Having recently been awarded a key US patent, Irish molecular diagnostics shop HiberGene hopes to commercialize its first assay — a loop-mediated isothermal amplification-based test for meningococcal meningitis — in Europe by the end of this year, CEO Tony Hill told PCR Insider recently.
According to Hill, the test is expected to allow HiberGene to tap into an underdeveloped market in the UK for rapid, near-patient molecular testing of meningitis, which is crucial due to the often rapid and aggressive progression of the disease to a life-threatening condition.
In addition, HiberGene plans to rapidly expand its menu over subsequent months with similar LAMP-based assays for pneumococcal meningitis and group B streptococcus, and is aiming for US Food and Drug Administration approval of its meningococcal meningitis test by the end of 2014, Hill said.
HiberGene spun out of University College Dublin in 2009. In 2011 it exclusively licensed patent applications surrounding its meningitis test from Belfast Health and Social Care Trust after doctors at BHSCT's Royal Victoria Hospital discovered how LAMP could be used to detect the presence of Neisseria meningitides, the primary causative agent of meningococcal meningitis.
HiberGene in February began manufacturing its first assay, expecting both a US and European patent to issue this year so the company could move forward with commercialization plans. The US Patent, No. 8,465,927, issued in June, was an important milestone for the company, Hill told PCR Insider, adding that issuance of the European patent is likely close behind.
The company has also been in negotiations to license LAMP, which is owned by Japan's Eiken Chemical, for human diagnostic use. Hill noted that terms for a deal are in place but that a contract has not been signed.
HiberGene is eager to get its test to market after the UK's National Institute of Clinical Excellence in 2010 issued guidelines for management of bacterial meningitis that included a recommendation for PCR-based testing for the disease, but also noted that the money and infrastructure needed to implement such testing across National Health Service labs was lacking.
"There are PCR-based tests available, but they seem to be more centralized solutions — reference lab testing," Hill said. "With meningitis it's important to get an extremely fast and accurate result … in a near-patient setting. The disease progresses very rapidly, and is very aggressive when it does."
LAMP has been established as a desirable alternative to PCR for near-patient settings for a number of reasons, particularly because it doesn't require expensive or complicated equipment to perform, and HiberGene's test is no different in that regard.
The assay is performed on blood, cerebrospinal fluid, or nasopharyngeal swab samples, which are placed into a test tube that is inserted into a benchtop reader designed by an undisclosed OEM firm to be "highly portable and very simple to use," Hill said.
The instrument provides the necessary constant incubation temperature of around 65° C, and provides endpoint luminescence-based detection of amplicons. Hill said that the platform's endpoint detection technology is capable of quantification and of multiplexing more than one target in a single tube, but noted that the first few tests from the company would be single-target, qualitative assays. In addition, up to eight assays can be performed on the instrument simultaneously.
The assay provides results on site in about 40 minutes, compared to one to two days for either culture-based methods or PCR testing in a centralized laboratory. Even though HiberGene is promoting the near-patient nature of its test, Hill noted that its workflow would likely garner a CLIA "moderately complex" rating in the US.
The company has demonstrated 100 percent sensitivity and 99.7 percent specificity for the assay in clinical studies. The assay will likely be commercialized to work with blood or CSF samples in order to meet diagnostic guidelines, but if HiberGene can demonstrate similar performance from nasopharyngeal swabs, that sample type would become an option.
"But one of the other benefits of LAMP is that it can use a relatively dirty sample," Hill said. "The extraction process is very quick and simple. For blood, the standard method takes about 10 minutes."
Hill said that HiberGene believes it will garner CE marking for its assay by the end of the year, and that the company is looking to commercialize similar tests for pneumococcal meningitis and GBS "three to six months after that."
Regarding US commercialization, HiberGene plans to have 510(k) clearance for its assay within a year. "We've had regulatory experts give a considered opinion of it," Hill said. "We know there's predicate devices, people that have developed and registered LAMP-based tests."
One well-known example is US clinical diagnostics company Meridian Bioscience, which has commercialized several LAMP-based diagnostic tests, although not for meningitis.
Hill also said that HiberGene has identified 13 other targets for various infectious diseases that it plans to use to quickly build out its test menu.
"Some of those will be multiplexed tests … and the fact that our instrument allows us to do quantification … also sets us apart," he said, noting that this would allow the company to develop assays for things like viral load.
HiberGene is currently in the process of raising private funding to fuel its commercialization efforts. "We've made a lot of progress over the last few months, with lots of interested parties doing due diligence," he said. "The expectation would be that we can close it out in the next few months, which would let us press ahead with product development plans. And those would entail us using a variety of sources to develop products, both in house, and via external developers or licensing. We see it as being very important that we can grow our menu quickly, which will enable us to more easily place instruments."