnostic medical device designed for measuring intravenous anaesthetic propofol at the point of care. The device, Pelorus 1500, provides real time measurements of propofol ...
Tags: Sphere Medical, medical device
Fluxion Biosciences has introduced an instrument to isolate rare circulating tumor cells (CTC) which disseminate from primary tumors and circulate throughout the peripheral blood. Using the proprietary microfluidic technology, the IsoFlux ...
Tags: CTC instrument, IsoFlux System, medical device, Class I medical device
Affymetrix and PathGEN Dx have entered into an agreement for the development of an in-vitro diagnostic kit for pathogen detection. Under the agreement, PathGEN Dx will use its PathGEN PathChip for the development of the kit, designed to ...
Tags: in-vitro diagnostic kit, kit for pathogen detection, samples
Novation has awarded a two year supplier agreement to a manufacturer of in vitro diagnostic products, Hycor Biomedical. Under the agreement, Hycor will provide more than 65,000 members served by Novation including VHA, UHC, two national ...