The code was issued to Proteomics International USA for the company’s certified reference laboratory in Irvine, which is supporting the device’s commercial release across America.
Proteomics officially launched a next-gen PromarkerD test in the US last month at the annual meeting of the American Diabetes Association and began rolling it out in California. Currently, the test is paid for out of pocket.
The company last week presented its recommended US pricing to the Centres for Medicare and Medicaid Services for tests ordered from next year. The centres, which represent the US’s massive public insurance schemes, will release their preliminary pricing in September after consulting an internal clinical advisory panel.
Proteomics says the progress in the lucrative and influential US market means PromarkerD is now well-positioned for global commercialisation and expanded regulatory approvals.
It may be the first cab off the rank in Proteomics’ expanding arsenal of precision diagnostics targeting areas of unmet need, developed from its protein biomarker research and powered by its cutting-edge Promarker platform.
The company’s standard protein blood test is also behind its PromarkerEso test for oesophageal cancer and PromarkerEndo diagnostic for early-stage endometriosis.
Bringing any new medical treatment or device to market always requires years of labour. With the lab work under its belt, Proteomics is now ticking off the regulatory checklist for PromarkerD at pace, putting the company well on its way to achieving a revolution in diabetic care.
Is your ASX-listed company doing something interesting? Contact: mattbirney@bullsnbears.com.au
About The Author
