The complexities involved have proven too much for the projected Q2 launch, said the company.
Perth-based medtech Proteomics International has been forced to delay the US launch of PromarkerD, its predictive test for diabetic kidney disease.
In partnership with its US licensee pathology group Sonic Healthcare, Proteomics had planned to launch the test in the second quarter of this year.
Based on its latest assessment of the necessary technical and commercial work required to launch PromarkerD, the US lift-off “is now likely to be delayed”, said the company’s announcement.
“The work required to launch a novel test has multiple components and, while considerable progress has been made preparing PromarkerD for the US market, the complexities involved in bringing a new test into broad clinical use have meant the process is taking longer than expected,” it said.
“Significantly, our experience with PromarkerD has provided the company with invaluable knowledge and experience to accelerate the commercialisation of other tests in development.
“To this end, the necessary technical work has already commenced to prepare for the commercialisation of PromarkerEndo, the company’s test for endometriosis, and PromarkerEso, the company’s test for oesophageal cancer.”
