2017 The new Capital, page-580

Enlitic has a number of products at different stages of development / approval / clinical application. The 2 main ones we talk about are a chest x-ray triage tool and CT lung cancer screening tool.

Although the TGA (aust), FDA (US), and CE (Eur) differ in requirements for approval / registration Enlitic is taking a multi country / partner approach.

The lung cancer tool is currently the subject of a major piece of work in the US with prominent institutions the outcome of which we hope will be a peer reviewed publication about its use. This will then be a precedent for clinical acceptance and FDA applications.

In Australia we are progressing the Chest X-ray triage tool. Its registration / approval with the TGA depends upon its use case. If it is used to influence the Dr at point of care it requires a higher level of approval by the TGA. If it does not like, a post QA review it requires only technical registration.

We intend as announced to use it as a QA tool to review at the end of each period – say each week – the chest x-rays that are reported at Capital clinics. Then the tool provides feedback to the reporting Dr, allowing the Dr to agree or not and feedback to the algorithm.

This has a number of benefits:

• It is a Dr assistant
• It allows Capital to be one of the only networks that has QA review on every case – therefore improving accuracy and reputation for such
• It provides data for a clinical trial as the basis of moving to a point of care advisor to the Dr

We are not participating in the Melbourne trial – it is a large multi site trial not related specifically to what we are doing. Our approach in the US is to use the seminal data set in lung screening the NLST data. Which has longitudinal CT’s and biopsy ground truth.

We used a portion of this data to train the algorithm (along with millions of other studies Enlitic has access to), and the balance as the data to prove the super human predictive power of the tool – which we hope to publish. The aim is reduce false positive and negative rates, and predict malignancy earlier, more accurately and potentially re write the current criteria.

As announced we will open 3 new greenfields clinics in Melbourne this year. They are included in our guidance.

We also intend to acquire clinics in Melbourne this year, which are not in the guidance.

Thanks again @Green56FJ
Champee