NEW YORK (GenomeWeb) — Bay Area startup Diassess has been awarded nearly $300,000 from the National Institutes of Health for the first year of a two-year project to develop a point-of-care, nucleic acid amplification-based diagnostic device for sexually transmitted infections, with an initial focus on chlamydia.
According to the company, the goal of the Phase I Small Business Innovation Research project is to create a working prototype of a rapid, cheap, user-friendly test for Chlamydia trachomatis with sensitivity and specificity that is comparable to centralized molecular tests.
Should it achieve this goal, Diassess will then seek to test the device on a variety of sample types; develop primers against other STIs such as gonorrhea, human papillomavirus, and trichomoniasis; and ramp up clinical trials for the platform in the hopes of bringing a commercial product to market sometime in 2017, according to a recently published grant abstract.
"We've done some preliminary studies with patient samples, and right now it's very promising because we're getting very high levels of specificity and sensitivity, sort of equivalent to the gold standard PCR that is being done in centralized labs," Ivan Dimov, a cofounder and chief technology officer at Diassess and principal investigator on the new grant, which is being administered by the National Institute of Allergy and Infectious Diseases.
Diassess garnered its first NIH grant in late 2012 to support the development of a cartridge-based, POC device called SIMBAS, for Self-powered Integrated Microfluidic Blood Analysis System. Originally developed in the laboratory of University of California, Berkeley researcher Luke Lee — where Dimov was a former student — the platform was intended to enable multiplex detection of both protein and nucleic acid biomarkers.
Diassess has since diverged from that path, having developed a novel nucleic acid amplification method and associated device with some elements in common with the SIMBAS technology, but with some new elements, as well.
Dimov said that he was not at liberty to discuss the new technology in great deal since the company is still in the process of pursuing patent protection. However, he noted that "it's a nucleic acid amplification technology that we have invented a device around, and [we've also invented] some of the chemistry … in order to miniaturize everything and have it fit into a little cartridge." He did not comment on whether the company is still considering integrating protein analysis.
Dimov added that the platform is intended to be "highly disposable and low cost, and therefore hopefully amenable to be used in all locations where it might be necessary. The beauty is it doesn't require any additional infrastructure — it sort of runs by itself."
In 2012 Dimov told PCR Insider that the company had been exploring the use of loop-mediated isothermal amplification (LAMP), as well as an offshoot of that technology called digital LAMP, to support the nucleic acid detection and quantitation capabilities of the SIMBAS platform.
The new nucleic acid amplification technology has "some similarities but there are also differences," Dimov said this week. "We've developed a distinct chemistry that allows us to do the readout." Specifically, the system can currently multiplex 10 different reactions or targets in a single test, he said — something that has proven difficult for isothermal amplification methods to achieve.
The market for molecular diagnosis of chlamydia and other sexually transmitted infections is huge, with industry stalwarts such as Cepheid, Hologic, Roche, Becton Dickinson, and Qiagen all competing for a piece of the pie. But these vendors' tests are all generally administered from a centralized testing facility.
"We realized there is a need for a rapid nucleic acid amplification test, kind of similar to a pregnancy test kit, where it is very simple to use, doesn't require any infrastructure, [and] anybody can do it, even people who are not technicians or doctors," Dimov said.
Other academic groups and companies have made this realization, too. For instance, UK-based Atlas Genetics told PCR Insider last year that it was hoping to have a cartridge-based, POC nucleic acid-based test for chlamydia on the market by the end of this year. In addition, an academic group from the University of Tartu in Estonia, along with a startup company called Selfdiagnostics, published a peer-reviewed study late last year validating a POC chlamydia assay based on recombinase polymerase amplification.
And larger players have also taken notice: Waltham, Mass.-based clinical diagnostics firm Alere recently received US Food and Drug Administration clearance for its Alere i platform and associated flu assays. This small-footprint platform uses an isothermal amplification technology called nicking enzyme amplification reaction, and Alere told PCR Insider that it is currently developing a combined chlamydia and gonorrhea test for the system.
Dimov said that Diassess' platform is different from the majority of these technologies because of its all-in-one nature.
"Usually what we've seen in these other systems is that there is generally a separate kit … and then you need some infrastructure to do the incubation, the heating," he said. "Once you're done with that you sort of have to use lateral flow … for the readout. We don't use any lateral flow technology whatsoever, and that allows us really to multiplex. In that sense it's really similar to a pregnancy test where you just put the sample in and a number of minutes later you get your results out. It's rapid, all integrated, and multiplexed, and these are characteristics we haven't really seen in any products out there."
According to Diassess' NIH grant abstract, the company aims to develop a test that can perform DNA extraction in less than 10 minutes and multiplexed C. trachomatis detection and typing in less than 40 minutes.
Dimov added that the multiplexing capabilities may allow Diassess to develop multi-target STI panels, as well as tests for specific subtypes of various STI targets. For instance, he noted, drug-resistant strains of C. trachomatis have emerged in recent years, and it would be beneficial to be able to test for these simultaneously. "Also, when you multiplex you … can repeat the same test several times, basically, in one shot. That helps with precision and results."
Diassess also noted in its grant that once Phase I of its project is completed, it would require additional funds of approximately $3 million in order to scale up production and clinical trials in order to go to market in the third quarter of 2017. Some of those funds may be supplied by Phase II of the grant, but Dimov said the company is also considering private financing.
The company is collaborating on the development of the platform with Deborah Dean, a physician-researcher specializing in C. trachomatis at the Children's Hospital Oakland Research Institute.
"She's an expert in chlamydia and has been studying the bacteria for 20 years, understands the pathogen very well, has sequenced the genome and the different variants, [and] has samples from all over the world," Dimov said. "She has been and will be a key part of this project."