A Dublin-based medtech company that specialises in developing tests for infectious diseases has fast-tracked the development of a new, rapid test for the novel coronavirus, which it hopes could be on the market “in months”.
Hibergene, a diagnostics company founded in 2014, said its test will undergo clinical evaluation in China in collaboration with its local distribution partner based in Shenzhen.
The company’s test will deliver results within 60 minutes after preparation on a patient for five to 10 minutes. The test is known as a “near patient test” because it can be done in the same building in which a patient is located as opposed to in a laboratory.
Among the issues with coronavirus testing at present is a lack of physical symptoms in the early stages, a lack of accurate results from tests and the length of time it can take to get those results, according to Hibergene's chief executive, Simona Esposito. Its closest competitor in delivering a test for coronavirus can deliver results only after four hours.
The Sandyford-based company, backed by several investors including Cantor Fitzgerald and Enterprise Ireland, hopes to be admitted to fast-track approval for its test in China, where 42,708 cases have been confirmed, including 1,017 deaths.
It will also have to apply for regulatory approval individually in other countries.
The cost of its test will vary, but it will average $50.
Flu template
“Our research and development team have reacted quickly to the outbreak of coronavirus,” Ms Esposito said, noting that the company had used templates from its flu and other respiratory tests to develop a test for coronavirus.
In the six years since its foundation, Hibergene has launched 10 tests to diagnose respiratory illnesses, critical hospital infections and sexually transmitted infections. It is planning to launch two more tests for STIs.
“Our focus is in rapid, accurate diagnosis near patients instead of waiting for days or hours for results to come,” Ms Esposito said.
The company, which was targeting significant growth in China prior to the outbreak of the coronavirus, said the initial results for its tests had been positive and the company planned to validate its test in China by the second week in March, depending on the results of internal validation testing.
The company does not precisely know when approval will come, but Ms Esposito said the product “could be on the market in months”.
