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VARIAGENICS Announces Licensing Agreements For MTHFR Patents.


Business Editors & Health/Medical Writers

BIOWIRE2K

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 16, 2003

VARIAGENICS, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic.

Antonym: dec.
. (Nasdaq: VGNX), an emerging molecular diagnostics company and leader in pharmacogenomics, today announced that it has granted worldwide licenses to GeneOhm Sciences, Sciona, and Tm Bioscience relating to VARIAGENICS' MTHFR MTHFR Methylenetetrahydrofolate Reductase (gene mutation)  (methylenetetrahydrofolate reductase) patent rights. Under the terms of the agreements, VARIAGENICS has granted the companies worldwide non-exclusive rights to commercialize several test formats to detect polymorphisms within the MTHFR gene for applications including the assessment of thrombo-embolic disease risk. The agreements stipulate that VARIAGENICS retains the rights to the development of pharmacogenomic applications in oncology and other disease areas.

All three companies recognize the value of MTHFR genotyping for preventive medicine preventive medicine, branch of medicine dealing with the prevention of disease and the maintenance of good health practices. Until recently preventive medicine was largely the domain of the U.S.  and for assuring optimal individual patient care, and expect significant growth in individual genetic testing Genetic Testing Definition

A genetic test examines the genetic information contained inside a person's cells, called DNA, to determine if that person has or will develop a certain disease or could pass a disease to his or her offspring.
 within the cardiovascular field. "This license is an important step for us in building a strong molecular diagnostic portfolio and providing key tools for true personalized medicine," said Peter Klemm, Ph.D., President and Chief Executive Officer of GeneOhm Sciences. "We are excited about the prospect of providing patients with low cost, rapid response tests having extremely high specificity in predicting individual risk for predisposition to thrombo-embolic events. Early assessment of risk factors like MTHFR can improve therapy for many patients with deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen. , patients making pre-surgery decisions, and those at risk during pregnancy, assuring optimal patient care."

"The MTHFR gene is one of the core elements of our Nutrigenomic and Genetic Diagnostic panels," said Dr. Anthony Leung, Sciona's Commercial Director. "Research indicates that individuals appreciate knowing their genetic status and its nutritional implications and that they understand the significance of the well-established links between metabolism, disease and wellbeing. We are excited about the potential these panels will have in personalized medicine and expect to see tremendous growth in demand as the potential benefits for preventive health are recognized."

"In developing the Tm Bioscience Tag-It(TM) Mutation Detection kit for common coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  mutations, many of our customers requested the ability to test for the two common mutations in the MTHFR gene as part of the coagulation panel," said Greg Hines, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Tm Bioscience. "This in-licensing agreement, allows us to provide commercial diagnostic laboratories with this tailor-made option within our existing coagulation kit."

The MTHFR patent rights were acquired from McGill University by VARIAGENICS in 1999. Since then, VARIAGENICS and McGill University have actively collaborated in the discovery and development of pharmacogenomic markers related to this gene. A number of research studies associate variations in the MTHFR gene with cardiovascular disease, and the gene is also believed to be involved in central nervous system disorders Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
, osteoporosis, disorders influenced by folic acid metabolism, and cancer. Earlier prediction and/or detection of these diseases are a key focus for medical researchers, pharmaceutical companies, and treating physicians. In June 2000, the U.S. Patent and Trademark Office issued U.S. Patent 6,074,821 titled "cDNA for Human Methylenetetrahydrofolate Reductase" and in April 2001 issued US Patent 6,218,120 titled "Methods for detecting human methylene methylene /meth·y·lene/ (meth?i-len) the bivalent hydrocarbon radical —CH2— or CH2dbond.

meth·yl·ene
n.
 tetrahydrofolate reductase reductase /re·duc·tase/ (-tas) a term used in the names of some of the oxidoreductases, usually specifically those catalyzing reactions important solely for reduction of a metabolite.  allelic al·lele  
n.
One member of a pair or series of genes that occupy a specific position on a specific chromosome.



