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Canada's GenePOC Eyes 2014 for Point-of-Care MDx System, Group B Strep Test

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Canadian molecular diagnostics firm GenePOC has completed technical development of its benchtop, point-of-care molecular diagnostic system and disposable test cartridges, and has commenced clinical feasibility studies of the platform, company executives said this week.

In addition, the company hopes to begin clinical trials for its first commercial assay – a molecular test to detect group B streptococcus in pregnant women – by the end of 2013, with the hopes of launching the assay and its system, called GenePOC Diagnostics, by the end of 2014.

In the meantime, GenePOC is seeking investors and commercial partners outside the infectious disease diagnostics arena to buoy the company as it shepherds its platform toward the market, executives said.

Based in Québec City, Canada, GenePOC was founded in 2007 by Michel Bergeron, who currently serves as chairman of the board and a professor and director of the Centre de Recherche en Infectiologie, or CRI, at Laval University.

Bergeron is widely regarded as one of the earliest innovators of molecular diagnostic technology, having been instrumental in developing the first molecular test for group B Streptococcus, or GBS, to be approved by the US Food and Drug Administration in the early 2000s.

To commercialize the assay and other rapid molecular tests, Bergeron subsequently founded Infectio Diagnostic, which in 2004 was acquired by GeneOhm; which itself was acquired in 2006 by Becton Dickinson and continues to operate as a division of BD in Québec.

GenePOC's goal, working closely with Bergeron's lab at Laval University, has been to bring molecular tests such as the ones Bergeron developed earlier in his career, to the point of care, GenePOC CEO Patrice Allibert told PCR Insider this week.

"There is still a huge amount of space to cover [in molecular diagnostics], and point of care is one, so now GenePOC is pushing [Bergeron's] vision to the next step: the way [molecular diagnostics] are being used in the lab."

Numerous companies and research groups are developing platforms designed to decentralize molecular testing from core laboratories to hospitals, emergency rooms, and physicians' offices.

However, GenePOC believes that several aspects of its system, called GenePOC Diagnostics, provide it an advantage over other technologies aimed at the point-of-care molecular diagnostics market.

"It is designed to be very user-friendly … and very small and fully integrated," Allibert said.

The prototype GenePOC Diagnostics instrument is small enough to sit on a laboratory bench. The instrument accepts up to eight different disposable "pie-shaped" microfluidic cartridges into which a raw sample is loaded. The cartridges are placed around a rotor that provides centripetal force to drive the sample through all preparation, RT-PCR-based nucleic acid amplification, and detection steps.

Each disposable contains three PCR cuvettes, and four different targets, through the use of four dyes, can be detected in each cuvette, Allibert explained.

"For [a] low-complexity test like GBS, only the first cuvette will contain the master mix ready to use," he said. "For a medium-complexity test requiring up to eight different [targets], cuvettes one and two will contain the master mix. For a high-complexity test, cuvettes one, two, and three will contain the master mix."

The upshot is that the system can detect up to 12 targets per sample – a key requirement for assay panels such as tests for respiratory infections, enteric infections, meningitis, sepsis, or tuberculosis, Allibert noted.

The system is operated through a touch-screen interface, and can provide test results in less than an hour with less than three minutes of technician hands-on time, according to the company.

Other advantages, according to Allibert, include a universal sample prep method that involves shaking glass bead technology developed in Bergeron's lab. The sample prep method completely lyses any bacterial or other cells, releasing genetic material for subsequent testing.

"We have data in house showing that it has been tested and works with all kinds of samples, like nasal swabs, vaginal swabs, rectal swabs, stool, urine – we don't need to adapt sample prep to the sample type," Allibert said.

In addition, "one aspect … that is receiving very strong and positive feedback from the field [is that] our disposable is very small and light … compared with the competition," Allibert noted. "The treatment of biological waste is becoming very complex to manage and at the end very costly … for any lab or hospital."

