The primary objectives of Grace Laboratories include:the discovery of disease-associated biomarkers, and the development of diagnostic tests for the commercial use of unique products in the in-vitro diagnostic (IVD) market segments of Life Science Research, Diagnostics and Laboratory Services, in accordance with the dynamics of the industry and the highest standards of excellence and integrity.
Grace Laboratories follows Clinical Laboratory Improvement Amendments (CLIA) standards. GRACE Antibody Test has a CE mark. The test can be sold for research use only in the USA. Grace Laboratory will consider strategic alliances with Original Equipment Manufacturer's and reference laboratories, to access resources for clinical validation of IVD products, U.S. Food and Drug Administration clearance.
The company intends to license its intellectual property concerning brain biomarkers and technology to strategic partners possessing OEM technologies. It further intends to outsource the manufacturing of IVD products. The company is also pursuing partnerships with marketing and distribution organizations experienced in selling test kits to laboratories, institutions and hospitals for research purposes only.