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Rapid Point-of-Care Assay for detecting High Risk Human Papillomavirus

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44CA128858-01
Agency Tracking Number: CA128858
Amount: $99,999.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2007
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
IQUUM, INC. 700 Nickerson Rd
MARLBOROUGH, MA 01752
United States
DUNS: 125606017
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MARTIN ZILLMANN
 (617) 588-5314
 MZILLMANN@VARIAGENICS.COM
Business Contact
 ROBERT CASPAR
Phone: () -
Email: shuqi@iquum.com
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat(tm)) platform for the detection and genotyping of high risk Human Papillomavirus (HPV) from cervic
al swab samples. The Liat HPV Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the HPV test at a hospital, clinic or physician's office in 1 hour. By enabling effective and sensitive single visit HPV testing, we exp
ect that the Liat assay will allow clinicians to identify more women at risk for cervical cancer and provide immediate and effective intervention, thereby significantly lowering the incidence of cervical cancer. The Liat HPV Assay overcomes the limitations
of current HPV tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease prevention due to significant patient loss to follow-up and lack of penet
ration into resource-poor regions in the US and abroad. In Phase I of this Fast Track project, we intend to prove the feasibility of developing a 1 hour sample-to- result Liat HPV Assay by developing melting-point PCR assays for HPV-16 and HPV-18 and Liat-
based extraction for HPV nucleic acids from HPV-containing cervical cell lines. In Phase II, we propose to expand the assay developed in Phase I to include the majority of high risk HPV types that are found in cervical cancer, develop Liat sample preparati
on for cervical samples, as well as integrate all assay components, including internal controls, into a single Liat tube for multiplex HPV detection. We further intend to characterize and validate the Liat HPV Assay in a pre-clinical study. At the conclusi
on of this Fast Track project, we will be prepared to submit the Liat HPV assay for FDA- approved clinical study. The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health.

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

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