And cost is the final area where GenePOC hopes to differentiate itself from competition.

"The POC market is clearly cost-driven," Allibert said. "We target a machine price [of] not more than $30,000." He noted that the company could not yet provide a target price range for its disposable cartridges, but said that they will also be "cost effective if compared with current tests."

For comparison, Cepheid's GeneXpert IV instrument, which features four individual GeneXpert modules and thus is capable of running four individual tests simultaneously, retails for around $78,000, a Cepheid executive said at a recent investor conference.

GenePOC Diagnostics will be a closed system, at least for infectious disease testing, and GenePOC is planning to develop a full menu of assays that it deems appropriate for point-of-care testing.

"The menu for point of care is not so far from the menu of regular molecular, but the ranking is not the same," Allibert said. "You have to identify the ones where there is really a direct impact – what happens when I can provide a result in one hour? If that can have an immediate impact on the patient, then that is ideal for point of care. If not, then … it is important, but not on the top of the list."

On the top of GenePOC's list is its GBS assay, which could help address a serious complication that can occur in pregnancy: a mother infected with GBS can pass it on to her fetus during birth, potentially threatening the life of the newborn.

"GBS is really an example of where … this kind of technology … can save lives at the point of care," Allibert said. "The mean time for delivery is four hours, so when [a woman] comes to the hospital for delivery, the first thing to do is take a vaginal swab, run the [GBS] test, and information is available one hour after."

If the mother is positive for GBS, he noted, she can be treated with antibiotics before giving birth, thus helping to protect the infant. "To be successful there, you need to have the [assay] inside or very close to the delivery room," Allibert said. "This is one way we will [demonstrate] the power [GenePOC Diagnostics] will bring."

GenePOC is also eyeing assays for hospital-acquired infections such as Clostridium difficile, methicillin-resistant Staphylococcus aureus, and other multi-drug resistant bacteria implicated in sepsis.

But first the company will be putting its resources into clinically vetting its platform and first test for GBS. It has just begun clinical feasibility testing, and clinical testing to support a submission to the US Food and Drug Administration will "not be before the end of next year," Allibert said. However, he added, the company expects to have its GBS test and platform on the market "toward the end of 2014 … and about four or five more tests sometime in 2016."

So far, Bergeron has personally funded much of GenePOC's development, Allibert said, but the company is now actively seeking investors to help it move its platform toward market. GenePOC is also open to discussions with partners in other industry sectors where rapid, multiplex molecular testing is desirable.

"Our machine could potentially be of interest to pharma companies for molecular [companion] diagnostics; or in food [and] agriculture [testing]," he said. "All of these areas are not where GenePOC wants to go first, so if a partner is interested, this will be a key aspect of our strategy."

And, GenePOC may continue to mine innovations coming out of Bergeron's Laval University lab, a setup that Allibert claims gives the company a unique advantage over many of its competitors.

For instance, Bergeron's lab is in the midst of a five-year project funded by the US National Institute of Allergy and Infectious Diseases to develop a viral respiratory tract infection panel using a molecular testing platform that is very similar to GenePOC Diagnostics.

Bergeron's group is slated to receive $823,000 from NIH in 2012 to support the project, which runs through June 2015. According to the grant's abstract, the researchers will develop a "microfluidic centripetal device" to detect a variety of respiratory viruses. The proposed system will be designed to process nasopharyngeal swab samples, extract and purify viral RNA or DNA, amplify and label nucleic acids, process labeled amplicons, hybridize them on low-density microarrays, and provide a clinically useful result within one hour.

"This is more or less the same [platform], and of course several [aspects] of the technology are very similar," Allibert said. "But they … don't have the same requirements; the respiratory panel is much more complex." For instance, the use of low-density arrays may be necessary to detect more targets than the GenePOC Diagnostics system can currently detect.

"This is another alternative approach potentially useful in the future, but it is not for GenePOC today," Allibert said.

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