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Low Cost, Rapid Molecular Diagnostic for Chlamydia and Gonorrhea at the Point-of-Care

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI136161-02
Agency Tracking Number: R44AI136161
Amount: $1,983,767.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-04-21
Award End Date (Contract End Date): 2022-03-31
Small Business Information
1363 CHESTNUT AVE
Annapolis, MD 21403-4905
United States
DUNS: 079691224
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ANDREA PAIS
 (352) 642-2391
 andrea@novelmicrodevices.com
Business Contact
 ANDREA PAIS
Phone: (352) 642-2391
Email: andrea@novelmicrodevices.com
Research Institution
N/A
Abstract

PROJECT ABSTRACT:
Building on the successes of our Phase 1 SBIR project, we propose to refine and productize our
sample-to-answer CT/NG NAAT and to validate the analytical and clinical performance of the
assay in the intended use setting in Phase 2 of this SBIR project. ​Chlamydia trachomatis (CT)
and ​Neisseria gonorrhoeae ​(NG) infections are the number one and two most commonly
reported bacterial sexually transmitted infections (STI) respectively, with an estimated 2.86
million new CT cases and 820,000 new NG cases in the US each year, and associated costs
exceeding $1 Billion. Both infections are curable with antibiotics, however no CLIA waved, rapid,
accurate diagnostic test is available to inform clinical treatment decisions during the patient visit.
Untreated infections lead to serious sequelae including pelvic inflammatory disease (PID) and
its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic pain.
Furthermore, loss to follow-up is a significant problem with STI patients. Therefore, timely
diagnosis using accurate diagnostics and early treatment is imperative. Rapid, immunoassay
based point-of-care (POC) tests for CT/NG fail to diagnose more than 50% of Chlamydia
positive cases. Nucleic Acid Amplification Tests (NAATs) are the current gold standard for
diagnosing CT/NG due to their high sensitivity and specificity. As such ​​there is great need for
an effective POC diagnostic test for CT/NG.
In Aim 1 ​we will integrate assay controls and optimize our multiplex assay for CT/NG. In Aim 2,
we will develop the “Beta” Novel Dx device that will meet the FDA and CLIA waiver guidance
requirements.
In Aim3,
​we will conduct more in-depth analytical studies for sensitivity, inclusivity,
exclusivity, cross-reactivity of our optimized sample to answer assay. In Aim 4, we will place the
Novel Dx system in clinical settings and conduct end-user performance and usability
evaluations. The outcome of Phase II will provide sufficient data as well as a refined system
design to inform a decision regarding multicenter clinical trials and product launch.PUBLIC HEALTH RELEVANCE STATEMENT
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are easily cured with
antibiotics, however since most cases are asymptomatic, they often go undiagnosed and
untreated. Untreated infections lead to serious sequelae including pelvic inflammatory disease
(PID) and its associated complications, such as ectopic pregnancy, infertility, and chronic pelvic
pain. Timely diagnosis using accurate point-of-care diagnostics and early treatment is
necessary. We propose to develop a rapid, automated, multiplex nucleic acid amplification test
for CT/NG to enable immediate testing and treatment of infected individuals in a single visit.

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

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