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65 metabolites in urine simultaneously measured by clinical IEM-by-NMR screening study in Turkey

At the 12th International Congress of Inborn Errors of Metabolism (www.iciem2013.com), Bruker announces another milestone in the cost-effective use of NMR (nuclear magnetic resonance) spectroscopy screening as a clinical research tool for metabolic screening and small molecule in vitro diagnostics (IVD) research and validation.

4 Sep 2013

Mount Sinai, Exosome Partner On Body Fluid Molecular Diagnostics

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22 Aug 2013

FDA approves first mass spectrometer system in U.S. for identification of bacteria, yeasts

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans.

22 Aug 2013

FDA recalls Nova Max Blood Glucose Test Strips due to faulty readings

The U.S. Food and Drug Administration is working with Nova Diabetes Care to recall 21 lots of glucose test strips marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits. Nova Diabetes Care announced a recall on July 26, 2013.

1 Aug 2013

FDA allows marketing of Xpert MTB/RIF Assay for treatment of TB

The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.

26 Jul 2013

EKF Diagnostics introduces STAT-Site M ß-HB strip test for DKA assessment

EKF Diagnostics, the global in vitro diagnostics business, announces the worldwide launch of the new STAT-Site M ß-HB, following successful CE marking.

From EKF Diagnostics 25 Jul 2013

Bruker introduces AVANCE-IVDr platform for NMR clinical research and screening

Bruker today announces a standardized nuclear magnetic resonance (NMR) spectroscopy platform for its clinical and diagnostics partners that enables cost-effective, high-performance NMR clinical screening and IVD-by-NMR discovery, development and validation of novel NMR assays.

24 Jul 2013

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

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