Intelligent Medical Devices, Inc. (IMDx) has announced that they have signed a multi-year agreement with Abbott whereby IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott Molecular FDA cleared, m2000 instrument system to be distributed worldwide. Financial terms have not been disclosed.
IMDx tests are incorporating important and evolving clinical needs. The tests are designed utilizing IMDx's proprietary bioinformatics process which ensures high performing products that are optimized and in silico verified. Tests will include identification of the following infectious organisms, Clostridium difficile, Vancomycin-Resistance Enterococci (VRE), Group B Streptococci (GBS), Influenza A/Influenza B (INFA/B), and Herpes Simplex Virus 1 and 2 (HSV 1/2).
In addition, two additional tests will be commercialized for use outside the United States for the determination of viral load for Epstein-Barr virus (EBV) and BK Virus (BKV).
"We are extremely pleased to capture the synergies between IMDx and Abbott and to be able to offer these important tests to patients globally. The test areas under this agreement directly address a major unmet need in the clinical lab: high quality tests that are FDA cleared if for US sales. Early identification of these pathogens can help improve patient healthcare, shorten treatments, and reduce expense," says Alice Jacobs, MD, Chairman & CEO of IMDx.
"This agreement, which demonstrates Abbott Molecular's commitment to menu expansion on the m2000 system, will allow customers to gain access to a broad menu of FDA and internationally marketed assays, that are available on a single automated instrument system," says Stafford O'Kelly, head of Abbott's molecular diagnostics business.