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In Vitro Diagnostics News

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Biophor Diagnostics announces FDA 510(k) clearance for its seventh oral fluid screening assay
By MDBR Staff Writer
Biophor Diagnostics announces that it has received FDA 510(k) clearance for sale and distribution of its seventh oral fluid screening assay based on the RapidFRET IVD Platform technology.
Diagnostics > In Vitro Diagnostics > News
MedMira’s Reveal G4 Rapid HIV-1 antibody test gets FDA approval
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for MedMira’s rapid HIV test, Reveal G4 Rapid HIV-1 antibody test.
Diagnostics > In Vitro Diagnostics > News
Luminex obtains CE-IVD mark for NxTAG respiratory pathogen panel
By MDBR Staff Writer
Luminex has received CE-IVD mark approval for its NxTAG respiratory pathogen panel, which can detect 21 clinically-relevant viral and bacterial respiratory pathogens.
Diagnostics > In Vitro Diagnostics > News
Pressure BioSciences and FIU to develop new PCT-based rape kit test method
By MDBR Staff Writer
Pressure BioSciences (PBI) has signed a collaborative research and development agreement with Florida International University (FIU) to develop a novel rape kit test method, based on its pressure cycling technology (PCT) platform.
Diagnostics > In Vitro Diagnostics > News
Affymetrix to sell Luminex's multiplexed assay platforms
By MDBR Staff Writer
Affymetrix has entered into a distribution agreement with Luminex to supply its multiplexed assay platforms in the Americas, Asia and Europe.
Diagnostics > In Vitro Diagnostics > News
Ortho Clinical obtains CE mark for high-volume blood analyser
By MDBR Staff Writer
Vitro diagnostics company Ortho Clinical Diagnostics has obtained CE mark for its automated blood analyser Ortho Vision Max, paving the way for its sale in Europe and Japan.
Diagnostics > In Vitro Diagnostics > News
GHO Capital buys DNA Diagnostics Center for $110m
By MDBR Staff Writer
Healthcare investor GHO Capital has acquired DNA-based diagnostic services provider DNA Diagnostics Center (DDC), from MTS Health Investors for around $110m (€104m).
Diagnostics > In Vitro Diagnostics > News
FDA approves Dako's new test for non-squamous carcinoma
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has granted approval for Dako’s PD-L1 IHC 28-8 pharmDx immunohistochemistry test for its use as a complementary diagnostic for non-squamous non-small cell carcinoma
Diagnostics > In Vitro Diagnostics > News
BioNano and UCLA to study structural variations in human genetic pediatric disorders
By MDBR Staff Writer
Genome analysis tools provider BioNano Genomics has signed a research collaboration agreement with the University of California, Los Angeles (UCLA), to undertake research on the role of structural variations in human genetic pediatric disorders.
Diagnostics > In Vitro Diagnostics > News
Roche launches new cobas c 513 analyser
By MDBR Staff Writer
Roche announced that its new, dedicated high-throughput HbA1c testing solution, the cobas c 513 analyser, is now available for countries accepting the CE mark.
Diagnostics > In Vitro Diagnostics > News
Immunovia, OHSU collaborating on early detection test for pancreatic cancer
By MDBR Staff Writer
Immunovia and the Knight Cancer Institute at Oregon Health & Science University (OHSU) formed a collaboration to confirm, validate and commercialize a blood test for the early diagnosis of pancreatic cancer.
Diagnostics > In Vitro Diagnostics > News
Amoy Diagnostics and Illumina enter strategic collaboration for next-generation sequencing cancer diagnostics in China
By MDBR Staff Writer
Amoy Diagnostics announced a strategic collaboration to accelerate the adoption of precision medicine and targeted therapies in China.
Diagnostics > In Vitro Diagnostics > News
Merck and Pfizer partner with Dako to develop companion diagnostic test for avelumab
By MDBR Staff Writer
Merck and Pfizer have collaborated with Agilent Technologies firm Dako to develop a potential companion diagnostic test (CDx) for an investigational immune checkpoint inhibitor avelumab.
Diagnostics > In Vitro Diagnostics > News
Medtronic initiates global study of minimally invasive technology to aid lung cancer diagnosis
By MDBR Staff Writer
Medtronic's Minimally Invasive Therapies Group recently launched a 2,500-patient, international study to assess real-world impact of its superDimension navigation system.
Diagnostics > In Vitro Diagnostics > News
VolitionRx announces CE mark for NuQ blood assay for detection of colorectal cancer
By MDBR Staff Writer
VolitionRx announced that the company's first CE mark for its blood-based diagnostic assay, NuQX001S, for detection of colorectal cancer.
Diagnostics > In Vitro Diagnostics > News
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