In Vitro Diagnostics News and Research

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Cell therapies may stop or reverse pain and disability of degenerative disc disease

Cell therapies may stop or reverse the pain and disability of degenerative disc disease and the loss of material between vertebrae, according to Duke University scientists.

17 Jul 2013

FDA approves Gilotrif for patients with late stage non-small cell lung cancer

Companion test also approved to identify appropriate patients The U.S. Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Lung cancer is the leading cause of cancer-related death among men and women.

16 Jul 2013

PrenaTest can be now performed for high risk pregnancies after ninth week

PrenaTest, Europe's first non-invasive molecular genetic blood test to determine fetal trisomies 13, 18 and 21 in the mother's blood can now be performed for high risk pregnancies after the ninth week (W 9 + D 0).

11 Jul 2013

BHR to demonstrate EKF Quo-Test HbA1c analyser at Heart UK's conference

EKF, announces today that the Quo-Test, its glycated haemoglobin analyser for near-patient monitoring of diabetes will be on show at Heart UK.

From EKF Diagnostics 2 Jul 2013

Abbott RealTime HCV Genotype II assay receives FDA approval

The U.S. Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus that a patient is carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient's blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment.

21 Jun 2013

Mendor's groundbreaking diabetes management platform receives CE mark

Finnish diabetes technology company Mendor announces today the CE mark for its groundbreaking diabetes management platform, Mendor Balance. This cloud-based platform seeks to introduce significant benefits to all the key stakeholders: patients, health care professionals, payers and the pharma industry.

18 Jun 2013

Solution-based circuit chip for rapid, multiplexed detection of pathogens

Life-threatening bacterial infections cause tens of thousands of deaths every year in North America. Increasingly, many infections are resistant to first-line antibiotics. Unfortunately, current methods of culturing bacteria in the lab can take days to report the specific source of the infection, and even longer to pinpoint the right antibiotic that will clear the infection.

13 Jun 2013

BioFire Diagnostics' FilmArray Blood Culture Identification Panel receives CE IVD Mark

BioFire Diagnostics, Inc. announced today that it obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its FilmArray Blood Culture Identification Panel.

6 Jun 2013

FDA approves Tina-quant HbA1cDx assay for diagnosis of diabetes

Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals.

24 May 2013

AB SCIEX launches 3200MD CE-IVDD series in Europe for in vitro diagnostic use

AB SCIEX, a global leader in analytical technologies, today announced the launch of the 3200MD CE-IVDD series for general in vitro diagnostic use in Europe.

20 May 2013

Transgenomic launches new mutation detection test for patients with metastatic colorectal cancer

Transgenomic, Inc. today announced the global, commercial availability of CRC RAScan, a new mutation detection test to screen patients with metastatic colorectal cancer for RAS mutations (KRAS and NRAS).

16 May 2013

Theradiag obtains CE mark for proprietary anti-CCP IVD kit in rheumatoid arthritis

Theradiag, a company specializing in theranostic and in vitro diagnostics, today announced it has obtained a CE mark for its proprietary anti-CCP in vitro diagnostic kit in rheumatoid arthritis.

23 Apr 2013

Luminex's MAGPIX instrument gets FDA approval

Luminex Corporation today announced it has received U.S. FDA clearance of its MAGPIX instrument, with its xTAG Gastrointestinal Pathogen Panel.

From Luminex 16 Apr 2013

FDA lengthens review periods for IVD tests that utilize molecular biomarkers

FDA review periods are lengthening for IVD tests that utilize molecular biomarkers, and at a faster rate than for IVDs overall, one of the key findings in a new report published this month by Amplion Research.

11 Apr 2013

First multi-gene DNA sequencing test launched for cancer patients

The first multi-gene DNA sequencing test that can help predict cancer patients' responses to treatment has been launched in the National Health Service, thanks to a partnership between scientists at the University of Oxford and Oxford University Hospitals NHS Trust.

26 Mar 2013

Dako, Panagene sign supply agreement for PNA oligomer component

Panagene announced it has signed a supply agreement with Dako Denmark A/S to supply PNA oligomer key component for incorporation into Dako's diagnostic or research products. Dako, an Agilent Technologies Company since June 2012, is a leading global provider of tissue-based cancer diagnostic solutions.

22 Feb 2013

Theradiag’s new biotherapy monitoring kits receive CE mark approval

Theradiag, a company specializing in theranostic and in vitro diagnostics, today announced it has obtained a CE mark for two new biotherapy monitoring kits; Tocilizumab (anti-IL6R) and Rituximab (anti-CD20) that further expand the Lisa Tracker range.

14 Feb 2013

Novartis receives FDA approval for Exjade to treat chronic iron overload in NTDT patients

The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

23 Jan 2013

GeneDiagnostics, WILEX partner to commercialize serum HER-2/neu ELISA test in China

WILEX AG today announced that its US subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive distribution agreement with GeneDiagnostics Inc. for the commercialization of the serum HER-2/neu ELISA test in China.

23 Jan 2013

Debiopharm, Spinomix announce closing of Series A equity financing

Debiopharm Group (Debiopharm) and Spinomix SA, a Swiss company advancing molecular diagnostic technologies, announced the closing of a Series A equity investment of $ 3 Million.

9 Jan 2013