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In Vitro Diagnostics News

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OraSure receives HHS contract to develop its rapid Ebola test
By MDBR Staff Writer
OraSure Technologies has received a $10.4m contract to advance the clinical development of its OraQuick Ebola rapid antigen test.
Diagnostics > In Vitro Diagnostics > News
Asuragen announces launch of CE-IVD BCR-ABL assay
By MDBR Staff Writer
Asuragen announced the commercial launch of its CE-IVD Quantidex BCR-ABL IS CMR Kit for monitoring BCR-ABL1 transcript levels in patients with Chronic Myeloid Leukemia (CML).
Diagnostics > In Vitro Diagnostics > News
BioNTech introduces MammaTyper breast cancer diagnostic test in Europe
By MDBR Staff Writer
BioNTech, along with its subsidiary BioNTech Diagnostics, announced that it has introduced CE-IVD marked breast cancer diagnostic test, MammaTyper, in the Europe.
Diagnostics > In Vitro Diagnostics > News
Sebia’s Capillarys 3 Tera receives CE mark approval for HbA1c and serum protein testing
Sebia has received CE mark approval for Capillarys 3 Tera to use for HbA1c and serum protein testing and immunotyping.
Diagnostics > In Vitro Diagnostics > News
InDevR introduces new Cypher One hemagglutination analysis system
By MDBR Staff Writer
Life science firm InDevR has introduced new hemagglutination analysis system, Cypher One, which will allow to improve vaccine characterization.
Diagnostics > In Vitro Diagnostics > News
Linkage Biosciences announces CE Mark for real-time PCR HLA Test
By MDBR Staff Writer
Linkage Biosciences, a global leader in the field of transplant diagnostics, announced that the LinkSēq Human Leukocyte Antigen (HLA) test is now available with CE mark.
Diagnostics > In Vitro Diagnostics > News
Roche to develop companion diagnostic for DalCor’s therapeutic
By MDBR Staff Writer
Switzerland-based Roche has signed an agreement to develop a companion diagnostic (CDx) test for DalCor Pharmaceuticals’ therapeutic dalcetrapib.
Diagnostics > In Vitro Diagnostics > News
Luminex starts Aries GBS assay clinical trials
By MDBR Staff Writer
Luminex has started clinical and analytical trials to assess its Aries Group B Streptococcus (GBS) assay.
Diagnostics > In Vitro Diagnostics > News
Bio-Techne to buy control solutions provider Cliniqa
By MDBR Staff Writer
Bio-Techne has agreed to purchase Cliniqa, which manufactures and markets quality controls, calibrators and bulk reagents used in the clinical diagnostic market.
Diagnostics > In Vitro Diagnostics > News
Roche’s cobas Cdiff Test receives FDA 510(k) approval
By MDBR Staff Writer
Switzerland-based Roche has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.
Diagnostics > In Vitro Diagnostics > News
ArcherDX launches two new FusionPlex panels
By MDBR Staff Writer
ArcherDX expanded its Archer FusionPlex assay menu to include the FusionPlex Lung Thyroid Panel and FusionPlex Solid Tumor Panel.
Diagnostics > In Vitro Diagnostics > News
Exact Sciences and MD Anderson Cancer Center to develop screening and diagnostic tests for lung cancer
By MDBR Staff Writer
Exact Sciences and The University of Texas MD Anderson Cancer Center announced an agreement to jointly develop and commercialize blood-based screening and diagnostic tests for the early detection of lung cancer
Diagnostics > In Vitro Diagnostics > News
Chembio obtains CE mark approval for DPP HIV 1/2 assay
By MDBR Staff Writer
US-based point-of-care (POC) diagnostic tests provider Chembio Diagnostics has received CE mark approval for its DPP HIV 1/2 assay.
Diagnostics > In Vitro Diagnostics > News
Bruker launches new Maldi Tissuetyper solution
By MDBR Staff Writer
US-based Bruker has introduced new Maldi Tissuetyper solution, which facilitates use of rapifleX Maldi-TOF Mass Spectrometry system for anatomical pathology research.
Diagnostics > In Vitro Diagnostics > News
Studies presented at 2015 ASCO meeting demonstrate predictive power of bioTheranostics’ BCI molecular test
By MDBR Staff Writer
bioTheranostics announced results from studies being presented at the 2015 American Society of Clinical Oncology (ASCO) meeting reinforcing the role its Breast Cancer Index (BCI) molecular test plays in informing decisions about extending endocrine therapy beyond five years post-diagnosis for patients with early stage, estrogen receptor-positive (ER+) breast cancer.
Diagnostics > In Vitro Diagnostics > News
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