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Automated Sample Preparation for Next Generation Sequencing Cancer Diagnostics

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43CA165372-01A1
Agency Tracking Number: R43CA165372
Amount: $240,201.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCI
Solicitation Number: PA12-088
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
615 Davis Dr., Suite 800 PO Box 14025
United States
DUNS: 140695474
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 287-9010
Business Contact
Phone: (919) 287-9010
Research Institution

DESCRIPTION (provided by applicant): As more diverse genetic links are established with cancer, the utility of one-gene-one-test diagnostics is diminished. In addition, biopsies are mixed populations of tumor and normal tissue, requiring deconvolution oftumor and non-tumor genoptypes to accurately understand disease etiology and inform treatment decisions. The next generation of cancer diagnostics must therefore achieve two goals: 1) identify genetic variation in a high number of cancer-associated genes and 2) do so in a sample containing a mixed cellular population. Deep sequencing, using the so-called next generation sequencing (NGS) platforms represents a powerful and unique approach to address these challenges. Various capture methods exist, to isolatespecific regions of the genome for sequencing on NGS platforms. Tumor and nontumor genotypes can then be discerned through bioinformatic analysis of the resulting sequencing data. To better enable deep sequencing of tumor biopsies, Advanced Liquid Logic (ALL) will apply its proprietary digital microfluidic liquid handling technology to automate the diagnostic cancer panel assay developed by Foundation Medicine. The resulting prototype system will automate the complex upstream sample preparation system required for NGS analysis of DNA extracted from crude tumor biopsies. ALL will develop a digital microfluidic cartridge capable of DNA purification/concentration, library preparation and targeted enrichment of the cancer-associated genes included in Foundation's panel. By processing these samples in sub-microliter volumes, the ALL platform will also enable analysis of very small biopsy samples, reducing DNA input requirements by 100-1000 fold. In addition to the reliability and labor savings associated with automation, ALL's platform offers cost-effectiveness for non- PCR based sequence capture methods ahead of NGS. PUBLIC HEALTH RELEVANCE PUBLIC HEALTH RELEVANCE: As high throughput DNA sequencing is beginning to move into clinical applications, thearduous sample preparation that is required is likely to become a significant bottleneck. A microfluidic system which automates these processes within an inexpensive cartridge will be developed.

* Information listed above is at the time of submission. *

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