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Posts tagged: validation

Everist Genomics Announces External Validation Of OncoDefender™-CRC Test For Predicting Recurrence Risk For Stage I And II Colorectal Cancer Pat

January 22, 2011
Everist Genomics, a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, announced the positive results of the first external validation study of its OncoDefender-CRC colorectal cancer recurrence test. The study is being conducted by Mayo Validation Support Services, and is being coordinated with ...

Sequenom CMM Commences Pivotal Clinical Validation Study For Its SensiGene Trisomy 21 Laboratory Developed Test

December 28, 2010
Sequenom, Inc. (Nasdaq: SQNM) announced that the company's wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of ...

Sequenom CMM authorizes SensiGene T21 LDT clinical validation study

December 23, 2010
Sequenom, Inc. today announced that the company's wholly-owned reference laboratory, the Sequenom Center for Molecular Medicine (Sequenom CMM), has authorized commencement of a pivotal clinical validation study. This validation study is designed to evaluate the clinical performance of the SensiGene T21 Laboratory Developed Test (LDT) for the detection of an ...

Agendia Publishes Compelling First Independent Validation Study Of Colon Cancer Recurrence Test “ColoPrint” In Journal Of Clinical Oncology

December 16, 2010
Agendia, a world leader in molecular cancer diagnostics, announced that together with principal investigators from Spain, the UK, and the Netherlands, it has published the first independent validation study of its colon cancer recurrence test "ColoPrint" in the Journal of Clinical Oncology. The authors conclude that ColoPrint significantly improves prognostic ...

Segasist Technologies Receives Funding From The Health Technology Exchange (HTX) Towards Support Of Clinical Validation Of Its Prostate MRI Software

November 27, 2010
Segasist Technologies, a Canadian software company developing contouring productivity tools for medical imaging, has announced the receipt of funding from The Health Technology Exchange (HTX) towards support of clinical validation of its software, to be conducted at the Lawson Health Research Institute and London Health Sciences Centre (London, Ontario). Experts ...

Segasist Technologies receives HTX funding for clinical validation of prostate MRI software

November 26, 2010
Segasist Technologies, a Canadian software company developing contouring productivity tools for medical imaging, has today announced the receipt of funding from The Health Technology Exchange (HTX) towards support of clinical validation of its software, to be conducted at the Lawson Health Research Institute and London Health Sciences Centre (London, Ontario). ...

Reports claiming ALS caused by head trauma lacks scientific validation

November 19, 2010
A recent study1 suggesting that amyotrophic lateral sclerosis (ALS) may be attributed to "repetitive head trauma experienced in collision sports" lacks scientific epidemiological evidence to support this claim. In a review of the 12-patient study, several experts specializing in motor neuron diseases challenge the findings as entirely pathological and without ...

Reports claiming ALS caused by head trauma lacks scientific validation

November 19, 2010
A recent study (1) suggesting that amyotrophic lateral sclerosis (ALS) may be attributed to "repetitive head trauma experienced in collision sports" lacks scientific epidemiological evidence to support this claim. In a review of the 12-patient study, several experts specializing in motor neuron diseases challenge the findings as entirely pathological and ...

Reports claiming ALS caused by head trauma lacks scientific validation

November 19, 2010
(Wiley-Blackwell) A recent study suggesting that amyotrophic lateral sclerosis (ALS) may be attributed to "repetitive head trauma experienced in collision sports" lacks scientific epidemiological evidence to support this claim. In a review of the 12-patient study, several experts specializing in motor neuron diseases challenge the findings as entirely pathological and ...

Validation Study Of A Web-based Assessment Of Functional Recovery After Radical Prostatectomy

November 4, 2010
In the journal Health and Quality of Life Outcomes, Dr. Andrew Vickers and colleagues at Memorial Sloan Kettering Cancer Center describe a web-based survey for patient-reported outcomes after radical prostatectomy (RP) for prostate cancer (CaP). The benefit of a web-based approach would be to obtain more unbiased and ...

Molecular Detection Inc. Awarded $244,500 Federal Grant To Support US Validation Trial For Its Detect-Ready™ MRSA Screening Panel

November 4, 2010
Molecular Detection Inc. (MDI), a company developing Detect-Ready™ tests designed to increase the speed and accuracy of infectious disease diagnosis, announced that it has been awarded a $244,500 federal Therapeutic Discovery Project grant. The grant is intended to support the US clinical development program for MDI's Detect-Ready panel that ...

Former FDA Inspectors Train Medical Device, Pharmaceutical Companies How to Comply with Latest FDA Expectations for Validation and Part 11

October 29, 2010
WASHINGTON, Oct. 29 /- EduQuest has trained hundreds of FDA inspectors; now it trains thousands of those being inspected by the Agency. A global team of FDA compliance experts, EduQuest is presenting the "FDA Auditing of Computerized Systems and Part 11" training course for quality managers and regulatory ...