By Ben Butkus
Startup molecular diagnostics firm GenturaDx has developed a molecular diagnostic system that combines sample preparation and real-time PCR testing on a disposable cartridge in an effort to bring molecular testing to more laboratories at small- and medium-sized hospitals, the company said this week.
GenturaDx is currently preparing to place the platform, called IDbox, in the hands of beta customers by the beginning of next year to evaluate initial multiplex tests for herpes simplex virus and respiratory viruses. The goal is to commercialize the system in Europe by the fourth quarter of 2011 and in the US by 2012, according to a company executive.
In addition, GenturaDx has licensed from Elitech Group subsidiary Epoch Biosciences the rights to minor groove binder technology and more than 25 analyte-specific reagent-based assays for various infectious diseases, which gives the company a set of validated technologies with which to pursue its goal, the company said.
The Emeryville, Calif.-based company unveiled the IDbox system this week at the Association for Molecular Pathology meeting in San Jose, Calif.
The self-contained system will allow for sample processing of one to 12 samples per instrument in two to four hours, according to the company. In an interview with PCR Insider, GenturaDx President Mark Bagnall said the company's goal was to build a system that "removes barriers to broad adoption" and "delivers the highest possible performance for the best possible price."
The only other barrier for adoption is ease of use, "and we aim to deliver a really easy-to-use system," Bagnall said. "Everything is in the cartridge. You simply add the sample, and as we say, 'Press play and walk away.'"
GenturaDx hopes that the first commercial iteration of its platform will be immediately awarded a moderate complexity rating under Clinical Laboratory Improvement Amendment guidelines, but expects future generations of the instrument to be CLIA-waived for point-of-care testing.
With the launch, GenturaDx is betting that it can grab a piece of the market for easy-to-use molecular diagnostic testing that has recently come to be dominated by Cepheid, whose Xpert line of tests for the GeneXpert and GeneXpert Infinity systems also provides hospital laboratories with fully integrated, PCR-based testing on a disposable cartridge.
"Cepheid has done a great job, and they've made a market that didn't exist," Bagnall said. However, in interviews with more than 200 laboratory managers in the US and Europe, GenturaDx found that "there is still a big need" for high-performance, low-cost, easy-to-use molecular testing in clinical laboratories, mostly at small- to medium-sized hospitals and even physician's offices and clinics.
"We recognize that there are some barriers that systems like [Cepheid's] present," Bagnall said. "But our mission is to try to get molecular testing distributed as widely as possible … and what's tough for these small hospital labs is capital costs.
"Most of our energy was focused on designing a system that would meet their needs where the capital costs would be less than competitors," he added. "We are targeting a considerably lower price per throughput for our system than companies like Cepheid."
Bagnall said that GenturaDx has not yet decided on an anticipated price point for IDbox, but that the company believes it is "offering a different value proposition at a price point that will be attractive to any labs that want a molecular diagnostic product."
As an example, he said that the one of the company's first anticipated tests, a respiratory panel covering influenza A, influenza B, and respiratory syncytial virus, "will be the first fully automated A/B RSV test on the market, and it will be offered at a price that allows hospitals to save money versus their send-out costs, as well being comparable to their full costs of running manual assays."
To be sure, GenturaDx has an intimate understanding of the market and of Cepheid's place in it, as several GenturaDx executives previously held positions with the Sunnyvale, Calif.-based firm. These include co-founder and Chief Scientific Officer Jesus Ching, who previously served as director of research and development at Cepheid; and Deborah Wright, GenturaDx's vice president of operations, who was also vice president of operations at Cepheid.
Bagnall said that while "a number of employees previously worked for Cepheid, it was through the combination of many employees’ diverse backgrounds and talents that we created a system that will be highly differentiated in the market." He added that the company has expertise "in all areas of system development, assay development, and systems integration."
GenturaDx used that expertise to design and develop the IDbox platform — meaning the instrument, disposable cassettes, and software — completely in house. To enable molecular test development for the platform, GenturaDx struck a deal late last year to acquire a license to Epoch's MGB PCR technology as part of now-bankrupt Nanogen's sale of Epoch's assets to French diagnostic firm Elitech.
Bagnall said that GenturaDx has a co-exclusive license with Elitech to use the MGB technology in any closed system such as IDBox. "We were very fortunate to get that deal, because it's comprehensive, and because of the circumstances we were able to get a deal done on good financial terms," thought he did not elaborate.
As part of that deal, GenturaDx also gained access to more than 25 ASR assays for various infectious diseases. "These assays have actually already been sold as ASRs, and they've already been validated," Bagnall said. "For us, to be able to know that we already have assays that work and that people are familiar with was a huge step … and it gives us confidence that the assays will perform well once on the market."
According to Elitech Group's Epoch Biosciences website, the company offers ASRs called MGB Alert detection reagents for diseases such as BK virus, cytomegalovirus, Epstein-Barr virus, and enterovirus. GenturaDx said that it will focus its initial test development on respiratory viruses and women's health; and that its first two tests — the RSV panel and a test for HSV I and II — will also be based on the Epoch ASRs.
GenturaDx has filed for multiple patents on the IDBox technology and, combined with the licensed technology, the company has "a solid IP portfolio … with issued patents, pending applications, and licenses to more than 100 allowed patents," Bagnall said.
The company has 32 employees and has received an undisclosed amount of financing from two main investors, San Francisco's Bay City Capital and Chinese financier DT Capital.
Bagnall said that the company is currently in the process of raising additional funds to begin clinical trials for tests on the IDbox in 2011.
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