In Vitro Diagnostics News and Research

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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

Instrumentation Laboratory announces European release of HemosIL Rivaroxaban Testing Solution

Instrumentation Laboratory today announced the commercialization of their HemosIL Rivaroxaban Testing Solution in Europe. The HemosIL Liquid Anti-Xa assay, when used in conjunction with HemosIL Rivaroxaban Calibrators and HemosIL Rivaroxaban controls offers an automated solution for measurement of rivaroxaban.

10 Aug 2015

Corgenix Medical to present several scientific abstracts at 2015 AACC Clinical Lab Expo

Corgenix Medical Corporation, the U.S. - based operation of ORGENTEC Diagnostika, is presenting several scientific abstracts at the 2015 American Association for Clinical Chemistry Clinical Lab Expo in Atlanta. Three abstracts involve the ReEBOV Ebola rapid diagnostic test (RDT) with a fourth abstract involving the AtherOx™ Assay for assessing heart disease risk.

25 Jul 2015

QIAGEN's therascreen EGFR RGQ PCR Kit to guide use of IRESSA for in NSCLC treatment

QIAGEN N.V. today received U.S. marketing (PMA) approval of its therascreen EGFR RGQ PCR Kit (therascreen EGFR test) as a companion diagnostic to guide the use of AstraZeneca's IRESSA (gefitinib) in the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC).

From QIAGEN Manchester Limited 14 Jul 2015

Kalorama Information: NGS diagnostics can detect any number of genetic variants

Next generation sequencing may be able to bypass some of the downside of molecular testing and in doing so earn its place in clinical testing, according to Kalorama Information.

30 Jun 2015

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, part of the National Institutes of Health, to create reference materials and positive controls for cancer assays.

26 Jun 2015

In Vitro Diagnostics News and Research

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

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

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

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

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

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

Oxford Gene Technology launches Cytocell FISH probe for bladder cancer

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

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

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

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

Instrumentation Laboratory announces European release of HemosIL Rivaroxaban Testing Solution

Corgenix Medical to present several scientific abstracts at 2015 AACC Clinical Lab Expo

QIAGEN's therascreen EGFR RGQ PCR Kit to guide use of IRESSA for in NSCLC treatment

Kalorama Information: NGS diagnostics can detect any number of genetic variants

SeraCare Life Sciences inks CRADA with NCI to create positive controls for cancer assays

IDT’s fully licensed MGB Eclipse qPCR probes available for online ordering

Roche unveils series of new diagnostic technologies at EuroMedLab

Hitachi High-Technologies, QIAGEN form new strategic partnership to advance molecular testing

Supporting Innovation in Life Sciences

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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