By Ben Butkus
BioHelix has received a two-year grant 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.
The platform will build on a previously published microfluidic chip designed by researchers at Boston University that uses BioHelix's helicase-dependant amplification technology, BioHelix President and CEO Huimin Kong told PCR Insider this week.
If BioHelix can achieve proof of concept for its device, it would then seek a commercial development partner – with diagnostics firm Quidel as a strong candidate. The companies are already co-developing molecular diagnostics for infectious diseases based on a first-generation version of BioHelix's technology.
"If things go well, it would make sense that Quidel might be interested in commercializing the device with us, because we already have an agreement with them, but we haven't talked with them specifically on that subject," Kong said.
Under the Phase I Small Business Technology Transfer grant, the first year of which is worth approximately $242,000, BioHelix will focus on developing a testing platform primarily for the sexually transmitted disease market, and more particularly for chlamydia and gonorrhea.
According to the NIAID grant abstract, the company seeks to address a perceived lack of low-cost, fast-turnaround molecular diagnostic tests that can be performed at the point of care in hospitals and doctors' offices.
"The scientific literature clearly shows that molecular testing is the most sensitive means of detecting [Chlamydia trachomatis] and [Neisseria gonorrhoeae]," the grant abstract states. What's more, the abstract points out that the US Centers for Disease Control and Prevention recommends that physicians use point-of-care diagnostic tests on patients suspected of being unlikely to return to the clinic to learn the results of the test.
"Unfortunately, there are no POC CT-NG molecular tests, and existing POC molecular testing systems like the [Cepheid] GeneXpert are too costly for use in STD clinics," the abstract states.
BioHelix proposes developing a low-cost point-of-care molecular diagnostic system using a design developed in the laboratory of BU's Catherine Klapperich and previously demonstrated to be compatible with BioHelix's isothermal helicase-dependent amplification technology (PCR Insider, 1/28/2010).
"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," BioHelix said in its grant abstract, noting that BU's current system uses a fluorescence microscope to detect product formation.
BioHelix instead envisages a device that will incorporate a lateral flow strip as a means of detecting the presence or absence of nucleic acid amplification products by simple visual inspection.
"Dr. Klapperich's lab … has developed these microfluidic cards, like a glass slide, that [are] … approximately a couple of millimeters thick. They've previously published that you can use that to do sample prep, isothermal amplification, and detection" using fluorescence microscopy, Kong said.
"In this project we propose combining these microfluidic cards 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."
In 2009, BioHelix and Quidel signed an agreement to jointly develop and commercialize in vitro molecular diagnostic tests for infectious pathogens in a non-instrumented, handheld format based on the helicase-dependent amplification technology.
As Quidel has shaped its molecular diagnostics strategy over the past several months, it has noted that it and BioHelix have in development tests for Clostridium difficile, methicillin-resistant Staphylococcus aureus, group B Streptococcus, meningitis, and tuberculosis, among others.
It is unclear when Quidel plans to commercialize this handheld molecular testing platform. Company representatives could not be reached for this article.
However, Kong noted that the companies are still in a "development phase," and that Quidel has in the past targeted a commercial release for the first half of 2012.
It remains to be seen whether Quidel will seek to adapt the technology being developed under the NIAID grant or whether BioHelix will need to seek a different development partner.
"This is just Phase I, feasibility," Kong said. "Our goal now is to make for the first time a low-cost, lateral flow strip-based, fully integrated detection device. We want to do the research first, and then hopefully get Phase II funding and demonstrate that it is manufacturable."
If this turns out to be the case, BioHelix "will then need more money for clinical trials, et cetera," he added. "At that point it might make sense to work with a Quidel or some other company."
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