Hi Aruc,
In a nutshell and from the ANN:
“The results form an essential basis for regulatory approvals related to the PromarkerD test system and its adoption by pathology laboratories worldwide. Importantly, they also illustrate the potential for adoption of the PromarkerTM diagnostics platform in future clinical practice.”
If you read the studies (listed in the ANN), they are validating different things in relation to Promarker D: Predictive diagnosis of DKD & decline in renal function, currently monitoring of patients on treatment with Canafliglozin, validation of the PromarkerD diagnostic platform and technical analysis, and by independent laboratories. Importantly it’s peer reviewed research & validation of the test (a very quick & basic description).
The really good news is that results have been positive, in multiple validation studies - we move forward with regulatory approval & commercialisation & excellent patent protection.
There are many tests that fail independent validation, just think about the big hoo haa over Rapid Covid-19 POC tests, I think only 6 were finally approved by the TGA, and many failed also in FDA & approval in the UK & Europe on large discrepancies in Sensitivity & Specificity claimed by manufacturers, ie they are inaccurate, so pose a danger to public health.
We are not one of those companies & in fact have received a Govt grant for the development of COVID-19 testing (severity of disease biomarkers & also a saliva based diagnostic test).
Looking forward to more news on PromarkerD soon.
GLTAH
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Hi Aruc, In a nutshell and from the ANN:“The results form an...
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