Bruker-Hain Diagnostics has a portfolio of DNA/RNA extraction and preparation systems and kits.
The genesig real-time PCR Coronavirus (COVID-2019) CE-IVD assay is validated for use on Bruker-Hain Diagnostics GenoXtract (GXT) automated nucleic acid extraction devices with associated extraction kits.
Shipments to Spain, France, Germany and the UK have already started.
The genesig assay has been validated for respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, sputum) on commonly available laboratory thermocyclers. The kit includes all necessary reagents to produce up to 96 results in under two hours.
The genesig assay is designed for very high specificity for the 2019-nCoV virus strain that is implicated in COVID-19. The genesig test is CE-IVD marked and intended for in vitro diagnostic use in Europe.
Bruker-Hain Diagnostics is focused on Molecular Diagnostics products within Bruker´s Microbiology and Diagnostics business.
Hain Lifescience GmbH is the legal manufacturer of the Fluorocycler XT, MTBDR 2.0 assay and of GXT nucleic acid preparation kits.
Bruker's high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels.
In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.
Viatris receives Japanese approval for WAKIX in narcolepsy and sleep apnoea
WHO identifies SynAct Pharma's resomelagon among six dengue drug candidates
Japan approves subcutaneous Leqembi formulation for early Alzheimer's disease
Japan approves Lundbeck's eptinezumab for preventive migraine treatment
Skyhawk Therapeutics reports final results from Phase 1/2 trial in Huntington's disease
GSK to acquire trispecific T cell-engager from Chimagen for multiple myeloma
Kelun-Biotech publishes phase III data for trastuzumab botidotin in HER2-positive breast cancer
FDA grants priority review to Takeda's zasocitinib application for plaque psoriasis
Armata Pharmaceuticals announces receipt of FDA Breakthrough Therapy Designation for AP-SA02
AstraZeneca's Etcamah misses primary endpoint in Phase III breast cancer trial
GSK reports positive Jideytro data supporting potential first-line lung cancer use
Eloxx Pharmaceuticals commences Phase 2b study of exaluren
Akeso presents positive results from registrational Phase III study of ivonescimab
FDA grants Priority Review to Genentech's Enspryng for MOGAD