FDA advised PIQ that they don't need full approval as it is a...

FDA advised PIQ that they don't need full approval as it is a low risk test. They are using a De Novo pathway. It's in the 2022 annual report. So this code is all they need to market the product and get paid. I'm not across the US medical industry. But even in Aus there are approved medical products/procedures that not every insurer will cover. They all cover different things. This is a brand new test. But ultimately, it is a test that will easily save insurers money by reducing the need for more costly procedures down the track. So it seems like a no brainer that they would support it.