Rapid Point-of-Care Diagnostic Test for Chlamydia

Iquum, Inc., Marlborough MA

Investigators

Abstract

[unreadable] DESCRIPTION (provided by applicant): The goal of this project is to develop a rapid, highly sensitive, and easy-to-use polymerase chain reaction (PCR)-based detection system, which can be used in a physician's office, for detecting Chlamydia trachomatis (CT) infection using IQuum's innovative Lab-in-a-tube (LiatTM) technology. Chlamydia is the most frequently reported sexually transmitted disease in the United States, the leading cause of tubal infertility in women, and an important cause of infertility in men. It is estimated that each year there are over 4 million new Chlamydia cases in the United States. The estimated annual cost of Chlamydia in the United States exceeded $2.4 billion annually. A point-of-care nucleic acid test is needed to promptly diagnose of Chlamydia while the patient is still present in physician's office in order to assist physician to prescribe the appropriate treatment. In Phase I, we propose to develop novel specific TaqMan probes which can differentiate CT from other bacteria or proteobacteria, and develop a rapid real-time PCR for CT detection within 15 minutes on our proprietary lab-in-a-tube technology platform. In addition, we will develop assays for nucleic acid isolation from urine and disposables to facilitate the sample preparation. The proposed approach will allow us to perform CT detection from urine sample to result in less than 30 minutes without the need of centrifugation or hand-on sample preparation. In Phase II, we plan to integrate the sample preparation and detection into one using Liat tube technology and make this assay deployable in the point-of-care setting. We will also plan to multiplex the detections of CT and Neisseria gonorrhoeae (NG), the second most frequently reported sexually transmitted disease. [unreadable] [unreadable]