P00001 accession 64 gene plasmid assay, plasmaselect; modify and supplement distribution of clinical reports and clarify file format types. P00001. The contractor shall provide enhanced analysis of…

This contract is a delivery order issued by the Department of Veterans Affairs Veterans Health Administration to Personal Genome Diagnostics Inc., a for-profit company that specializes in genomic and molecular diagnostic testing services. Under the contract, Personal Genome Diagnostics will provide enhanced analysis of clinical and specimen-derived data on all patients seen at VA network hospitals with a cancer diagnosis. This includes targeted DNA sequencing, whole exome sequencing, and RNA sequencing of cancer specimens to identify mutations and provide clinicians with an understanding of their significance. The contract has a firm fixed price of $349,600.00 and a completion date of December 6, 2017. No set-aside designation is mentioned.

P00001 accession 64 gene plasmid assay, plasmaselect; modify and supplement distribution of clinical reports and clarify file format types. P00001. The contractor shall provide enhanced analysis of clinical and specimen-derived data on all patients seen at VA network hospitals who have a cancer diagnosis. The contractor shall furnish a robust, scalable, dynamic, secure, innovative solutions of analyzing samples obtained during regular clinical care such as tissues from biopsy - using new genomic assay technology. The clia vendor shall provide emerging technologies to improve oncology care for all patients within the VA healthcare system. The contractor shall provide targeted sequencing of DNA fragments known to harbor mutations in cancer specimens (commonly referred to as a mutation panel). The number of DNA segments sequenced varies by the laboratory and assay performed. Mutations in the DNA can either be inferred against a laboratory `reference sequence or can be determined by sequencing of patient germ-line DNA obtained from adjacent normal tissue or peripheral blood. The contractors shall provide sequencing of the whole exome of cancer specimens, with mutations identified by comparison against a laboratory `reference sequence or germ-line DNA as described above. The contracotr shall provide sequencing of the cancer specimen RNA or `transcriptome . This strategy can be combined with either targeted or whole exome DNA sequencing. Products of the testing returned to the VA include all sequence data including raw test data (fast-Q, BAM, read quality files and variant call files) and a report of important mutations and their significance to be returned to the medical record. Mutations found in the tumor sample will be annotated so that clinicians can gain an understanding of their meaning. The laboratory shall specify how this annotation will be performed and in particular, what knowledge base will be used to generate the annotations. The contractor shall maintains an up-to-date knowledge base and must be able to update annotations of a patient report upon request. The contractor shall at all times maintain a secure environment and practice covering all protected health information (PHI).