Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, said today it will join the Institut Pasteur to launch a research collaboration aimed at fighting the worldwide epidemic of tuberculosis.
The public-private research collaboration will be funded through a grant to the Institut Pasteur from the Bill & Melinda Gates Foundation. The amount of the funding was not disclosed.
The partners will carry out a proof-of-concept study to evaluate patients with latent and active TB infections who are affiliated with the South African Tuberculosis Vaccine Initiative (SATVI) clinical study sites.
The study is intended to field-test Myriad RBM's TruCulture® system as a point-of-care blood collection and immune response monitoring method, as well as to stratify patients with active and latent tuberculosis. Once blood samples are collected, Myriad RBM and the Institut Pasteur will seek to discover protein biomarkers important in regulating the immune system response, using Myriad RBM's MAP (Multi-Analyte Profiling) platform.
MAP technology is designed to offer preclinical and clinical researchers broad, cost-effective analyses of multiple proteins from a single, small sample volume. Myriad RBM is applying MAP technology to support efforts to develop companion diagnostics in neuropsychiatry, nephrology, and immunology.
“Prior studies support the use of the TruCulture system in settings with limited resources, and may help us improve the diagnosis of TB and accelerate the development of new drugs and vaccines to treat the disease,” Matthew Albert, M.D., Ph.D., co-coordinator of Milieu Interieur and director of the Immunology Department at Institut Pasteur, said in a statement.
Unlike current laboratory-based methods, TruCulture can deployed at the site of collection, thus avoiding variability from shipping and complex processing as well as the expense of a cell culture facility and staff.
Last year, Myriad RBM and Institute Pasteur published a study detailing their use of TruCulture for characterizing individual immune responses of 25 healthy people to medically relevant stimuli. The results, reported in the journal Immunity, showed that TruCulture stimulations were reproducible, with close correspondence in repeated tests from the same subject.
Twenty-seven immune system stimulants were incorporated into TruCulture to determine how healthy subjects' immune systems would respond to bacteria, fungi, viruses, therapeutics and vaccines. Immune responses were measured using protein biomarkers from Myriad RBM's MAP platform.
The study was an initial analysis of data from the landmark Milieu Interieur Project, a population-based study designed to characterize the immune phenotypes of 1,000 healthy subjects. The Project was supported by the French National Ministry of Research, with coordination of six’ research institutions’ activities by the Project’s host institution, Institut Pasteur.
The analysis revealed a unique pattern of immune system responses for each stimulant tested that can be further studied and used to define genetic and/or environmental causes of natural or disease-induced variations in the human immune system. For example, two of the first 25 subjects evaluated were unable to produce the cytokine interleukin one alpha (IL-1α)—a protein associated with immune and inflammatory response—in response to any of the stimuli evaluated.
The partners reason that such insights may help explain susceptibility to a specific disease or predict response to immune-modulating therapies.
“Tuberculosis is a challenging disease. We need better technology to diagnose patients and assess individual immune response to treatment,” Dr. Albert stated.
Added Ralph McDade, president of Myriad RBM: “If we are successful, TruCulture may prove to be useful in a multitude of field-based, point-of-care applications, leading to improved patient care.”
“We believe that TruCulture can help to stratify TB patients with latent versus active disease. This will lead to the optimization of treatments and provide better support for vaccine clinical trials,” McDade added.
According to World Health Organization figures released in October, 9 million people fell ill to TB in 2013, during which 1.5 million died from the disease. TB is second only to HIV/AIDS as the greatest global disease caused by a single infectious agent.