Molecular Diagnostics News and Research

RSS

New technology can detect KRAS gene mutations, facilitate targeted therapies for lung and colorectal cancers

A new technology suitable for practical clinical testing can detect KRAS gene mutations in lung and colorectal cancers and could thereby facilitate targeted therapies, according to a new report in The Journal of Molecular Diagnostics.

8 Jun 2016

Study assesses utility of tumor cfDNA as predictor of therapeutic response to immunotherapy

Chronix Biomedical, Inc., a developer of blood-based molecular diagnostics, today announces positive data from a blinded proof of concept clinical study, assessing the utility of tumor cell-free DNA as a predictor of therapeutic response to immunotherapy after the first cycle of treatment in eight different types of cancer.

20 May 2016

Epigenomics receives FDA approval for Epi proColon®

Epigenomics AG, the German-American cancer molecular diagnostics company, has announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s lead product, Epi proColon®, the first and only FDA-approved blood-based colorectal cancer screening test.

14 Apr 2016

Advanced assay offers better sensitivity for detecting a prion disease affecting elk

Transmissible spongiform encephalopathies (TSEs), or prion diseases, are a family of rare progressive, neurodegenerative illnesses that affect both humans and animals. TSE surveillance is important for public health and food safety because TSEs have the potential of crossing from animals to humans, as seen with the spread of mad cow disease, or bovine spongiform encephalopathy (BSE). A study in The Journal of Molecular Diagnostics describes an advanced assay that offers better sensitivity than currently available tests for detecting a prion disease affecting elk.

11 Apr 2016

Clinical study shows association between Corus CAD blood test scores and cardiovascular event rates

CardioDx, Inc., a molecular diagnostics company specializing in cardiovascular genomics, announced today results from a genomic substudy of the NHLBI-funded Prospective Multicenter Imaging Study for Evaluation of Chest Pain (PROMISE) trial in nondiabetic patients receiving the Corus CAD blood test.

7 Apr 2016

Myriad myRisk Hereditary Cancer test identifies 70% more deleterious mutations than BRCA1/2 testing alone

Myriad Genetics, Inc., a leader in molecular diagnostics and personalized medicine, working in collaboration with researchers from the Harvard Medical School, today announced that the Journal of Clinical Oncology has published a paper showing the frequency of germline mutations in 25 cancer susceptibility genes among patients with breast cancer.

31 Mar 2016

New device can deliver diagnosis to patient in 30 minutes

When a person contracts a disease, it takes time to diagnose the symptoms. Cell culturing, immunoassay and a nucleic-acid based diagnostic cycle all take several days, if not a week to determine the results. Not only do sick patients suffer during this time period, the wait can also lead to unnecessary disease spreading and perhaps avoidable antibiotic use.

30 Mar 2016

AMP disappointed as FDA takes enforcement action against physicians for Zika virus test

The Association for Molecular Pathology, the premier global, professional society serving molecular diagnostics professionals, is very concerned and disappointed to see the FDA taking enforcement action against the physicians at Texas Children's Hospital and Houston Methodist Hospital for their laboratory developed procedure (LDP) for Zika virus, which was designed to identify virus-specific RNA sequences in a large metropolitan area.

16 Mar 2016

Texas Children's Hospital, Houston Methodist Hospital jointly release country's first rapid test for Zika virus

Collaboration between two Texas Medical Center institutions has resulted in today's release of the country's first hospital-based rapid tests for the Zika virus.

23 Feb 2016

New personalized DNA-based digital assay has potential to dramatically impact CML management

The outcomes of chronic myeloid leukemia (CML) have dramatically improved as the result of tyrosine kinase inhibitor (TKI) treatment. Use of a TKI regimen can lower the blood CML biomarker to levels imperceptible by current detection methods. For patients in "molecular remission," however, uncertainties remain regarding whether they will relapse or if treatment should be discontinued.

8 Feb 2016

FedMed gains access to Trovagene's Precision Cancer Monitoring tests and service

Trovagene, Inc., a developer of cell-free molecular diagnostics, announced today that it has entered into an agreement with FedMed, Inc. establishing health benefit access to Trovagene's full line of Precision Cancer Monitoring (PCM) tests and services.

1 Feb 2016

Rice scientists develop new tool to analyze thermal behaviors of DNA and RNA strands

Rice University scientists have developed a tool to speed the design of molecular diagnostics that depend on the specific recognition of pathogen DNA and RNA.

20 Jan 2016

Biocept introduces blood-based test for detection, monitoring of prostate cancer and breast cancer

Biocept, Inc., a molecular diagnostics company commercializing and developing biomarkers to improve the detection and treatment of cancer, announces the launch of the CLIA-validated androgen receptor expression assay using a patient's blood for the detection and monitoring of late-stage prostate cancer and a certain form of breast cancer.

7 Jan 2016

Biocept agrees $15 million common stock purchase deal with Aspire

Biocept, Inc., a molecular diagnostics company commercializing and developing blood-based liquid biopsies to improve the detection, monitoring and treatment of cancer, announces a $15 million common stock purchase agreement with Aspire Capital Fund, LLC, a Chicago-based institutional investor.

22 Dec 2015

Roche announces availability of cobas HBVassay for use on cobas 4800 System

Roche announced today the commercial availability of the cobas HBVassay for use on the cobas 4800 System in countries accepting the CE mark. This new molecular diagnostic assay expands the available virology menu on the cobas 4800 System, improving system efficiency and providing testing flexibility that allows physicians to assess a patient's response to antiviral therapy.

22 Dec 2015

Roche's cobas HIV-1 viral load test approved by FDA for use on cobas 6800 and cobas 8800 Systems

Roche announced today that it has received FDA approval for the cobas HIV-1 viral load test by the United States Food and Drug Administration for use on the cobas 6800 and cobas 8800 Systems. This HIV-1 viral load test is part of the next generation of Roche viral load tests, which clinicians use to manage the disease and treatment of patients infected with HIV-1.

21 Dec 2015

New study finds a reason for ethnic disparity in CF diagnoses

Cystic fibrosis (CF) occurs less frequently in nonwhites than in whites, and nonwhites tend to be diagnosed at a later age. This late diagnosis often comes only once they have become symptomatic, rather than through newborn screening programs or molecular diagnostic testing.

16 Dec 2015

Can Nanostructured Microelectrodes be Used to Analyze Biomarkers? An Interview with Dr Shana Kelley

Electrochemical methods are appealing because simple and inexpensive instrumentation can be used to make highly sensitive measurements. However, it has been quite difficult to realize clinically-relevant levels of sensitivity using electrochemistry in highly complex, real-world samples.

From Pittcon 15 Dec 2015

Roka Bioscience reports revenue of $1.5 million for third quarter 2015

Roka Bioscience, Inc., a molecular diagnostics company focused on providing advanced testing solutions for the detection of foodborne pathogens, today reported its financial results for the quarter and nine months ended September 30, 2015.

12 Nov 2015

Biocept receives European patent covering antibody usage in capture of rare cells

Biocept, Inc., a molecular diagnostics company commercializing and developing liquid biopsies to improve the diagnosis and treatment of cancer, announces that the European Patent Office has awarded the patent, "DEVICES AND METHODS OF CELL CAPTURE AND ANALYSIS," as announced in the European Bulletin dated November 11, 2015.

11 Nov 2015