[German Allel, short for Allelomorph, allelomorph, from English
 variants." Both patents, which were assigned to McGill University, were licensed exclusively to VARIAGENICS under the terms of the original 1999 agreement. These patents cover the identification of MTHFR gene polymorphisms in a sample of DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 from an individual. The polymorphisms covered in these patents include the common polymorphism, C677T, which has been correlated with reduction in protein activity, leading to elevated homocysteine Homocysteine Definition

Homocysteine is a naturally occurring amino acid found in blood plasma. High levels of homocysteine in the blood are believed to increase the chance of heart disease, stroke, Alzheimer's disease, and osteoporosis.
 and increased patient risk. Polymorphism detection can be used to diagnose MTHFR deficiency or to identify an individual possessing an MTHFR allele allele (əlēl`): see genetics.
allele

Any one of two or more alternative forms of a gene that may occur alternatively at a given site on a chromosome.
 variant. The polymorphisms can be associated with cardiovascular disorders, cancer (neuroblastoma Neuroblastoma Definition

Neuroblastoma is a type of cancer that usually originates either in the tissues of the adrenal gland or in the ganglia of the abdomen or in the ganglia of the nervous system.
, colorectal carcinoma), coronary and arterial disorder, osteoporosis, neurological disease (neural tube defects Neural tube defects
A group of birth defects that affect the backbone and sometimes the spinal chord.

Mentioned in: Birth Defects
), and disorders influenced by folic acid metabolism.

About GeneOhm

GeneOhm Sciences uses the flow of electric current through DNA to detect genetic mutations. This proprietary chip-based technology allows clinicians to identify a patient's genetic mutations accurately, sensitively and rapidly with a simple and inexpensive reader. GeneOhm Sciences was formed in 2001 with technology developed over a decade by Professor Jacqueline K. Barton at the California Institute of Technology California Institute of Technology, at Pasadena, Calif.; originally for men, became coeducational in 1970; founded 1891 as Throop Polytechnic Institute; called Throop College of Technology, 1913–20. . The Company believes its platform will become the primary system that clinicians use to focus human genomic information on individual patient care. For more information, please visit the Company's website at www.geneohm.com.

About Sciona

Sciona is the leading genetic diagnostics and pharmacogenomics company in the United Kingdom. Combining a wealth of research, Sciona has developed a range of genomic panels, supported by proprietary algorithms and informatics to give customers specific advice on lifestyle factors such as diet through to clinical areas, e.g. drug use and disease prevention. Sciona has developed a world class expertise in the deployment of genetic profiling to provide personalized wellbeing advice - BodyBenefits(TM). The Company has developed the most sophisticated system for the delivery of personalized wellbeing and medical advice, and is now ready to bring its first products to market in the US and Europe. Sciona is proud to take a lead in this exciting new industry and use the science of tomorrow to enable a real difference to be made in the healthcare arena. For more information, please visit Sciona at www.sciona.com.

About Tm Bioscience

Tm Bioscience is a DNA-based diagnostics company developing and manufacturing a suite of genetic tests. Tm Bioscience's product pipeline includes tests for genetic mutations related to hematology, cystic fibrosis, toxicology and other debilitating de·bil·i·tat·ing
adj.
Causing a loss of strength or energy.


Debilitating
Weakening, or reducing the strength of.

Mentioned in: Stress Reduction
 genetic disorders. Tm Bioscience is an ideal partner for companies, academics or clinical labs with novel gene content who want to capture near term value through the development of marketable tests. Tm Bioscience is located in Toronto, Ontario. The Company has recently launched the Tag-It(TM) Mutation Detection kit, which provides accurate, low cost, high-throughput results for laboratories on common coagulation mutants. Additional information can be found at www.tmbioscience.com.

About VARIAGENICS

VARIAGENICS, INC. develops molecular diagnostic tests by identifying genetic markers associated with response to cancer therapies, with the goal of optimizing patient care. The Company analyzes genetic variation, including single nucleotide polymorphisms (SNPs), haplotypes, loss of heterozygosity Loss of heterozygosity (LOH) in a cell represents the loss of one parent's contribution to part of the cell's genome. LOH can arise via several pathways, including deletion, gene conversion, mitotic recombination and chromosome loss. , and expression levels in normal and tumor cells. VARIAGENICS is developing molecular diagnostic tests through both biopharmaceutical collaborations and its own internal research programs. For more information, please visit the Company's website at www.variagenics.com.

This press release may contain forward-looking statements, including statements regarding the effect of pharmacogenomics on therapeutic outcomes and the delivery of healthcare and the role that the Company will play in the field of pharmacogenomics. Such statements are based on management's current expectations and are subject to certain factors, risks and uncertainties that may cause actual results, events and performance to differ materially from those referred to or implied in such statements. These risks are identified in VARIAGENICS' Annual Report on Form 10-K for the fiscal year ended December 31, 2001. The Company does not intend to update any of the forward-looking statements after the date of this release to conform these statements to actual results or to changes in our expectations, except as required by law.
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Date:Jan 16, 2003
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