RE: Who to believe, world renowned JEFFRIES or those on this board…7 Jan 2024 11:12
Directly from the CEO himself in July 2023.
ANGLE can only promote the FDA cleared Parsortix PC1 clinical system for its intended use (for harvesting CTCs from the blood of metastatic breast cancer patients for subsequent user validated analysis). However, a third-party laboratory could adopt the system on a research use only basis (RUO) and then develop tests for alternative cancer types. To then offer the tests to clinicians for patient management, the laboratory would need to be CLIA accredited (or equivalent in their country) and then validate the test in its own laboratories before offering it as a lab developed test (LDT). This is common practice in the US and elsewhere. There are approximately 320,000 CLIA accredited labs in the US. Not all of these will be offering tests for oncology, but the number will still be very large and the market is therefore substantial. It is a challenge to make labs aware of the technology, but this is a key reason why we have built out a global network of distribution partners who are already selling instruments and consumables into the oncology market. We have also built out our own in-house marketing team and we attend a large number of relevant conferences throughout the year where we are able to showcase our capabilities.