From The Stage

CLIA Requirements for Gene and Cell Therapy Programs

Posted by / / Cell Therapy, Gene Therapy, Regulatory Considerations

It's a common misconception that all aspects of cell & gene therapy research and development are excluded from CLIA oversight. We take a closer look at testing and when CLIA requirements apply.

Novel Gene Therapy Technique Creates a Breakthrough in Sickle Cell Anemia Treatment

Posted by / / BioAgilytix Insight, Gene Therapy

Innovations in gene therapy solutions are being made every day, improving treatments and creating cures for many previously untreatable genetic diseases. In fact, According to a recent report on global trends in gene therapy, the number of gene therapy products in development doubled between 2012 and 2015. The exciting news is that, based on a recent study within the scientific community, sickle cell disease may soon be treatable with gene therapy. It is estimated that 50 million people worldwide carry the genetic mutation for sickle cell disease. This debilitating disease…

Plasma Biomarkers: the Key to Early Alzheimer’s Diagnoses

Posted by / / BioAgilytix Insight, Biomarkers

In 2016, 5.4 million Americans were living with Alzheimer’s disease (AD), and a large majority of those people are over the age of 65. AD can often be difficult to distinguish from other types of dementia, which makes it hard for physicians to diagnose confidently even though it is is the most common type of dementia, accounting for 50-70 percent of total patients. The predicated rise in AD occurrence, in correlation with the rapidly aging population in the United States, is forcing the scientific and medical communities to take a…

Immuno-oncology: Advancing Therapeutic Options for Treating Human Cancers

Posted by / / BioAgilytix Insight, Immuno-oncology

The clinical landscape for cancer is currently undergoing an exciting shift. Treatment based around generic chemotherapies may be taking a back seat to a host of new, targeted therapies as scientists and doctors are beginning to leverage patients’ own immune systems to eliminate cancer cells – and finding success. While the treatment of cancer by immunological tools can be traced back to the early 1900s, recent advancements in assay methods and technologies are finally bringing new levels of immune-based curative cancer treatments, and possibly even the eradication of some cancer…