SBIR-STTR Award

Detecting Chlamydia (Ct) STIs at the point-of-care (POC) represents a critical unmet medical need. Development of an effective Ct POC diagnostic will result in widespread screening efforts for rapid diagnosis to inform treatment and evaluate treatment efficacy, and for test-of-cure that would not only reduce the acute and chronic morbidity that is directly associated with these infections, but could also provide benefit by reducing potential collateral risks, including HIV-1 infection, cervical cancer, and autoimmune-driven arthritis. Although current diagnostics exist, they remain expensive, are technically challenging, vary in concordance for sensitivity, cannot strain type, take days for results, and ar confined to major clinical or reference laboratories. The overall goal of this Phase I application s to develop a rapid, cheap, user-friendly, sensitive and specific Ct POC diagnostic that can be used in doctor's offices, small to large clinics, teen and STD clinics, emergency rooms, and appropriate resource constrained settings globally. The Aims of Phase I will be met with the complementary expertise, equipment, and facilities of Dr. Deborah Dean and Diassess. During Phase I, the following will be achieved: 1) a swab processing unit for rapid (~10 min) DNA extraction from clinical samples with minimal operator requirements, 2) diagnostic assay development for rapid (~40 min) and multiplexed Ct detection and strain typing on an inexpensive platform, and 3) sensitivity and specificity determination of the system. Upon completion of these objectives, in Phase II the injection molding manufacturing processes will be developed, leading to highly scalable and low cost devices. A larger sample size, including inhibitory samples will also be analyzed. Primers will be developed against other STIs (GC, HPV, and Trichomoniasis) and integrated into the platform. Additionally, samples from other important clinical sites, including the conjunctiva, pharynx, urine, urogenital ulcer, vagina, and rectum will be tested. Additional funds of ~$3 million, for scale up and clinical trials, will be required to have this product in market by Q3 2017.

Public Health Relevance Statement:


Public Health Relevance:
The overall goal of this Phase I application is to develop a rapid, inexpensive, user-friendly, sensitive, and specific Chlamydia (Ct) point-of-care (POC) diagnostic that can be used in doctor's offices, small-to-large clinics, teen and STD clinics, emergency rooms, and elsewhere. Detecting Ct STIs at the POC represents a critical unmet medical need with implications in large-scale screening and early detection. A Ct POC would reduce infection rates, inform appropriate treatment, and reduce unnecessary antibiotic use and ultimately, reduce transmission and sequelae.

Project Terms:
Accident and Emergency department; Acute; Antibiotics; Antibodies; Arthritis; assay development; Autoimmune Process; Bacterial DNA; Bacterial Sexually Transmitted Diseases; base; Bedside Testings; Biological Assay; Care Technology Points; Cervix Uteri; Chemistry; Chlamydia; Chlamydia trachomatis; Chronic; chronic pelvic pain; Clinic; Clinical; clinical research site; Clinical Trials; Communicable Diseases; conjunctiva; Conjunctivitis; cost; Data; design; Detection; Development; Devices; Diagnosis; Diagnostic; DNA; DNA amplification; Drug resistance; Early Diagnosis; efficacy testing; Epidemic; Equipment; experience; Female; follow-up; Funding; Genitourinary system; Goals; HIV-1; Human Papillomavirus; improved; Infection; Infertility; Injection of therapeutic agent; instrument; Ions; Laboratories; Life; Lymphogranuloma Venereum; male; Malignant neoplasm of cervix uteri; manufacturing process; Marketing; Measures; Medical; meetings; Methods; Molds; Morbidity - disease rate; Mothers; Mutate; novel; Nucleic Acid Amplification Tests; Organism; Patients; Pelvic Inflammatory Disease; Pharyngeal structure; Phase; Pneumonia; point of care; point-of-care diagnostics; Procedures; Process; prototype; public health relevance; rapid diagnosis; Rectum; Resources; Risk; Risk Factors; Sample Size; Sampling; scale up; Scheme; screening; Sensitivity and Specificity; Sexually Transmitted Diseases; Squamous cell carcinoma; stem; Swab; System; Teenagers; Temperature; Testing; TimeLine; Training; transmission process; Treatment Efficacy; Treatment Protocols; Trichomonas Infections; Ulcer; Urine; user-friendly; Vagina; validation studies; Visual; Woman

