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In Vitro Diagnostics News

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391-405 of 2993 results
Roche gets FDA liquid biopsy approval for cobas EGFR mutation test v2
By MDBR Staff Writer
Roche has received liquid biopsy approval from the US Food and Drug Administration (FDA) for cobas EGFR mutation test v2 for use with plasma samples, as a companion diagnostic for the non-small cell lung cancer (NSCLC) therapy.
Diagnostics > In Vitro Diagnostics > News
ArcherDX, Illumina to develop NGS-based in vitro diagnostic tests
By MDBR Staff Writer
ArcherDX has partnered with Illumina to develop next-generation sequencing (NGS)-based in vitro diagnostic (IVD) tests.
Diagnostics > In Vitro Diagnostics > News
WHO recommends rapid test for extensively resistant tuberculosis
By MDBR Staff Writer
On 12 May 2016 the WHO published a recommendation for the rapid tuberculosis test from the company Hain Lifescience.
Diagnostics > In Vitro Diagnostics > News
Roche introduces CoaguChek INRange self-testing device
By MDBR Staff Writer
Roche has introduced the new CoaguChek INRange system self-testing device which helps patients to spend more time in therapeutic range with minimal training.
Diagnostics > In Vitro Diagnostics > News
Quest Diagnostics introduces three new cancer test services
By MDBR Staff Writer
Quest Diagnostics has introduced three new cancer test services, which will enable clinicians to predict the development of hereditary forms of cancer in individuals.
Diagnostics > In Vitro Diagnostics > News
European Union agrees new rules on medical devices
By MDBR Staff Writer
The European Union (EU) has agreed new rules on medical devices and in vitro diagnostic medical devices.
Diagnostics > In Vitro Diagnostics > News
FDA approves Roche’s CMV test for use in hematopoietic stem cell transplant recipients
By MDBR Staff Writer
The US Food and Drug Administration (FDA) has approved Roche’s cytomegalovirus (CMV) test for use in hematopoietic stem cell transplant recipients.
Diagnostics > In Vitro Diagnostics > News
Biocept announces master services agreement with pharma company to develop liquid biopsy tests
By MDBR Staff Writer
Biocept, a leading molecular diagnostics company with liquid biopsy technology for cancer profiling and monitoring, announces that it has entered into a master services agreement with a biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets.
Diagnostics > In Vitro Diagnostics > News
Aurora Diagnostics to offer PD-L1 tissue assay for TECENTRIQ
By MDBR Staff Writer
LMC Pathology Services, the Aurora Diagnostics lab in Las Vegas, Nevada, was chosen by Ventana Medical Systems, a Roche Diagnostics Company, as one of the first laboratories in the United States to provide the FDA-approved VENTANA PD-L1 (SP142) Assay.
Diagnostics > In Vitro Diagnostics > News
Bone Index receives FDA 510(k) clearance for Bindex point-of-care instrument
By MDBR Staff Writer
Bone Index, one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.
Diagnostics > In Vitro Diagnostics > News
Siemens Healthineers acquires German firm Neo New Oncology
By MDBR Staff Writer
Siemens Healthineers has acquired Germany-based Neo New Oncology to expand its diagnostics portfolio.
Diagnostics > In Vitro Diagnostics > News
Luminex to buy molecular diagnostic solutions provider Nanosphere
By MDBR Staff Writer
Biotechnology company Luminex has signed an agreement to acquire the US-based molecular diagnostic solutions provider Nanosphere in an all-cash transaction valued at about $58m.
Diagnostics > In Vitro Diagnostics > News
Santrax point-of-care solution released
By MDBR Staff Writer
Sandata Technologies, a leading national provider of information technology solutions to the home care industry, announces the release of the next generation of its mobile workforce solution, Santrax Point-of-Care (SPoC).
Diagnostics > In Vitro Diagnostics > News
Dako announces expanded use of PD-L1 diagnostic test in Europe
By MDBR Staff Writer
Dako, Agilent Pathology Solutions, a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy, announced an expansion of the intended use of the PD-L1 IHC 28-8 pharmDx test in Europe to include patients with melanoma cancer.
Diagnostics > In Vitro Diagnostics > News
Illumina registers MiSeqDx system in South Korea
By MDBR Staff Writer
Illumina announced it has received a product approval certificate for the MiSeqDx Instrument and the MiSeqDx Universal Kit with the Ministry of Food and Drug Safety (MFDS) in South Korea.
Diagnostics > In Vitro Diagnostics > News
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