News Release

Moffitt, M2Gen tapped to coordinate central laboratory, biorepository services for MDS

The joint venture with the National Heart, Lung and Blood Institute will support the National MDS Natural History Study

Business Announcement

H. Lee Moffitt Cancer Center & Research Institute

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.

This project is funded in whole with federal funds from the NHLBI, NIH and the Department of Health and Human Services, under contract number HHSN2682014000031. At M2Gen, this represents the first federally funded contract for biorepository services and demonstrates the high standards set forth by the institution. Moffitt/M2Gen's experience is aligned with the NHLBI goal of providing quality research material and data through centralized national registries.


About Moffitt Cancer Center

Located in Tampa, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt's excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the "Best Hospitals" for cancer since 1999. With more than 4,500 employees, Moffitt has an economic impact on Florida of nearly $1.6 billion. For more information, visit, and follow the Moffitt momentum on Facebook, Twitter and YouTube.

About M2Gen

M2Gen is Moffitt Cancer Center's wholly owned, for-profit, informatics solution subsidiary advancing personalized medicine by using high quality tissue, clinical data and molecular technology to accelerate the discovery and delivery of personalized medicine. Using a rapid learning approach, the goal of M2Gen is to accelerate the science of precision medicine by creating evidence and knowledge-based solutions that identify a patient's susceptibility to disease, predict how the patient will respond to a particular drug, and match patients to the best therapies for an optimal treatment outcome. M2Gen, along with Moffitt and 17 hospitals in a Consortium Network, has created a large, cancer-focused, biorepository linked to clinical and molecular data. For more information, visit

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