Lucira Health, Inc. — Department of Health and Human Services SBIR Phase II: NIAID

Description

Abstract Chlamydia trachomatis Ct is the most common cause of bacterial sexually transmitted diseases STD with million annual cases worldwide and million U S cases in Most female and male infections are asymptomatic facilitating unchecked transmission that can result in pelvic inflammatory disease infertility chronic pelvic pain and life threatening ectopic pregnancy Ct is also a risk factor for invasive squamous cell carcinoma of the cervix and a complicating factor in HIV infection Patients are often treated without a definitive diagnosis which can lead to inappropriate antibiotic use and possibly drug resistance The main obstacle to stemming Ct infections is the lack of a point of care POC diagnostic to increase early detection to reduce infection rates and sequelae Current Ct diagnostics rely on commercial nucleic acid amplification tests NAATs that vary in sensitivity and specificity with a general lack of concordant results for the same sample type NAATs are expensive require equipment and highly trained operators take a day to days for results and can result in loss to follow up and delay in treatment Thus current NAATs are not suitable POC diagnostics Our team of Dr Deborah Dean an expert on Ct STDs and POC development and Diassess a startup company with proprietary technology for POC diagnostics showed in Phase I that we can extract Ct nucleic acids from endocervical swabs in min with no instruments in a prototype Sample Preparation Module have an instrument free multiplexed Detection Module for min colorimetric detection of Ct nucleic acids have validated assays to detect all Ct reference strains differentiate lymphogranuloma venereum LGV from non LGV strains and detect human DNA and have demonstrated assay results consistent with standard NAAT results on remnant endocervical patient samples In Phase II we will advance on Phase I results Aim Using the expanding aggregate of reference and clinical Ct genome sequences refine our primers replacing failed primers as needed and ensure that our refined Ct primer amplification assays detect Ct reference and diverse Ct clinical strains without cross reactivity with sexually transmitted pathogens and common vaginal cervical species Aim Optimize sample preparation chemistry amplification assay design and colorimetric chemistry for vaginal urethral and endocervical swabs and interfering substances Aim Evaluate sensitivity and specificity of our fully integrated system the combined Sample Preparation Module with Detection Module compared to commercial NAATs By the end of Phase II we will be poised to manufacture and use our rapid andlt min inexpensive user friendly instrument free sensitive and specific Ct POC test for clinical trials in the U S to obtain FDA regulatory clearance via the k pathway Our overall goal is to deploy our Ct POC diagnostic for use in doctorandapos s offices small to large city and rural clinics teen and STD clinics emergency rooms other testing sites and resource constrained settings around the world Project Narrative This project will impact public health validating a rapid inexpensive user friendly sensitive and specific Chlamydia Ct point of care POC diagnostic that can be used in doctorandapos 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