Molecular Diagnostics News and Research

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New test to assess viral load of cytomegalovirus

Roche announced today the commercial availability of a new test to assess a patient's viral load of cytomegalovirus (CMV). Physicians use information from the test to help them manage patients who have been diagnosed with CMV disease, specifically patients with an immune system that has been suppressed for solid organ transplantation.

From Roche Sequencing and Life Science 17 Sep 2012

PrimeraDx’s ICEPlex system and C. difficile detection assay receive CE mark

PrimeraDx, a molecular diagnostics company, announced today that the ICEPlex system, a quantitative multiplex PCR system, and their C. difficile detection assay both received the CE mark.

12 Sep 2012

Ingenuity Systems, ShanghaiBio sign collaboration agreement

ShanghaiBio Corporation and Ingenuity Systems have signed a collaboration agreement enabling ShanghaiBio Corporation to extend its current lab service offering to include Ingenuity solutions for downstream analysis and interpretation of genomics data. ShanghaiBio Corporation will complement their sequencing, genotyping and gene expression lab services by creating a bundled solution with Ingenuity's applications, which combine analytics and biomedical content to help get actionable insights from experiments.

6 Sep 2012

Akonni receives NSF's Phase 2 SBIR Grant to develop Lab-on-a-Film microarray

Akonni Biosystems, a life science tools / molecular diagnostics company that develops, manufactures, and plans to market molecular testing devices for diagnosing infectious diseases and human genetic disorders, announced today the receipt of a $498,780 Phase 2 SBIR Grant from the National Science Foundation (NSF).

6 Sep 2012

New York State Department of Health issues license to Veracyte's Afirma Gene Expression Classifier

Veracyte, Inc., a molecular diagnostics company pioneering the emerging field of molecular cytology, and Genzyme, a Sanofi company, today announced that the New York State Department of Health has issued a license enabling Veracyte's Afirma Gene Expression Classifier to be offered to patients in the state.

30 Aug 2012

NUI Galway project hopes to deliver cost effective tool for rapid diagnosis of pneumonia

Researchers at NUI Galway are involved in a new European project which hopes to deliver a cost effective tool for the speedy diagnosis of infections such as pneumonia. The test would reduce diagnosis time from days to hours, so that the appropriate treatments can be administered as early as possible for the best possible outcome.

29 Aug 2012

U-M, IGC launch new joint venture for personalized medicine

As a key step toward providing patients with treatments based on their own DNA profiles, the University of Michigan and the International Genomics Consortium (IGC) have launched a new joint venture that will help usher in an age of personalized medicine.

17 Aug 2012

MedPage Today, CollabRx sign license agreement for Oncology Next

Tegal Corporation today announced that its recently acquired CollabRx, Inc., subsidiary signed an exclusive license agreement to provide a version of its proprietary Therapy Finder tool to MedPage Today, Everyday Health, Inc.'s rapidly growing online site that serves 96% of all oncologists and 1.6 million monthly online unique users.

9 Aug 2012

Public Health Wales uses Luminex's xTAG GPP for outbreak investigations during Olympic events

Luminex Corporation announced today that Public Health Wales is using Luminex's CE marked xTAG Gastrointestinal Pathogen Panel (GPP) for outbreak investigation activities during Olympic and Paralympic training and events taking place in Wales. Results of a substantial diagnostic validation of the GPP test conducted by The Public Health Wales Microbiology laboratory team at the University Hospital of Wales, Cardiff, are anticipated to be published in a peer reviewed journal

From Luminex 6 Aug 2012

New sequencing approach can provide more effective method of BRCA1/2 mutational analysis

Individuals with mutations in BRCA1 and BRCA2 genes have a significantly higher risk of developing breast and ovarian cancers. Families at risk have been seeking genetic testing and counseling based on their mutation carrier status, but the standard method of direct sequencing is labor-intensive, costly, and it only targets a part of the BRCA1 and BRCA2 genes.

6 Aug 2012

Positive results from Vermillion OVA500 multi-center study for ovarian cancer

Vermillion, Inc., a leading molecular diagnostics company, today announced positive results from a new prospective, multi-center clinical study of its ovarian cancer diagnostic OVA1.

30 Jul 2012

IMDx HSV-1/2 for Abbott m2000 assay receives CE-marking

IntelligentMDx (IMDx) announced today that it has obtained CE-marking for its fourth automated, high-throughput molecular test designed and developed for the Abbott m2000 System.

20 Jul 2012

Life Technologies acquires Navigenics

Life Technologies Corporation today announced the acquisition of Navigenics, Inc. This acquisition represents Life Technologies' first step in executing against a strategy to build out its molecular diagnostics business through internal development, partnerships and select acquisitions.

17 Jul 2012

Luminex to acquire molecular diagnostics company, GenturaDx

Luminex Corporation today announced a definitive agreement to acquire privately-held, GenturaDx, a molecular diagnostics company focused on making nucleic acid testing both affordable and practical for any laboratory. GenturaDx is in late stage development of a fully integrated, highly automated, real-time PCR system that employs a single-use cassette for true sample-to-answer workflow.

From Luminex 9 Jul 2012

FDA approves Roche's new HIV viral load test

Roche announced today that a new HIV viral load test has been approved by the United States Food and Drug Administration (FDA) and will be commercially available in the US later this year.

2 Jul 2012

Evolution of Advanced IVDs Conference to take place on September 19-20, 2012

IVD Technology Magazine announces the Evolution of Advanced IVDs Conference on September 19-20, 2012 at the San Diego Convention Center.

29 Jun 2012

Afirma gene expression test can reduce unnecessary thyroid cancer surgeries

Veracyte, Inc., a molecular diagnostics company that is pioneering the emerging field of molecular cytology, today announced results from a large, prospective, multicenter study, which demonstrated the potential for the Afirma® Gene Expression Classifier, a gene expression test, to reduce the large number of unnecessary surgeries in thyroid cancer diagnosis by more than half.

25 Jun 2012

FDA approves CDC DENV-1-4 Real Time RT PCR Assay to treat dengue

The Centers for Disease Control and Prevention has developed a new diagnostic test to detect the presence of dengue virus in people with symptoms of dengue fever or dengue hemorrhagic fever. The test, called the CDC DENV-1-4 Real Time RT PCR Assay, has been authorized by the Food and Drug Administration for use in the United States and can be performed using equipment and supplies many public health laboratories already use to diagnose influenza.

21 Jun 2012

Variations in microRNA expression within breast tumors can lead to sampling bias

Certain short strands of RNA, known as microRNAs (miRNAs), have been linked to the progression and metastasis of breast cancer and may provide information about prognosis. However, studies of miRNA expression profiles often report conflicting findings. While the potential for using miRNAs in breast cancer diagnosis is promising, scientists report in a new study published online today in The Journal of Molecular Diagnostics that differences in the amount and types of miRNA within breast tumors can be misleading.

15 Jun 2012

Syapse introduces Discovery app to organize R&D data and processes

Syapse announced today the commercial launch of Discovery, its cloud-based application for making omics data actionable in clinical research and development. Discovery combines a powerful platform for aggregating and structuring biomedical data with intuitive data mining, workflow, and reporting features, enabling biopharma and diagnostics companies to leverage the increasing amount of data generated by advanced omics technologies such as next-generation sequencing.

12 Jun 2012