The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the availability of a Duchenne muscular dystrophy therapeutic area user guide (TAUG-DMD v1.0) for public review. The review period for the TAUG-DMD v1.0 began on May 8, 2017, and runs through July 6, 2017. Qualified researchers and clinicians are encouraged to review TAUG-DMD v1.0 and offer feedback.Continue reading
Author Archive: AZBio
ASU engineer working to develop disposable point-of-care sensor
The project aims to develop a disposable, point-of-care biosensor for rapid diagnosis and health monitoring, supported by a four-year, $1.8 million Smart and Connected Health award from the National Science Foundation.Continue reading
VisionGate Hires Prominent Pathologist as Medical Director
Former Massachusetts General Hospital’s Dr. David Wilbur To Oversee VisionGate’s CLIA laboratory. VisionGate’s ground-breaking technology can help eradicate not only the world’s deadliest disease – lung cancer — but other cancers as well.
Independent Data Monitoring Committee Recommends Continuation of Cancer Prevention Pharmaceuticals’ Phase 3 Trial for Familial Adenomatous Polyposis Patients
CPP-1X/sulindac aims to prevent disease progression
Brain State Technologies: Successful clinical trial shows reduction of insomnia symptoms
HIRREM neurotechnology better than placebo for insomnia, and improvement of autonomic cardiovascular regulation
UA Research Says H. Pylori Needs Much Closer Attention
If the bacterium involved in a host of digestive maladies isn’t eradicated after treatment, that could indicate a resistance to antibiotics — and that’s worrisome.Continue reading
Castle Biosciences Presents Three New Clinical Studies at ASCO
Castle Biosciences Presents Three New Clinical Studies at ASCO 2017 Highlighting the Accuracy and Performance of the DecisionDx-Melanoma Gene Expression Profile Test for Cutaneous Melanoma | Prospective, multicenter study confirms prognostic accuracy and performance | Newly expanded cohort shows promise in prognosis of Stage III melanoma
FDA Approves VENTANA ALK (D5F3) Assay as a companion diagnostic for ZYKADIA.
On June 1, 2017, Roche (SIX: RO, ROG; OTCQX:RHHBY) announced US Food and Drug Administration (FDA) approval of the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA ALK (D5F3) Assay is the only immunohistochemistry (IHC) test approved by the FDA as a companion diagnostic for ZYKADIA.Continue reading