The need to develop sensitive, specific, and more easily available point-of-care technologies for diagnosing STIs is critical. Many countries, including the US, have seen a sharp increase in the incidence of STIs over the past half-decade, and especially since 2020. Many cases go undiagnosed and untreated, and 30% of patients may never get treatment after testing positive. Some of these STIs have the potential to cause serious health problems, including infertility, especially if not diagnosed and treated early. Stigma, privacy, and confidentiality issues make STIs optimal areas for POC tests at healthcare facilities, as they can reduce loss to follow-up, increase patient and partner treatment rates, and avoid the use of unnecessary antibiotic treatment. The company has developed a Molecular Point of Care platform, the AmplifiDxTM DX-1000, which is capable of rapid, molecular testing using direct swabs as the sample type. The system has five optical channels, allowing detection of up to 4 infectious targets plus an internal control. The DX-1000 is differentiated and well-suited for the infectious disease testing market. The chemistry is multiplexed and sensitive, yet simple, allowing for a miniaturized product that will be attractive in the point-of-care space. The workflow is easy - one-step, swab to answer - and does not require complex mixing of reagents or handling of multiple stages of the process. Lab- quality results will be delivers in as little as 30 minutes for COVID-19. 20 minutes are possible for DNA parameters as the number of assay steps can be less. The sleek cartridge and instrument are designed for low- cost manufacturing. AmplifiDx is poised to submit a first Emergency Use Authorization (EUA) to the FDA for a COVID-19 diagnostic, which is the basis for the proposed assay for STIs and relevant resistance markers. We propose the development of an assay which will detect Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG), as well as mutations associated with antibiotic resistance or susceptibility in NG. We also propose the development of a urine collection device that fits easily in to the existing workflow, to give doctors the choice of another sample type. This assay, which will be used with urogenital swabs or urine samples on the DX-1000 device and cartridge, will provide quick, actionable diagnosis for CT and NG at point of care, as well as guiding treatment decisions and promoting antibiotic stewardship by identifying antibiotic-related mutations.
Public Health Relevance Statement: NARRATIVE AmplifiDx will develop an assay for point-of-care diagnosis of sexually transmitted infections (STIs) - Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) - and detection of antibiotic resistant or susceptible genes in NG that will provide treatment recommendation and a urine collection device. The assay will run on the DX-1000 device, currently under advanced development for COVID-19 detection, and will utilize the simple, single step "˜swab to answer' workflow that is already developed and expand the use to urine samples which are commonly used in STI clinics, allowing physicians to receive diagnoses and prescribe treatments in the span of a single visit.
Project Terms: Acceleration; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Antibiotics; Biological Assay; Assay; Bioassay; Biologic Assays; Ceftriaxone; Cefatriaxone; Chemistry; Chlamydia trachomatis; C trachomatis; C. trachomatis; Rickettsia trachomae; Communicable Diseases; Infectious Disease Pathway; Infectious Diseases; Infectious Disorder; Diagnosis; DNA; Deoxyribonucleic Acid; Health; Health care facility; Health Facilities; Healthcare Facility; care facilities; Incidence; Infertility; Cannot achieve a pregnancy; Difficulty conceiving; fertility cessation; fertility loss; infertile; Marketing; Mutation; Genetic Alteration; Genetic Change; Genetic defect; genome mutation; Neisseria gonorrhoeae; Gonococcus; N gonorrhea; N gonorrhoeae; N. gonorrhea; N. gonorrhoeae; Neisseria gonorrhea; Optics; optical; Patients; Physicians; pressure; Questionnaires; Reagent; Recommendation; Research; Risk; Running; Sexually Transmitted Diseases; Sexually Transmitted Disorder; Sexually Transmitted Infection; Venereal Diseases; Venereal Disorders; Venereal Infections; Surveys; Survey Instrument; Testing; Urine; Genitourinary system; Genitourinary; Urogenital; Urogenital System; Privacy; Resistance to antibiotics; Resistant to antibiotics; antibiotic drug resistance; antibiotic resistant; Antibiotic Resistance; Diagnostic tests; Area; Clinical; Funding; Gravities; Force of Gravity; Point of Care Technology; fluid; liquid; Liquid substance; tool; Antibiotic Therapy; Antibiotic Treatment; bacterial disease treatment; bacterial infectious disease treatment; instrument; Complex; Clinic; System; Country; Visit; Magnetism; magnetic; rapid diagnosis; internal control; validation studies; Devices; Sampling; social stigma; stigma; assay development; miniaturize; miniaturized; Lysis; Cytolysis; Swab; Detection; Collection; Validation; validations; Molecular; Process; follow-up; Active Follow-up; active followup; follow up; followed up; followup; Development; developmental; point of care; Output; Advanced Development; designing; design; Antibiotic susceptibility; resistant; Resistance; Predisposition gene; predisposing gene; susceptibility allele; susceptibility locus; susceptibility variant; Susceptibility Gene; usability; prototype; point-of-care diagnostics; resistance locus; resistant gene; resistance gene; Infrastructure; COVID19; CV-19; CV19; corona virus disease 2019; coronavirus disease 2019; coronavirus disease-19; coronavirus infectious disease-19; COVID-19; RadX.; Radx-; Rapid Acceleration of Diagnostics; RADx; FDA EUA; Food and Drug Administration EUA; Food and Drug Administration Emergency Use Authorization; emergency use authorization; FDA Emergency Use Authorization; COVID19 diagnostic; SARS-CoV-2 diagnostic; coronavirus disease 2019 diagnostic; severe acute respiratory syndrome coronavirus 2 diagnostic; COVID-19 diagnostic; COVID19 detection; SARS-CoV-2 detection; coronavirus disease 2019 detection; detect COVID-19; detect COVID19; detect SARS-CoV-2; detect severe acute respiratory syndrome coronavirus 2; severe acute respiratory syndrome coronavirus 2 detection; COVID-19 detection; isothermal amplification; point-of-care diagnosis; in-vitro diagnostics; detection assay; point of care testing; multiplex assay; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting; diagnostic tool; manufacture; manufacturing cost; fabrication cost
