DNA Purification Method for HPV Testing

Period of Performance: 05/10/2004 - 11/09/2004


Phase 1 SBIR

Recipient Firm

Gentra Systems, Inc.
Minneapolis, MN 55441
Principal Investigator


DESCRIPTION (provided by applicant): Molecular-based diagnostic testing has been rapidly and widely adopted in clinical laboratories throughout the world for the diagnosis, detection and treatment of patients with a wide variety of diseases. Molecular-based testing has had an especially significant impact on the diagnosis of infectious diseases, including Human Papillomavirus (HPV). The demand for molecular-based testing for HPV has rapidly grown to over 6 million samples per year and is growing at a rate of approximately 45% annually. The increased demand for HPV testing has created an urgent need for more efficient and effective methods of DNA purification from exfoliated cervical samples. These samples are unique and especially challenging because of the inherently variable nature of the sample and the non-cellular sample components that interfere with nucleic acid purification. Unfortunately, most current methods for purification of DNA from cervical samples rely on toxic reagents and are extremely time consuming. An alternative approach is capture hybridization but this approach is costly, difficult to automate, and limited by its inability to distinguish individual HPV types. In summary, current purification methods do not meet the demands of clinical laboratories that require safe, reliable, affordable, high-throughput methods for the purification of HPV. Thus, the specific aims of this Phase I grant are: 1. Establish the feasibility of a non-toxic manual method for the purification of HPV from exfoliated cervical samples. 2. Establish the feasibility of methods for the normalization of HPV samples prior to analysis. 3. Establish the feasibility of an automated method for HPV purification. Phase II will focus on the long-term objective of development and optimization of the automated method in anticipation of commercial availability. Accomplishing these specific aims will revolutionize HPV testing by increasing the reliability, sensitivity, and throughput of HPV diagnostic testing and provide clinicians with the opportunity to better detect, diagnose and treat patients with HPV. Thesaurus terms: DNA purification, automation, HPV, human papillomavirus, cervical cancer, STD.