Beverly, MA (October 14, 2011) –BioHelix has received a two-year Small Business Technology Transfer (STTR) from the National Institute of Allergy and Infectious Diseases to develop a fully integrated point-of-care molecular diagnostic device based on isothermal amplification and lateral flow detection technologies.
Under the Phase I STTR grant, BioHelix will collaborate Boston University to develop an integrated low-cost point-of-care molecular diagnostic system based on a microfluidic chip design developed in Dr. Catherine Klapperich’s laboratory at BU. Dr. Klapperich’s team previously demonstrated their microfluidics chip is compatible with BioHelix's isothermal Helicase Dependent Amplification (HDA) technology.
"Although the current BU disposable can perform our proprietary isothermal amplification reactions, it does not allow for low-cost, instrument-free detection of amplification products," commented Huimin Kong, President and CEO of BioHelix. "In this project we propose combining these microfluidic chips with a lateral flow strip," he added. "So you do sample prep, then you do amplification on the card, and at the end the sample will move through the lateral flow strip for detection. It will be a single-use, disposable, integrated device."
BioHelix’s first product line is based on the IsoAmp® platform, which consists simple sample preparation, isothermal amplification on a heat block, and instrument-free detection using a lateral-flow strip embedded in a plastic cassette. Last month, FDA cleared BioHelix’s first IsoAmp test, the IsoAmp HSV Assay for the detection of HSV-1 and HSV-2 in genital and oral lesions.