Intelligent Medical Devices (IMDx) has signed a multi-year agreement with Abbott Laboratories (ABT), under which IMDx will design, develop, regulatory clear and manufacture assays for the FDA cleared, m2000 instrument system to be distributed worldwide.
IMDx tests are designed utilizing IMDx’s bioinformatics process which ensures high performing products that are optimized and in silico verified.
The tests will include identification of infectious organisms like 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 US for the determination of viral load for Epstein-Barr virus (EBV) and BK Virus (BKV).
IMDx chairman and CEO Alice Jacobs said they are 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," Jacobs said.
Abbott molecular diagnostics business head Stafford Kelly said 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 marketed assays, that are available on a single automated instrument system.