Chronix Biomedical filed a provisional United States patent application jointly with Hemispherx Biopharma Inc. on a blood test for Chronic Fatigue Syndrome (CFS). Patients with CFS exhibit a wide range of disabling symptoms including the inability to overcome fatigue by rest, swollen lymph nodes and cognitive deficiencies. CFS is estimated to affect approximately 4 million Americans, according to the Centers for Disease Control and Prevention (CDC). The disorder has a negative economic impact in the United States estimated at more than $9 billion annually.
The Chronix experimental approach analyzes fragments of DNA often released into the bloodstream during the process of apoptosis or programmed cell death. Chronix is using its proprietary technology and advanced DNA sequencing platforms to measure alterations in specific regions of the chromosome, which can be detected as distinctive “signatures” in cell-free blood-borne DNA. By focusing on these signatures, Chronix’s technology can detect the presence of disease-damaged cells in simple blood samples without needing to biopsy diseased cells or tissues.
“Our technology, based on DNA released into the bloodstream by dying and damaged cells, taps into the dynamic information provided by the genomic alterations unique to each diseased cell. We capture what is happening to the DNA very early in and throughout the disease process, in real time, and patient by patient. That’s how our approach differs from other tests that focus on static genomic data or protein biomarkers,” said Dr. Howard Urnovitz, CEO at Chronix. "The patient-unique signatures captured by the Chronix technology may prove useful as a companion diagnostic – a test that is used to help guide treatment decisions – and to provide information about the disease process to help pharmaceutical companies select the most efficacious drug candidates.
Use of the Chronix diagnostic technology in CFS will be evaluated in a study being planned by Chronix and Hemispherx. Dr. William Carter, Hemispherx CEO, commented, “It is with great enthusiasm that we will be conducting studies aimed at validating the utility of the Chronix technology to identify how different individuals can respond to Hemispherx’s experimental drug Ampligen.”
The Chronix Biomedical blood test for Chronic Fatigue Syndrome is experimental in nature and has not been evaluated by any regulatory agency. It is currently limited to investigational use.