Molecular Diagnostics News and Research

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EKF Diagnostics highlighting cancer molecular diagnostics products at ASCO 2015

EKF subsidiary, Selah Genomics’ newly introduced PrecisionPath™ next generation sequencing (NGS) technology cancer test will be a key focus on Booth #19141...

From EKF Diagnostics 28 May 2015

Roche announces FDA clearance for cobas Cdiff Test to detect C. difficile in stool specimens

Roche announced today that the US Food and Drug Administration has provided 510(k) clearance for the cobas Cdiff Test to detect Clostridium difficile (C. difficile) in stool specimens.

26 May 2015

DF/BWCC introduces new website to provide information about precision cancer medicine

Precision cancer medicine - diagnosis and treatment based on the genetic abnormalities of a specific tumor - is playing an ever-larger role in cancer care. The field got a boost earlier this year when President Barack Obama proposed a $215 million federal Precision Medicine Initiative with cancer as one of its priorities.

21 May 2015

Corus CAD test can help clinicians rule-out low-risk patients from additional cardiac testing

CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced today results from a multi-center, community-based patient registry, the PRESET Registry, evaluating the use of the Corus CAD test in patients with symptoms suggestive of obstructive coronary artery disease (CAD) in the primary care setting.

20 May 2015

Studies support use of ThyraMIR and ThyGenX to improve detection of benign/malignant thyroid nodules

Data will be presented at both Digestive Disease Week (DDW) and the American Association of Clinical Endocrinologists (AACE) annual medical meetings.

18 May 2015

Roche announces FDA approval of cobas KRAS Mutation Test for diagnostic use

Roche today announced that the U.S. Food and Drug Administration has approved the cobas KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.

11 May 2015

Mobidiag to present two new diagnostic platforms for infectious diseases at ECCMID 2015

Mobidiag Ltd, a Finnish molecular diagnostics company specializing in the development of innovative diagnostics solutions for infectious diseases, today announced the first public presentation of two new diagnostic platforms – Novodiag and Amplidiag Easy – at ECCMID 2015 in Copenhagen on April 25-28.

24 Apr 2015

AMP report provides overview of current research on minimally invasive 'liquid biopsy' approaches

The Association for Molecular Pathology, the premier global, non-profit organization serving molecular diagnostic professionals, today published a special article in The Journal of Molecular Diagnostics titled, "Do Circulating Tumor Cells, Exosomes, and Circulating Tumor Nucleic Acids Have Clinical Utility?" The report provides a thorough overview of research to-date on the minimally invasive "liquid biopsy" approaches to cancer diagnostics.

23 Apr 2015

Data presented at AACR 2015 recognizes value of EKF PointMan technology for assessing lung cancer mutation status

The PointMan EGFR DNA enrichment kit, a novel method for selective amplification of genotype specific sequences.

From EKF Diagnostics 21 Apr 2015

Focus Diagnostics announces FDA clearance for Simplexa Group A Strep Direct Kit

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, today announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit. Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs.

From Quest Diagnostics 15 Apr 2015

Atlas Genetics signs diagnostic collaboration to explore new use of io system

Atlas Genetics Ltd, the ultra-rapid 'test and treat' molecular diagnostics company, today announces that it has entered into a collaboration with a major pharmaceutical company to develop a diagnostic test, expanding capabilities beyond infectious diseases.

15 Apr 2015

New data support use of Exalenz Bioscience's BreathID test for diagnosing H. pylori infection

Exalenz Bioscience, a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, today announced new published data supporting the use of the Company's point-of-care BreathID urea breath test for diagnosing Helicobacter pylori infection (H. pylori) in the emergency department (ED) setting.

13 Apr 2015

MammaPrint 70-gene breast cancer recurrence assay recommended in Germany’s AGO Guidelines

Agendia, a leading molecular diagnostics company that develops and markets genomic diagnostic products, announced at the St. Gallen International Breast Cancer Conference that new guidelines of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) recommend the MammaPrint® 70-gene breast cancer recurrence assay in Germany’s 2015 guidelines for early-stage invasive breast cancer.

9 Apr 2015

Mobidiag announces CE-IVD marking and launching of Amplidiag C. difficile+027 test

Mobidiag Ltd, a Finnish molecular diagnostics company specialized in the development of innovative diagnostics solutions for infectious diseases, today announced the launch of Amplidiag C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of C. difficile infection (CDI).

9 Apr 2015

Frost & Sullivan forecasts growth of global healthcare market

The healthcare industry is entangled in a transitory phase in which therapeutics, devices, products and services are sold into traditional care settings that are unable to keep up with the requirements placed upon it by changing demographics and consumer needs. At the same time, opportunities for new services and care, such as ambulatory, mobile, and home care, lack the appropriate level of maturity to provide robust revenue streams despite having the promise to increase healthcare delivery efficiency and reduce long term costs.

8 Apr 2015

Cepheid's Xpert Ebola diagnostic test granted FDA Emergency Use Authorization

Cepheid today announced it has received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpert Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours.

25 Mar 2015

Sigma-Aldrich, Roche sign distribution agreement for Biochemical Reagents products

Sigma-AldrichCorporation, a leading Life Science and Technology company, announced today it signed an exclusive global distribution agreement with Roche. The agreement pairs Roche's high-quality Biochemical Reagents product portfolio with the industry-leading eCommerce and supply chain capabilities of Sigma-Aldrich.

19 Mar 2015

Fast and focused sequencing from single genes to entire exomes

Integrated DNA Technologies (IDT) will host a talk on maximizing efficiency of NGS enrichment panels at the qPCR & NGS 2015 Advanced Molecular Diagnostics for Biomarker Discovery Symposium on Monday March 23rd at 3PM. The talk will detail current technical issues faced by researchers when using hybridization enrichment panels and provide practical advice on how to increase successes while reducing time and costs in targeted sequencing.

From Integrated DNA Technologies 16 Mar 2015

NMR screening solution specifically for the analysis of honey launched by Bruker

This new NMR screening solution specifically for the analysis of honey is the most recent module of Bruker’s well-established FoodScreener™ product line to be released in April.

From Bruker 10 Mar 2015

Wine-Profiling solution based on NMR introduced by Bruker

This substantially enhanced second-generation module of the FoodScreener™ for wine profiling allows easy and cost-efficient NMR-based wine analysis, now for the first time also for key regions in France, Italy and Spain. In addition to geographical origin, NMR Wine Profiling can determine further key authenticity parameters such as grape variety, vintage year and possible water addition. This comprehensive solution offers a quick, fully automated and cost-efficient tool to ensure wine quality and authenticity, protecting brand integrity and consumer confidence.