Novacyt announces new molecular diagnostic multiplex test

Clinical diagnostics specialist Novacyt announced the successful development of a new molecular diagnostic multiplex test for respiratory infections on Monday, which it said was ready for launch in North America in time for the United States cold and flu season.

The AIM-traded firm said its molecular business unit, Primerdesign, had completed the design and development of the molecular respiratory panel based on a 384 well plate format for use by its North American business partner in their CLIA-approved diagnostic testing laboratory network.

Primerdesign had designed the multiplex test to identify 37 respiratory pathogens, which Novacyt claimed made it “one of the most comprehensive” respiratory panels available in the market today.

In addition to identifying a large number of respiratory disease pathogens, the company said the new diagnostic product had been designed with proprietary freeze-drying technology to stabilise the product to optimise its ease of use and performance.

Primerdesign would supply the product under a five-year manufacturing agreement, as its partner launched the new respiratory panel in the US market through its own clinical testing laboratories to provide a laboratory developed diagnostic test result for its customers.

The initial order for $0.11m had been received by Primerdesign to supply its US partner.

Novacyt said the global respiratory disease testing market was valued in 2016 at $5bn, and was forecast to grow at a rate of 3.3% per annum.

The US market accounted for more than 30% of the global respiratory testing market.

“This development marks a significant step forward in the group's B2B strategy by providing our North American business partner with the opportunity to access the significant demand for the US seasonal respiratory testing market, which typically runs from September to April,” said Novacyt group chief executive officer Graham Mullis.

“It also demonstrates the increasing capability of Novacyt's research and development team as it broadens its product portfolio and builds the skills to develop more complex products.”

Mullis said the rapid development of the new multiplex molecular diagnostic panel showed the power of the firm’s integrated research, development and commercialisation team.

“We believe this will be an important tool for clinicians to better serve patient needs.

“This is just one of a number of different assay panels being developed by Primerdesign.”