CROSSLIFE TECHNOLOGIES INC. — Department of Health and Human Services SBIR Phase I: NIAID

Description

We propose the development of a highly sensitivesimple paper strip molecular nucleic acid blood test that detects parasites causing malaria at the point of careThe final product to be developed in Phaseis an FDA approved nucleic acid based diagnostic device paper dipstick test that contains a multiplex of probe that can amplify and detect nucleic acid sequences from the gametocyte specific pfstranscript anddifferent strains of malariaPlasmodiumPfalciparumPvivaxPknowlesiPmalariaePovale curtisiiPovale wallikeridirectly from CLBuffer stabilized blood without RNA extractionThe target sequences are amplified using the TARATemplate Assisted Rapid Assaytechnology which is composed of a template dependent chemical transfer reaction with high turnovergold nanoparticlesGNPand horse radish peroxidaseHRPdetection and lateral flow readoutThe test is rapidand results in the appearance of colored bands that are detectable by eyeThe test can detect parasites ltparasitesLand also detect parasites in asymptomatic individuals In Phasewe will conduct a large scale validation experiment to obtain expedited review approval and recommendation for procurement of our product from the WHOIn Phasewe will also develop a CrossLife mobile readercollaboration with NovarumDxfor our developed test cassette that will provide the user with unambiguous resultsby removing any subjectivityOur simple to use technology may be supplemented with test choreographythat aids to reduce error rates in the system even furtherand is particularly important for less trained healthcare workers