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A Rapid Point-of-care Diagnostic for C. trachomatis STDs

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2012 / SBIR
Agency Tracking Number:
R44AI084206
Solicitation Year:
2012
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-123
Small Business Information
NetBio, Inc.
830 Winter Street Waltham, MA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2012
Title: A Rapid Point-of-care Diagnostic for C. trachomatis STDs
Agency: HHS
Contract: 2R44AI084206-03A1
Award Amount: $3,000,000.00
 

Abstract:

DESCRIPTION (provided by applicant): Improved diagnosis of Chlamydia trachomatis (Ct) infections represents a critical unmet medical need. Ct is the most common cause of bacterial sexually transmitted diseases (STD) worldwide, and the Centers for Disease Control and Prevention estimate that there are 2.8 million US cases annually. Currently, 40% of women with untreated infection will develop pelvic inflammatory disease (PID), 20% of whom will become infertile, 18% will experience debilitating, chronic pelvic pain, and 9% will have a life-threatenig ectopic pregnancy. If an infected pregnant woman is not treated, her baby has a 50% chance of developing conjunctivitis and a 20% chance of pneumonia in the first six months of life. Ct is also a risk factor for invasive squamous-cell carcinoma of the cervix and a complicating factor in HIV-1 infection and transmission. In males, the clinical presentation includes proctitis, genital ulcer and/or inguinal lymphadenopathy. The main obstacle to stemming this epidemicis the lack of an inexpensive nucleic acid-based point-of-care (POC) diagnostic for screening. Current chlamydial diagnostics are primarily based on nucleic acid amplification tests (NAAT) that lack concordance across the different NAATs, vary in sensitivity (although specificity is high), are expensive, require technical expertise, take days for results, and cannot be performed at the POC. They are also unable to differentiate between invasive lymphogranuloma venereum (LGV) versus non-invasive strains, the former of which require weeks of antibiotic therapy for eradication. Our overall SBIR goal is to develop a rapid, cost-effective, sensitive and specific Ct POC diagnostic system to increase early detection, inform appropriate treatment, reduce the rateof infections, and thereby reduce sequelae. In SBIR Phase I, we developed an initial microfluidic NAAT and demonstrated that its sensitivity and specificity are superior to those of a commercial NAAT. In SBIR Phase II, we propose to: 1) Optimize our assaybased on information gained by whole genome sequencing clinical Ct strains; 2) incorporate all assay processes in an easy-to operate breadboard instrument; and 3) do a head-to-head comparison of the optimized system against two commercially available assays. Given the genomic expertise of Dr. Tim Read and the chlamydial STD expertise of Dr. Dean, and the molecular biological and microfluidic expertise of Dr. Selden, the application provides a unique collaborative opportunity to finally obtain a rapid nucleic-acid based POC diagnostic for C. trachomatis. PUBLIC HEALTH RELEVANCE: Chlamydia trachomatis is the leading bacterial cause of sexually transmitted diseases in the US. Many of these infections are asymptomatic and go undetected, which leads toincreased transmission and the sequelae of pelvic inflammatory disease, infertility and ectopic pregnancy. Current diagnostics require extensive technical expertise, are expensive and take days for results, leading to loss of follow up. NetBio is developing an easy to use, cost effective diagnostic that detects C. trachomatis within one hour at the point-of-care.

Principal Investigator:

Richard F. Selden
781-938-6013
richard.selden@netbio.com

Business Contact:

Susan S. O'keefe
781-916-9052
susan.okeefe@netbio.com
Small Business Information at Submission:

NETWORK BIOSYSTEMS, INC.
830 Winter Street Waltham, MA -

EIN/Tax ID: 104352570
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No