M2Gen, Moffitt to serve as Central Laboratory and Biorepository for The National MDS Study

Moffitt Cancer Center and M2Gen® have been awarded a contract from the National Institutes of Health's National Heart, Lung, and Blood Institute (NHLBI) to serve as the Central Laboratory and Biorepository for The National Myelodysplastic Syndromes Natural History Study (The National MDS Study). MDS represents a group of blood disorders that affect the bone marrow where blood cells are made. This disease commonly progresses over time to serious or fatal anemia and sometimes transforms into acute leukemia. The mission of this seven-year observation study is to build a national resource to better understand MDS and improve the diagnosis and clinical management of affected individuals.

A cohort of 2,000 adults with MDS and up to 500 age-matched participants who are not diagnosed with MDS will take part in the study. Biospecimens will be collected on patients at least twice a year throughout the course of the study, and these biospecimens will be shipped to Moffitt/M2Gen for processing and storage. In collaboration with the National Cancer Institute clinical study programs, over 150 sites around the nation are expected to participate in this study. The $7.3 million project at Moffitt/M2Gen will be overseen by principal investigator Pearlie Epling-Burnette, Ph.D., Pharm.D., senior member of the Malignant Hematology and Immunology Programs at Moffitt.

"Our job is to ensure high quality tissue collection and storage," said Epling-Burnette. "This is a project that will advance MDS research and translate into new treatment options for patients."

As the number of patients with MDS grows, so do questions related to its exact cause. People diagnosed with MDS are more often men than women and over the age of 60 years at the time of diagnosis in the United States. Also, scientists are unsure what triggers the disease to become more aggressive and transform to acute leukemia. "In the first year of the project, our team will perform a pilot study to address some critical scientific problems that are important for establishing a high quality biorepository for this disease type," said Epling-Burnette. The first task of the Central Laboratory and Biorepository is to provide information to The National MDS Study protocol development team on sample collection procedures.

"Together, Moffitt and M2Gen offer the scientific and technical expertise, facilities and equipment to acquire and store biospecimens on a large scale," said Alan F. List, president and CEO of Moffitt. The operation of the Central Laboratory and Biorepository will be modeled after Moffitt's Total Cancer Care® protocol. Launched in 2006, the protocol provides a standard system for tracking patient molecular, clinical and epidemiological data and follows the patient throughout his or her lifetime. The Total Cancer Care model also is used for the Oncology Research Information Exchange Network (ORIEN). ORIEN partners have access to one of the world's largest clinically annotated cancer tissue repositories and data from more than 100,000 patients who have consented to the donation of their tissue for research. Total Cancer Care and ORIEN are managed by M2Gen, Moffitt's wholly owned, for-profit, informatics solution subsidiary.