Insilicos, a Seattle-based biomedical software company, is partnering with the University of Washington to market a cloud-based version of the university’s Rosetta protein and molecular modeling software.
The plan, which the agency made public on Jan. 19, detailed a number of draft guidances FDA intends to put out this year; but it's the items that it declined to address, like the development of a new Class IIb device category, that could be the most significant.
The patent follows on one the company received last year for the Erenna platform itself, and comes as it begins efforts to develop the assay as a clinical diagnostic that it hopes to submit for US Food and Drug Administration approval within the next two years.
A number of prominent proteomics-based diagnostics developers were recipients of the grant and tax credit awards, which are being provided by the IRS through the Patient Protection and Affordable Care Act's Qualifying Therapeutic Discovery Project Program.
Building on the results of a 38-patient study published in July, the company hopes to develop its PreClue cardiovascular disease biomarker panel as a clinical diagnostic for either screening or treatment-planning purposes.