Notice of Intent - Sole Source to PEPperPRINT GmbH

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source follow-on award to the PEPperPRINT GmbH for continuing existing validation studies. The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service. FDA aims to provide tools to enable the development of assays that can provide unambiguous diagnosis of recent vs. past ZIKV infection through peptide-specific differentiation of IgM or IgG responses. These specific peptides will also help distinguishing ZIKV from its closely related viruses. The scope of the existing work is to continue ongoing validation studies which was started in 2016 under contract number 1U01FD006279. Peptides obtained by preliminary screening of full viral proteomes in research project were more numerous than expected due to underestimation of cross-reactivity. Due to the restriction imposed by the available funds, only partial count of the peptides obtained in the discovery screening were selected for the validation studies. In 2019, a first validation step study was conducted to continue the studies of the remainder of the peptides already identified in the original screening stage. Under this requirement, FDA is requesting to complete the final validation of about the remainder of the peptides. PEPperPRINT GmbH has previously conducted the validation studies for this requirement under the previous FDA contract. This is continuation of the same research project and so the work will be continued by the same company. The specimens used in the study were characterized for IgM/IgG antibodies against the virus under study by FDA cleared/ authorized assays as a first choice. This requirement aims to perform comparative proteome-wide epitope mapping analyses of ZIKV and other related viruses’ specific epitopes with single amino acid resolution. This will be a firm fixed price award.