Detecting Chlamydia (Ct) STIs at the point-of-care (POC) represents a critical unmet medical need. Development of an effective Ct POC diagnostic will result in widespread screening efforts for rapid diagnosis to inform treatment and evaluate treatment efficacy, and for test-of-cure that would not only reduce the acute and chronic morbidity that is directly associated with these infections, but could also provide benefit by reducing potential collateral risks, including HIV-1 infection, cervical cancer, and autoimmune-driven arthritis. Although current diagnostics exist, they remain expensive, are technically challenging, vary in concordance for sensitivity, cannot strain type, take days for results, and ar confined to major clinical or reference laboratories. The overall goal of this Phase I application s to develop a rapid, cheap, user-friendly, sensitive and specific Ct POC diagnostic that can be used in doctor's offices, small to large clinics, teen and STD clinics, emergency rooms, and appropriate resource constrained settings globally. The Aims of Phase I will be met with the complementary expertise, equipment, and facilities of Dr. Deborah Dean and Diassess. During Phase I, the following will be achieved: 1) a swab processing unit for rapid (~10 min) DNA extraction from clinical samples with minimal operator requirements, 2) diagnostic assay development for rapid (~40 min) and multiplexed Ct detection and strain typing on an inexpensive platform, and 3) sensitivity and specificity determination of the system. Upon completion of these objectives, in Phase II the injection molding manufacturing processes will be developed, leading to highly scalable and low cost devices. A larger sample size, including inhibitory samples will also be analyzed. Primers will be developed against other STIs (GC, HPV, and Trichomoniasis) and integrated into the platform. Additionally, samples from other important clinical sites, including the conjunctiva, pharynx, urine, urogenital ulcer, vagina, and rectum will be tested. Additional funds of ~$3 million, for scale up and clinical trials, will be required to have this product in market by Q3 2017.

Public Health Relevance Statement:


Public Health Relevance:
The overall goal of this Phase I application is to develop a rapid, inexpensive, user-friendly, sensitive, and specific Chlamydia (Ct) point-of-care (POC) diagnostic that can be used in doctor's offices, small-to-large clinics, teen and STD clinics, emergency rooms, and elsewhere. Detecting Ct STIs at the POC represents a critical unmet medical need with implications in large-scale screening and early detection. A Ct POC would reduce infection rates, inform appropriate treatment, and reduce unnecessary antibiotic use and ultimately, reduce transmission and sequelae.

NIH Spending Category:
Bioengineering; Eye Disease and Disorders of Vision; HIV/AIDS; Infectious Diseases; Sexually Transmitted Diseases/Herpes; Urologic Diseases

Project Terms:
Accident and Emergency department; Acute; amplification detection; Antibiotics; Antibodies; Arthritis; assay development; Autoimmune Process; Bacterial DNA; Bacterial Sexually Transmitted Diseases; base; Bedside Testings; Biological Assay; Care Technology Points; Cervix Uteri; Chemistry; Chlamydia; Chlamydia trachomatis; Chronic; chronic pelvic pain; Clinic; Clinical; clinical research site; Clinical Trials; Communicable Diseases; conjunctiva; Conjunctivitis; cost; Data; design; Detection; Development; Devices; Diagnosis; Diagnostic; diagnostic assay; DNA; DNA amplification; Drug resistance; Early Diagnosis; efficacy testing; Epidemic; Equipment; experience; Female; follow-up; Funding; Genitourinary system; Goals; HIV-1; Human Papillomavirus; improved; Infection; Infertility; Injection of therapeutic agent; instrument; Ions; Laboratories; Life; Lymphogranuloma Venereum; male; Malignant neoplasm of cervix uteri; manufacturing process; Marketing; Measures; Medical; meetings; Methods; Molds; Morbidity - disease rate; Mothers; Mutate; novel; Nucleic Acid Amplification Tests; Organism; Patients; Pelvic Inflammatory Disease; Pharyngeal structure; Phase; Pneumonia; point of care; point-of-care diagnostics; Procedures; Process; prototype; public health relevance; rapid diagnosis; Rectum; Resources; Risk; Risk Factors; Sample Size; Sampling; scale up; Scheme; screening; Sensitivity and Specificity; Sexually Transmitted Diseases; Squamous cell carcinoma; stem; Swab; System; Teenagers; Temperature; Testing; TimeLine; Training; transmission process; Treatment Efficacy; Treatment Protocols; Trichomonas Infections; Ulcer; Urine; user-friendly; Vagina; validation studies; Visual; Woman