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Molecular Biometrics Announces Results of Parkinson's Disease Research and Receipt of Grant From Michael J. Fox Foundation to Advance Diagnostic Technology
Date:8/5/2008

New research demonstrates proof-of-concept for diagnosing Parkinson's

disease using non-invasive, biospectroscopy technology Michael J. Fox Foundation awards grant to Molecular Biometrics for further

development of Parkinson's diagnostic

CHESTER, N.J. and MONTREAL, Aug. 5 /PRNewswire/ -- A study published in the June issue of the peer-reviewed journal, Biomarkers in Medicine, demonstrated proof-of-concept for the use of a minimally-invasive technology being developed by Molecular Biometrics, LLC, to diagnose Parkinson's disease (PD). In the study, researchers used spectroscopy to develop a metabolic profile (or chemical signatures) of biological markers for PD. There is currently no definitive laboratory diagnostic for Parkinson's disease.

The company also announced receipt of an award from The Michael J. Fox Foundation for Parkinson's Research supporting further development of its technology platform to validate its PD diagnostic methodology.

"The lack of an objective biomarker to aid diagnosis and therapeutics development is one of the single greatest challenges facing the Parkinson's research field," said Katie Hood, CEO of The Michael J. Fox Foundation. "We are enthusiastic about helping to keep Molecular Biometrics' novel metabolomic diagnostic technology moving forward toward validation and clinical testing."

Researchers at Molecular Biometrics, Lady Davis Institute (LDI), Sir Mortimer B. Davis - Jewish General Hospital and McGill University have shown that, using biospectroscopy methods to create a specific biomarker profile, they can distinguish idiopathic Parkinson's disease from normal aging and other neurodegenerative conditions. Diagnosis of PD is currently based solely on a patient's medical history and neurological examination, making Parkinson's difficult to diagnose, particularly during early stages of the disease.

"We created a biomarker profile, using biospectroscopy techniques, to delineate a chemical signature in blood that identifies patients with Parkinson's disease," said Hyman M. Schipper, MD, PhD, FRCPC, lead author of the study and member of the Faculty of Medicine, Department of Neurology and Neurosurgery, and Department of Medicine, McGill University, and member of the Attending Staff in Neurology at Sir Mortimer B. Davis - Jewish General Hospital, in Montreal, Canada. "This proof-of-concept gives us great hope that biospectroscopy will offer a new approach to the early diagnosis of Parkinson's disease and other neurodegenerative disorders." Dr Schipper is a noted expert in brain aging and neurodegeneration, and a Founding Scientist and Medical Director (Neurosciences) at Molecular Biometrics.

In the study, fifty-two patients, 20 with mild or moderate stages of Parkinson's disease and 32 age-matched control subjects were recruited at the Jewish General Hospital. Whole blood samples were analyzed using near- infrared (NIR) spectroscopy and Raman spectroscopy (RS) methods which have previously been used to create metabolomic profiles (chemical signatures) of human biofluids, including serum and whole blood.

Both NIR and RS methods were applied to measure the degree of oxidative stress (OS) present in each sample. OS has been considered to be a potential biomarker for Parkinson's disease. However, to date, chemical markers have not proven sufficiently robust to serve as an accurate or reliable biomarker of the disease. OS is caused by a chemical imbalance that can damage critical components of a cell, including proteins, lipids and DNA. OS is known to be involved in many diseases, including PD and Alzheimer's disease. The data from this study showed that the two independent biospectroscopy measurement techniques yielded similar and consistent results. In differentiating Parkinson's disease patients from the control group, RS achieved a sensitivity of 74% and specificity of 72%, with eight false positives and four false negatives. NIR achieved a sensitivity of 74% and specificity of 76%, with four false positives and five false negatives.

"We are greatly encouraged by these results and will continue our research and development efforts to further explore the application of our proprietary technology in the development of an accurate, minimally invasive and cost- effective diagnostic tool for Parkinson's disease," added James T. Posillico, PhD, President and Chief Executive Officer, Molecular Biometrics.

"Spectroscopy of human plasma for diagnosis of idiopathic Parkinson disease," was published in Biomarkers in Medicine (June 2008, Vol. 2, No. 3, Pages 229-238).

Molecular Biometrics was one of six industry research teams to receive a total of $2.7 million in funding granted under The Michael J. Fox Foundation's Therapeutics Development Initiative (TDI) program. TDI is the cornerstone of the Foundation's venture philanthropy efforts to help push promising candidate therapeutics forward in industry pipelines by allowing the Foundation to share the risk of product development.

"We are honored to be a grant recipient of The Michael J. Fox Foundation, and are excited to have our technology recognized for its potential to positively impact the future of PD diagnosis and treatment," said Posillico.

About Parkinson's Disease

Parkinson's disease is a chronic, degenerative neurological disorder that affects one in 100 people over age 60. This degenerative disorder of the central nervous system often affects motor skills and speech, as well as other functions, and is characterized by muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement. Parkinson's disease belongs to a group of conditions called movement disorders. While the average age at onset is 60, disease onset starts by age 40 in an estimated five to 10 percent of patients, and people as young as 30 can also be affected. It is estimated that at least one million people in the United States, and six million worldwide, have Parkinson's disease.

About Metabolomics

Metabolomics is a complex scientific process that identifies and measures individual signals from many molecular compounds produced by cellular metabolism which, when evaluated as a whole, represent unique biomarkers of biologic function in health and disease.

Molecular Biometrics uses near infrared (NIR) biospectroscopy in its metabolomic applications. NIR is a robust platform that rapidly measures the vibrational energy absorbed by molecular functional groups, creating a profile of molecules that are descriptive of cellular function.

The spectral signatures are further analyzed by proprietary bioinformatics and chemometrics that result in the creation of a novel "metabolomic profile" or "fingerprint" that can be used to distinguish systematically between the often subtle differences that separate normal physiology from the onset or progression of disease, or an individual's response to therapeutic intervention. Metabolomics is commonly used in pharmaceutical research, molecular diagnostics and food and agrichemical industries.

About The Michael J. Fox Foundation

Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within the coming decade through an aggressively funded research agenda. The Foundation has funded approximately $126 million in research to date. For more information, please visit http://www.michaeljfox.org.

About Molecular Biometrics

Molecular Biometrics, LLC, is applying novel metabolomic technologies to develop accurate, non-invasive clinical tools for use in personalized medicine to evaluate normal biologic function in health and in disease, and for drug discovery and development. The company's proprietary technology is being applied in reproductive health and IVF, neurodegenerative disease (e.g., Alzheimer's disease and Parkinson's disease), maternal fetal medicine, pulmonary metabolism and edema, and lactate metabolism. Molecular Biometrics is privately held and headquartered in Chester, NJ, with research and development facilities in New Haven, CT, and Montreal, Quebec. For more information, please visit http://www.molecularbiometrics.com.


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