The success of this test encourages larger studies of its predictive value and possible ability to identify patients who may respond to Ampligen®
Hemispherx Biopharma, Inc., (developer of the drug Ampligen) presented new data from a study involving an investigational blood test for Chronic Fatigue Syndrome (CFS) at the IACFS/ME Conference held September 22-25, in Ottawa.
The test is based on Chronix Biomedical, Inc.'s technology, which analyzes DNA released into the bloodstream by dying and damaged cells and has the potential to detect genomic alterations unique to diseased cells.
Previously, Chronix utilized Next Generation Sequencing (NGS) to generate sufficient DNA sequences to provide the statistical power to identify alterations in blood DNA from patients with breast and prostate cancer vs. normal healthy controls.
The aim of this recent CFS study was to find signature DNA sequences from patients with CFS compared to healthy controls:
• With respect to their diagnostic predictive value,
• As well as to potentially provide new insight into CFS biology.
DNA extracted from serum samples of CFS subjects and normal healthy controls was sequenced and compared to the human genome.
A total of about 10,000 high quality sequence reads were generated from each serum sample - and four genes were identified by Multivariate Regression that separated CFS patients from the normal control group with a c-value of 0.95.
These results support additional studies with a larger CFS cohort using more powerful Massively Parallel Sequencing platforms with the aim of reduction to validated clinical assays:
• For the diagnosis and evaluation of CFS,
• And to explore whether the technology can be used to identify how different persons with CFS will respond to Hemispherx's experimental drug Ampligen.
Chronix and Hemispherx previously announced (March 3, 2011) the filing of a joint patent application for a blood test for CFS based on this technology. Chronix and Hemispherx are currently planning to validate the ability of the approach to identify how different persons with CFS can respond to Hemispherx's experimental drug Ampligen.
Note: The blood test for CFS is still experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.
Source: Hemispherx Biopharma press release, Sep 26, 2011