New Colon Cancer Gene Licensed Exclusively to Myriad Genetics
Wednesday April 14, 6:30 am ET
Myriad's Predictive Medicine Sample Flow Continues to Grow
SALT LAKE CITY, April 14 /PRNewswire-FirstCall/ -- Myriad Genetics, Inc. (Nasdaq: MYGN - News), announced today that it has licensed exclusive rights in the United States to detect mutations in an important new colon cancer gene. Myriad believes that the new colon cancer gene, known as Mut Y Homolog (MYH), will provide improved sensitivity and predictive utility to the Company's COLARIS® product line for detecting all major forms of hereditary colon cancer. The Company expects to introduce the enhanced test during the next quarter as an integral component of its COLARIS range of products, and also as a stand-alone test.
"We are pleased to extend our tradition of providing highly accurate and sensitive predictive medicine testing products," said Gregory Critchfield, M.D., President of Myriad Genetic Laboratories, Inc. "Continual evaluation, enhancement and refinement of our products helps assure that patients and their physicians receive the most informative results possible for use in healthcare decision making."
Myriad's COLARIS and COLARIS AP® products are increasingly penetrating the existing market for colon cancer prediction and are being readied to expand into the broader potential hereditary colorectal cancer market through addition of MYH gene mutation detection. Concurrently, Myriad's BRACAnalysis® line of products and MELARIS® continue to perform well. The Company now receives more than 500 specimens for testing each week, which compares with approximately 450 samples per week at the end of last quarter, a quarter-to-quarter increase of over 10%.
MYH is a DNA repair gene that corrects DNA basepair mismatch errors in the genetic code prior to replication. If the MYH gene is mutated and non-functional, the DNA repairs are not made and colon cancer can result. The MYH gene has been found to be significantly involved in colon cancer, both in cases where there is a clear family history of the disease and in cases without any sign of a hereditary cause. This fact was demonstrated in a study of 111 British subjects published in the journal Lancet. The study participants each had more than 10 polyps, no family history of colon cancer in their parents or their children, and were negative for mutations in the APC colon cancer gene that causes familial adenomatous polyposis (FAP). The study found that a surprisingly high total of 25 individuals (23%) were positive for mutations in the MYH gene.
A second study, published recently in the New England Journal of Medicine and led by Oliver Sieber, BSc. and Lara Lipton, MB, BS, at the London Research Institute, also examined patients who had no known gene abnormality but had multiple colorectal polyps. The study found that about 1/3 of people who had more than 15 polyps but fewer than 100 had two mutated copies of the MYH gene. Of the people with more than 100 polyps, 7.5% had two mutated copies of the MYH gene. While further work is required to fully elucidate the implications for those with a mutation in just one MYH gene, some researchers have suggested that it may increase the risk of colon cancer in such individuals as well.
About Hereditary Colorectal Cancer Syndromes
According to the American Cancer Society, approximately 147,000 people in the United States will be diagnosed with colorectal cancer in 2004. It is the second leading cause of cancer death in this country. Approximately 20% of these individuals will have a family history of two or more relatives with colon cancer. Most of these patients will have one of the three major colon cancer syndromes, HNPCC, FAP or attenuated FAP. HNPCC is diagnosed in approximately 6,000 individuals each year and is characterized by early onset of colorectal cancer and by uterine cancer in women. HNPCC is most often caused by a mutation in either the MLH1 or MSH2 gene, which can be detected with the COLARIS test. FAP is characterized by the presence of hundreds to thousands of colon polyps that typically begin to appear at age 16. Without preventive surgery, all individuals with FAP get colon cancer, usually before age 40. The primary cause of both attenuated FAP and FAP is a mutation in the APC gene, which the COLARIS AP test is designed to detect. Mutations in the MYH gene are associated with a high risk of colorectal cancer and a clinical disorder similar to that seen with attenuated FAP. Investigators have estimated that mutations in the MYH gene are likely to account for a higher proportion of colorectal cancer cases than those due to mutations in the APC gene.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the role of mutations in the MYH cancer gene in increasing risk of colon cancer; Myriad's belief that the MYH cancer gene will provide significantly enhanced sensitivity and predictive utility to Myriad's tests in detecting all major forms of hereditary colon cancer; the introduction of an enhanced test during the next quarter as an integral component of Myriad's COLARIS® range of products and as a stand-alone test; the ability of COLARIS and COLARIS AP® to expand the potential market in colon cancer prediction and diagnosis; the continued and expected volume of weekly sample flows and the potential for record predictive medicine product sales for the third fiscal quarter of 2004;. These forward looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are identified in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2003. All information in this press release is as of April 14, 2004, and Myriad undertakes no duty to update this information unless required by law. |
