Lucira Health, Inc. — Department of Health and Human Services STTR Phase I: NIAID

Description

DESCRIPTION provided by applicant 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 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 doctorandapos 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 a swab processing unit for rapid min DNA extraction from clinical samples with minimal operator requirements diagnostic assay development for rapid min and multiplexed Ct detection and strain typing on an inexpensive platform and 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 $ million for scale up and clinical trials will be required to have this product in market by Q 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 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