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Roche Diagnostics responds to HPV announcement

Roche Diagnostics welcomes the announcement by Public Health Minister, Jane Ellison, to introduce Human Papillomavirus (HPV) primary screening in England.

6 Jul 2016

Comprehensive NMR profiling module for detailed lipoprotein subclass analysis announced by Bruker (research use only)

At the 12th Annual Conference of the Metabolomics Society (www.metabolomics2016.org), Bruker announces a new, more comprehensive, more efficient and easy-to-use profiling module for detailed lipoprotein subclass analysis using Nuclear Magnetic Resonance (NMR).

From Bruker BioSpin - NMR, EPR and Imaging 1 Jul 2016

NMR-based metabolomics: an interview with Prof. Claudio Luchinat

Professor Claudio Luchinat, University of Florence and co-founder of the Magnetic Resonance Center (CERM), speaks to News-Medical about his research in NMR-based metabolomics.

From Bruker BioSpin - NMR, EPR and Imaging 9 Jun 2016

FDA approves blood-based cobas EGFR Mutation Test v2 for NSCLC patients

The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients.

2 Jun 2016

OGT launches Cytocell FISH probes for glial tumours

Oxford Gene Technology (OGT), The Molecular Genetics Company, has launched its CE-IVD labelled Cytocell Aquarius® 1p36/1q25 and 19q13/19p13 Deletion Probe Kit*, a cost-effective fluorescence in situ hybridisation (FISH) kit for the reliable investigation of glial tumours.

4 May 2016

Renishaw inVia to support development of nanomolecular probes in Kircher Laboratory at Memorial Sloan Kettering

The Kircher laboratory at Memorial Sloan Kettering is developing novel nanoprobes for molecular imaging, image-guided therapy and theranostics.

4 Mar 2016

IL obtains 510(k) clearance for ACL TOP Family 50 Series Hemostasis Testing Systems

Instrumentation Laboratory today announced the 510(k) clearance of their latest innovation, the ACL TOP Family 50 Series Hemostasis Testing Systems, by the US Food and Drug Administration.

21 Dec 2015

WHO Prequalification of IVDs Programme accepts Beckman Coulter’s Aquios CL flow cytometer

Beckman Coulter Life Sciences announce that their Aquios CL flow cytometer has been accepted by the World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme. It can now be used specifically for the immunologic assessment of patients having, or suspected of having, immune deficiency.

7 Dec 2015

SkylineDx's MMprofiler receives CE-IVD certification

SkylineDx, today announced they have received CE-IVD registration from the European Competent Authority (Ministry of Health) for the MMprofiler, the company's prognostic test to determine the level of risk of a patient with multiple myeloma (MM).

25 Nov 2015

FDA grants accelerated approval for Tagrisso to treat patients with advanced NSCLC

Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy.

14 Nov 2015

Pittcon will exhibit at the Bioconference clinical diagnostics and research virtual conference

Pittcon is pleased to announce its participation in the “Clinical Diagnostics & Research” virtual conference from November 11 to 12, 2015. Clinicians, researchers, medical experts, and professionals from around the world convene for this free web-conference to learn and interact with a community of like-minded colleagues.

From Pittcon 27 Oct 2015

Biophor receives FDA 510(k) clearance for distribution of seventh oral fluid screening assay

Biophor Diagnostics, Inc. 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. This clearance completes the company's flagship panel for drugs of abuse screening in oral fluid.

19 Oct 2015

Luminex's NxTAG Respiratory Pathogen Panel receives CE-IVD marking

Luminex Corporation today announced that it has received CE-IVD marking for its NxTAG Respiratory Pathogen Panel. The Panel detects 21 clinically-relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila.

19 Oct 2015

FDA permits marketing of first CSF nucleic acid-based test for detection of multiple pathogens

The U.S. Food and Drug Administration today allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central nervous system infections.

12 Oct 2015

Luminex receives rapid clearance from FDA for ARIES System and ARIES HSV 1&2 Assay

Luminex Corporation today announced that it has received FDA clearance for the company's ARIES® System and ARIES HSV 1&2 Assay.

7 Oct 2015

Oxford Gene Technology launches Cytocell FISH probe for bladder cancer

Oxford Gene Technology (OGT), The Molecular Genetics Company, has launched its CE-IVD labelled Cytocell Aquarius® P16/3c/7c/17c Probe Kit, a cost-effective, ready-to-use fluorescence in situ hybridisation (FISH) probe kit for non-invasive detection of bladder cancer — for sale in Europe.

From Oxford Gene Technology 6 Oct 2015

Roche launches the cobas EGFR Mutation Test v2 for use with either plasma or tumour tissue samples

Roche has announced the commercial availability in countries that accept the CE mark1 of the cobas® EGFR Mutation Test v2, the first oncology assay from Roche that utilises either plasma or tumour tissue as a sample. The test identifies 42 mutations in the epidermal growth factor receptor (EGFR) gene, the most of any In-vitro Diagnostic (IVD) on the market, and can also be used as an aid in selecting eligible patients with non-small cell lung cancer (NSCLC) for therapy with an EGFR tyrosine kinase inhibitor (TKI).

From Roche Sequencing and Life Science 28 Sep 2015

BD Life Sciences announces FDA clearance for BD MAX Enteric Parasite Panel

BD Life Sciences, a segment of global medical technology company BD (Becton, Dickinson and Company), today announced the availability of the U.S. Food and Drug Administration cleared BD MAX Enteric Parasite Panel for use on the BD MAX System.

From BD (Becton, Dickinson and Company) 24 Sep 2015

VolitionRx's NuQ blood test receives CE Mark approval for detection of colorectal cancer

VolitionRx Limited today announced the Company's first CE Mark for its blood-based diagnostic assay, NuQ X001S, for detection of colorectal cancer. The NuQ test utilizes the Company's proprietary Nucleosomics technology platform, which identifies and analyses fragments of chromosomes, called nucleosomes, circulating within the blood for the presence of epigenetic cancer signals.

22 Sep 2015

SKY92 genetic subtyping signature better than current markers in predicting progress of multiple myeloma

Article in Blood shows the reliability of SKY92 genetic subtyping signature for prediction of disease progress for multiple myeloma patient.

9 Sep 2015