A Medical Device Daily
Clinical Research Information eXchange (CRIX; Bethesda, Maryland), the organization dedicated to information sharing in clinical research, reported that it has entered into a memorandum of agreement (MOA) with the FDA and the National Cancer Institute (NCI). This MOA will establish a public-private partnership to pilot the use of CRIX as a not-for-profit organization to manage and continue development of the FIREBIRD application for both government and industry use.
Initially developed by the NCI, FIREBIRD (Federal Investigator Registry of Biomedical Information Research Data) is an application designed to enable sponsors of clinical trials, including the NCI, and the FDA, to manage clinical investigator information as required for documentation on FDA form 1572, in a fully secure, electronic environment. The pilot project to develop and implement additional requirements for FIREBIRD will move site initiation and investigator registration away from a paper-based process and closer to a fully electronic process, as well as create a common registry of investigators for 1572 submission and regulatory review.
In other agreements/contracts:
• DR Systems (San Diego) makers of the Unity RIS/PACS, reported four new contracts with healthcare facilities, totaling about $2.19 million. The four new facilities with which DR has contracts are: Western Missouri Medical Center (Warrensburg, Missouri); Northern Maine Medical Center (Fort Kent, Maine); Riverview Hospital Association (Wisconsin Rapids, Wisconsin); and Coastal Cancer Care and Diagnostic Center (Pismo Beach, California).
The largest contract was for about $746,000, with the smallest contract at about $240,000. This range reflects the scalable nature of DR Systems' RIS/PACS.
DR Systems is an independent provider of medical imaging and information systems for diagnostic imaging centers and hospitals.
• Molina Healthcare (Long Beach, California) reported that its wholly owned subsidiary, Molina Healthcare of Florida has been awarded a Medicaid managed care contract by the Florida Agency for Health Care Administration (AHCA). The term of the contract will commence on December 1, 2008, at which time Molina Healthcare of Florida will begin its initial enrollment of Florida NetPASS Medicaid members, with the full transition of NetPASS members expected to be completed in the 1Q09. The contract award by AHCA follows its licensing of Molina Healthcare of Florida to operate as a health maintenance organization in Dade County.
"The Florida contract award represents a significant opportunity in an important new state for Molina Healthcare. We look forward to assisting our new members in Dade County in accessing high quality health care benefits," said J. Mario Molina, MD, president/CEO of Molina.
• CaridianBCT (Lakewood, Colorado) a provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, signed a multi-year agreement with the American Red Cross (ARC; Washington) to continue the use of its automated blood collection technology in ARC blood centers throughout the U.S.
For more than 50 years, the American Red Cross has been a primary supplier of life-saving blood and blood products in the U.S. Through its Biomedical Services division, the American Red Cross collects and distributes nearly half of the U.S. blood supply, collecting over 6 million units of blood from nearly 4 million blood donors annually.
The increasing demand for blood components and testing standards, as well as the decreasing donor availability, has heightened the need for blood centers to maximize the ability of every eligible donor to donate the specific blood components required to meet patient needs a critical factor in ensuring a sufficient, safe blood supply. The Trima Accel system enables blood centers to collect multiple component combinations of leukoreduced, ready-to-store red cells including double red cells platelets and plasma, from a single donor, in a single donation.
• ProGenTech Limited (Emeryville, California) a life sciences & diagnostics company has signed a licensing agreement with Human Genetic Signatures, (HGS; Sydney, Australia) life science company to gain access to key hospital-acquired infection targets, payment terms were not disclosed.
HGS will develop assays for MRSA, MSSA, VRE and C. difficile which will then be further integrated into the ProGenTech Entura platforms. It is anticipated that manual assays for these initial targets will be taken to the FDA during 2009 followed by fully integrated and automated versions of the assays in 2010. Launching these assays will mark ProGenTech's initial foray into the molecular diagnostics market.
This new relationship with HGS marks the formal launch of ProGenTech's Applied Sciences business which will take products and solutions into the Molecular Diagnostics, Forensics and Immunoassay market segments.
• MicroStrategy (Mclean, Virginia) a provider of business intelligence software, reported that the Premier Healthcare Alliance (San Diego) plans to expand its deployment of MicroStrategy software to enhance its performance improvement tools for hospitals.
Premier plans to augment its suite of hospital performance tools and has selected MicroStrategy to provide detailed analytical and reporting capabilities. The more than 2,000 members of the alliance use the Premier suite of analytic tools for greater insights into physician performance, clinical performance, financial performance, and compliance.
Premier currently uses the MicroStrategy Business Intelligence Platform to offer its member hospitals comparative healthcare information services to help drive performance improvements.