- Proteomics International Laboratories (PIQ) has filed a pre-submission package to the United States Food and Drug Administration (FDA)
- The company is seeking additional regulatory approval for the kit version of its PromarkerD diabetic kidney disease test
- Proteomics expects to meet with the FDA to progress clearance within 10 weeks
- With FDA clearance and CE Mark approval, the company will have access to over half of the global IVD diagnostic market
- Proteomics International Laboratories is up 4.58 per cent and trading at 80 cents per share
Proteomics International Laboratories (PIQ) has filed a pre-submission package to the United States Food and Drug Administration (FDA).
The company is seeking additional regulatory approval for the kit version of its PromarkerD diabetic kidney disease test.
Promarker D uses a unique protein fingerprint to predict the onset of diabetic kidney disease up to four years before clinical symptoms start to develop. If doctors can accurately diagnose people who are at risk of developing Type 2 diabetes, they can provide treatment plans that could delay or even stop the disease entirely.
As part of the pre-submission process, Proteomics will meet with the FDA to consult on the best regulatory path for PromarkerD. During this time, the company will present the FDA with peer-reviewed clinical performance data, which demonstrates the effectiveness of the test.
Proteomics expects to meet with the FDA to progress its clearance within 10 weeks.
If PromarkerD gains FDA approval, the company will be able to deploy its easy-to-use, inexpensive blood test throughout the United States.
The PromarkerD test already has CE Mark approval in the European Union and would benefit greatly from approval by the FDA.
The company’s Managing Director, Dr Richard Lipscombe, stated that FDA approval would be a significant commercialisation milestone for PromarkerD.
“FDA sign-off would assure potential licensing partners and consumers that the test has been developed and manufactured to US safety, health, and environmental protection standards,” he said.
“We CE Mark approval and FDA clearance, we would have access to more than 70 per cent of the global IVD diagnostic market,” he added.
Dr Lipscombe also noted that the company’s progression towards FDA approval for PromarkerD has conveniently coincided with increasing demand from U.S. diagnostic companies to broaden their testing capabilities.
Proteomics International Laboratories is up 4.58 per cent, trading at 80 cents per share at 1:24 pm AEDT.