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HiberGene Outlines Plans for Low-Cost Point-of-Care Molecular Diagnostic System

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NEW YORK – With a new CEO at the helm, HiberGene is refocusing its efforts toward research and development. The Dublin, Ireland-based firm is using low cost as the rubric in its development of a new point-of-care molecular diagnostics instrument that will be based on its core technologies.

Simona Esposito replaced CEO and co-founder Brendan Farrell, who retired last year, in April, after joining HiberGene as chief commercial officer nine months ago.

After a deep assessment of the firm's strengths, opportunities for improvement, and competitive dynamics, she has reoriented the firm.

"The strategy of the company, and the vision, have changed from a very strict commercial focus to a technology focus," Esposito said in an interview.

"We have recognized that this is our core competency, and we think that we have a big competitive advantage in terms of the technology achievements we have delivered already over the past five years" with regards to time and cost of testing, she said.  

The firm has already begun the development of a sample-to-result instrument with built-in connectivity, Esposito said, with low cost being a crucial element from the onset.

The core technology — loop-mediated isothermal amplification (LAMP) licensed from Eiken Chemical — helps keep cost down because the instrument does not need to include a thermal cycler. But all the components and design choices for the new instrument are also being made with an eye to the final cost, Esposito said, since HiberGene believes that affordability is the key to uptake in the point-of-care market. Keeping the instrument simple to use is also critical, as the firm also intends it to be suitable for a CLIA waiver.

The company has increased its R&D staff for the project but is also engaging with outside developers. It plans to enter the point-of-care market in the fourth quarter of 2021.

"We recognize that there is a big need that is untapped in the market right now to test infectious diseases in a way that is rapid, accurate, and affordable," Esposito said.

For the other manufacturers of point-of-care molecular test solutions, instrument cost has tended to be a sticking point for potential customers.

In the US, there are currently four CLIA-waived systems that test single targets or small multiplexed panels — the Roche Liat, Abbott ID Now, Cepheid GeneXpert Xpress, and Mesa Biotech Accula. The BioFire FilmArray 2.0 EZ Configuration is also CLIA waived with a respiratory test that is a multiplex panel to detect 11 viruses and three bacterial pathogens. In general, instrumentation for these systems can cost in the range of $10,000, although some firms have begun leasing instruments or offering them for free to drive assay purchasing.

HiberGene is now undertaking a fundraising effort to raise €10.7 million ($12 million) to develop and launch the new sample-to-results instrument. It also plans to partner with major players in the industry to deliver the product and accelerate sales.

The company sees a market for this new sample-to-answer system outside of hospitals, in places like physician offices, and even pharmacies.

HiberGene plans to sell the new instrument in Western Europe and the US, as well as in China, where it claims an early-mover advantage with completion of the trials to obtain regulatory clearance of its Group B Strep assay from the National Medical Products Administration, formerly the China Food and Drug Administration. It is currently seeing the biggest successes and taking the biggest volume share with its lab-based HG Swift instrument in Eastern Europe and Asia, Esposito said.

The firm will also keep an eye on growth and has already doubled sales year-to-date versus the prior year, Esposito said.

Specifically, HiberGene now has doubled the number of end users of the HG Swift system versus last year to 40 users. It is also expanding instrument utilization and is seeing customers using an average of 97 tests for each instrument so far this year, compared to 35 tests per instrument at this point last year. The increase includes both higher use of the tests the customers had already been using as well as cross-selling of the expanded test menu.

Esposito has leadership experience in business development and marketing at medical technology companies such as Johnson and Johnson, Olympus Medical, and GE Healthcare. Most recently, she was director of sales for international markets at Laborie, a Mississauga, Ontario-based medical device maker.

But the potential for technology leadership and the market opportunity in infectious disease diagnostics drew her from these more established players to early-stage HiberGene, she said.

HiberGene was founded in 2009 and currently markets laboratory-based diagnostic tests and instruments that rely on LAMP and proprietary chemistries and methods. To date, the firm has been selling its HG Swift instrument, which was launched in 2015, in Europe and Asia, and it now has a menu of 10 CE-marked assays that each run in under 40 minutes.

Overall, the menu on the HG Swift now includes 10 assays for critical infectious diseases, hospital-acquired infections, and women's health and sexually transmitted infections.

The menu initially focused on bacterial infectious disease diagnostics, including tests for Group B StreptococcusClostridium difficileMycoplasma pneumoniae, a bacterial meningitis test to detect all known Neisseria meningitidis serogroups, and a meningitis test combining targets for Neisseria meningitidis and Streptococcus pneumoniae. The Meningococcus tests also include one that can be used on whole blood or cereborspinal fluid sample types, one that is for direct swab samples meant for testing pre-school children, and a test directly from CSF samples.

HiberGene got the CE mark for its first viral test, a dual-target influenza A/B assay, in December 2018, and launched the test at that time. It subsequently received the CE mark and launched tests for RSV subtypes A and B in May, and a test for chlamydia and gonorrhea (CT/NG) in June of this year. Besides being a rapid point-of-care multiplex test, the latter also marks an expansion in the women's health and STI market from a base of GBS testing, and the company is also developing two new STI tests to complete this menu area, Esposio said. 

From a technology perspective, HiberGene now boasts several tests that use multiplex LAMP. This advance in the technology might also potentially help differentiate HiberGene from others that use the LAMP technology licensed from its developer Eiken Chemical, such as established companies like Meridian Bioscience and Rheonix, start-ups like Novel Microdevices and Talis Biomedical, researchers developing systems at places like Sandia National Laboratories and the University of Pennsylvania, and even Eiken Chemical itself.

The new HiberGene POC instrument is still being developed in partnership with an undisclosed OEM manufacturer. The HG Swift sells for €8,000, with individual assays costing approximately €25 each, as previously reported. The firm declined to provide an estimated price for the instrument in development but noted that it will aim for an affordable solution with target customers in countries with medium to low healthcare spending in mind.

HiberGene had previously described a timeline to bring its assays to the US this year, but Esposito said the firm has reconsidered. It now plans to enter US clinical trials for Food and Drug Administration submission once the point-of-care platform is launched in 2021, since the POC market is growing most significantly. "To go with our lab-based technology and platform at the moment would not make sense," Esposito said.

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