Diagnostics Pre-Clinical Services Program

Support the development and introduction of new IVD products to detect, identify, and characterize potential agents of bioterrorism, antimicrobial-resistant pathogens, emerging and re-emerging infectious pathogens, as well as infectious pathogens prevalent in resource-limited countries remain a high public health priority. The suite of services shall encompass those activities commonly associated with the development of IVD tests for infectious disease required for FDA 510(k) clearance, Premarket Approval (PMA), and Emergency Use Authorization (EUA) or pre-EUA authorization.

Task areas under the contract include:
Task Area A- Product Development Processes and Documentation
Task Area B- Recombinant Proteins and Monoclonal Antibodies
Task Area C- Biochemical Reagents: Nucleic Acids and Oligonucleotides
Task Area D- Clinical Specimens and Bacterial Isolates
Task Area E- Next-Gen Sequencing, Immunoassays, Nucleic Acid Amplification Assays
Task Area F- Pre-Pilot and Pilot-Scale GMP Manufacturing Services