By Ben Butkus
Startup molecular diagnostics shop GenturaDx presented data today demonstrating that an assay for herpes simplex virus run on the beta version of its fully integrated, sample-to-answer molecular testing platform has sensitivity and specificity comparable to or greater than three commercially available HSV assays.
GenturaDx sees the early data as a significant stepping stone in its quest to obtain regulatory approval for its test from the US Food and Drug Administration by 2013; and is betting that it will attract potential development partners to help the company build out a molecular test menu for its platform, company executives said this week.
Based in Hayward, Calif., GenturaDx first unveiled its platform, called IDbox, last November at the Association for Molecular Pathology meeting in San Jose, Calif. (PCR Insider, 11/18/2010).
IDBox, which the company has said in many ways follows the blueprint of Cepheid's successful GeneXpert platform, combines sample preparation and real-time PCR testing on a consumable cartridge that is inserted into a benchtop reader for detection.
The self-contained system can process between one and 12 samples in two to four hours, and is designed to enable "walkaway" operation by relatively untrained lab technicians. Like Cepheid, GenturaDx is targeting clinical laboratories, mostly at small- to medium-sized hospitals and physicians' clinics, with the goal of making molecular testing as widely available as possible at a low cost.
Banking on the idea that the proprietary design and operation of IDbox would differentiate it from other platforms on the market, GenturaDx also last November licensed from Epoch Biosciences minor groove binder technology for its real-time PCR assays, as well as more than two dozen analyte-specific reagent-based assays for various infectious diseases, giving the company well-vetted assay technology with which to develop its own tests.
GenturaDx had said that it would focus its initial test development efforts on respiratory viruses and women's health, and more specifically said that its first two tests would be a respiratory viral panel and an assay for HSV 1 and 2 detection and typing.
Today, at Select Biosciences' Molecular Diagnostics World Conference in South San Francisco, GenturaDx shared some of the first internally generated data demonstrating the high degree of sensitivity that IDbox can achieve.
Specifically, GenturaDx compared the performance of its herpes simplex virus 1 and 2 assay for the IDbox with Roche's LightCycler HSV 1/2 qualitative kit, which is CE-IVD marked but available for research use only in the US; Eragen's MultiCode-RTx HSV 1&2 kit, which received 510(k) approval in the US in May 2010 (PCR Insider, 5/19/10); and Epoch Biosciences' ASR test kit for detecting but not differentiating between HSV 1 and 2.
When comparing non-typing performance, the company said IDbox yielded a detection rate of 86 percent compared to 82 percent for the Epoch ASR test; 78 percent for Eragen's assay; and 29 percent for the Roche test.
Meantime, when compared to the two typing tests, IDbox resulted in a detection rate of 91 percent for HSV 1 compared to 86 percent for EraGen and 19 percent for Roche; and 81 percent for HSV 2 compared to 69 percent for EraGen and 39 percent for Roche.
GenturaDx also noted that IDbox demonstrated a sensitivity of lower than five copies of target nucleic acid per µL; and showed linearity over four to five logs.
The upshot, according to Geoff McKinley, senior vice president of R&D at GenturaDx, is that IDbox "compares very favorably — equal to or better than all three of the systems" for HSV 1 or HSV 2 detection.
"What allows us to have an advantage to detect low copy numbers … is that we are able to pull a greater amount of our elution over to the PCR reaction than other systems do on a routine basis," McKinley told PCR Insider. "This is all pre-defined within our cartridge, because we have complete control from once our sample goes in to sample prep and detection. We eliminate all the hands-on time usually needed to do all that, which is another key aspect; and provide very sensitive results."
McKinley added that the company also believes that IDbox's full integration provides an advantage over the comparator assays, which "contain multiple pieces."
GenturaDx President and CEO Marc Bagnall told PCR Insider that the company was very encouraged by the "robustness of the system and the reproducibility of results."
"We have now generated a nice amount of data demonstrating that between instruments and between cartridges in an [IDbox] instrument you get highly reproducible results," Bagnall said. "All together we're very … optimistic about what these types of data do for us in terms of our ability to commercialize the product and attract other people to commercialize their assays on our system."
To that end, Bagnall said that GenturaDx continues to work on its own assays for IDbox, but is also talking to partners for potential assay development.
"We'd like to be able to expand the platform … into other areas of infectious disease and areas beyond infectious disease," he said. "We've got discussions with people who have complementary infectious disease programs; unique chemistries; and people who are outside of the area completely."
At the UBS Global Life Sciences conference last week in New York, Bagnall told investors that the company hoped to reach a development deal with a partner in the first quarter of 2012. He also noted that GenturaDx plans to submit its platform, which would be priced at around $50,000, for FDA approval in early 2012.
Around the same time the company hopes to begin clinical trials for its HSV assay in order to submit it for FDA approval by Q4 2012 with an eye toward a commercial launch in the first half of 2013.
Meantime, the company hopes to initiate beta studies for its respiratory virus panel in the third quarter of next year; and continue developing a Clostridium difficile assay, targeting a commercial launch in the second half of 2013 for both tests.
Bagnall also told PCR Insider this week that in addition to its regulatory timeline goals, "we're beginning to roll out… a program starting now that will evolve over the next few quarters to start evaluating the system" with independent laboratories.
Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.