RE: Sales14 May 2020 13:01
We need more details on the following news, - like
a) how many pathogens tested all together or are pathogens tested serially, & speed of testing?
b) what test kit sales are forecasted for this instrument?
c) the first FDA cleared host response test for suspected sepsis patients, - more details required
During the year, Primerdesign also 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 designed the multiplex test to identify 37 respiratory pathogens, which makes 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 new diagnostic product was designed with proprietary freeze-drying technology to stabilise the product to optimise its ease of use and performance.
Primerdesign will supply this product under a five-year manufacturing agreement as its partner launches the new respiratory panel in the US market through its own clinical testing laboratories to provide a Laboratory Developed Diagnostic Test ("LDT") result for its customers.
The global respiratory disease testing market was valued in 2016 at US$5.0 billion1 and is forecast to grow at a rate of 3.3% per annum. The US market accounts for more than 30% of the global respiratory testing market.
1 Respiratory Disease Testing/diagnostics market, Industry Report, 2025 Grand View Rese
This development marked a significant step forward in the Group's B2B strategy by providing our North American business partner with the opportunity to serve the significant demand for the US seasonal respiratory testing market, which typically runs from September to April. It also demonstrated the increasing capability of Novacyt's R&D team as it broadens its product portfolio and builds the skills to develop more complex products. The rapid development of this new multiplex molecular diagnostic panel shows the power of our integrated research, development and commercialisation team.
In addition, during the year, Primerdesign expanded its assay development contract with Immunexpress, Inc., a U.S.-based molecular diagnostic company, with the first FDA cleared host response test for suspected sepsis patients. This is to further support the development of rapid diagnostic assays for the detection of sepsis. Sepsis is a potentially life-threatening complication in which a person's immune system inappropriately responds to an infection by triggering a broader inflammatory response, which could cause damage to multiple organs and ultimately lead to death. Left undiagnosed or untreated, a patient could die within a matter of hours. This contract expansion adds further momentum to our B2B segment and provides further validation of the expertise our clinical assay development service offers.