PARIS, France and SALT LAKE CITY, Utah, March 20, 2014 – Institut Pasteur and Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc., today announced they have published an initial data analysis from the landmark Milieu Interieur Project in the journal Immunity, which provided new insights into the healthy human immune response. The Milieu Interieur project is a population-based study supported by the French National Ministry of Research and coordinated by the Institut Pasteur, Paris that will characterize the immune phenotypes of 1,000 healthy subjects. The results could lead to the development of novel diagnostics and companion diagnostics.
In the paper titled, "Functional Analysis using Standardized Whole Blood Stimulation Systems Defines the Boundaries of a Healthy Immune Response to Complex Stimuli," the authors describe the use of Myriad RBM's TruCulture® technology, a proprietary blood collection and culturing system, to characterize individual immune responses of 25 healthy people to medically relevant stimuli. Unlike the current laboratory-based methods, TruCulture is deployed at the site of collection and therefore avoids variability from shipping and complex processing as well as the expense of a cell culture facility and staff. The results in the Immunity paper show that TruCulture stimulations are reproducible, with close correspondence in repeated tests from the same subject.
"The immune system is highly complex and is responsible for maintaining healthy conditions in the body. Understanding responses to stimuli is critical to understanding the origins and progression of infection, autoimmunity and cancer," said Matthew Albert, co-coordinator of Milieu Interieur and director of the Immunology Department at Institut Pasteur. "As a clinical pathologist and immunologist, I believe it is important to have immune monitoring tools that reliably measure inflammatory responses and TruCulture performed exceedingly well. Our findings will lead to additional studies and possibly new diagnostic tests for inflammatory, autoimmune, oncological, and infectious diseases, as well as companion diagnostics for therapeutics."
In this study, the 27 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 (Multi-Analyte Profiling) platform. Analysis of the data reveal 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, the researchers reported that 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. These types of insights may help explain susceptibility to a specific disease or predict response to immune-modulating therapies.
"The TruCulture system reliably profiles the complexity of the immune system in a simple blood collection and culture tube. We believe it will usher in a new era for monitoring the immune response," said Ralph McDade, president of Myriad RBM. "We are actively pursuing several research collaborations to develop TruCulture as a novel diagnostic in cancer immunotherapy, autoimmune disorders and vaccine response."
About Institut Pasteur and the Milieu Interieur Project
The Institut Pasteur is a private, non-profit foundation. Its mission is to help prevent and treat diseases, mainly those of infectious origin, through research, teaching, and public health initiatives. The Milieu Interieur project is a population-based study supported by the French National Ministry of Research and coordinated by the Institut Pasteur, Paris. The goal of Milieu Interieur is to characterize the immune phenotypes of 1,000 healthy subjects in response to 32 complex immune stimulants. Responses to these stimuli in TruCulture are being assessed using advanced cellular, nucleic acid, proteomic and metabolic assay technologies. For more information visit: http://www.milieuinterieur.fr/en
About Myriad RBM
Myriad RBM is a wholly owned subsidiary of Myriad Genetics, Inc. Myriad RBM's biomarker discovery platform provides clinical researchers and healthcare providers with reproducible, quantitative, multiplexed data for hundreds of proteins to advance drug development and patient care. The Company's proprietary Multi Analyte Profiling (MAP) technology offers preclinical and clinical researchers with broad, cost-effective analyses of multiple proteins from a single, small sample volume. MAP technology also supports Myriad RBM's drive to develop companion diagnostics in areas of unmet medical need such as neuropsychiatry, nephrology, and immunology. More information about Myriad RBM can be found at http://www.myriadrbm.com.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Milieu Interieur project characterizing the immune phenotypes of 1,000 healthy subjects; the results of the Milieu Interieur project potentially leading to the development of novel diagnostics and companion diagnostics; the current findings leading to additional studies and possibly new diagnostic tests for inflammatory, autoimmune, oncological, and infectious diseases, as well as companion diagnostics for therapeutics; insights such as those gained in the current study helping to explain susceptibility to a specific disease or to predict response to immune-modulating therapies; the TruCulture system ushering in a new era for monitoring the immune response; developing TruCulture as a novel diagnostic in cancer immunotherapy, autoimmune disorders and vaccine response; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are management's present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to increased competition and the development of new competing tests and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.