CellMax Life's FirstSight CRC Blood Test (DNA), page-15

The product is most certainly a lifesaver, of the very best kind - prevention!

The Directors have reported multiple times that Colostat will be low cost. The best businesses are built on supplying low-cost items on a huge scale whilst outstripping their competitors on every level including quality, accuracy, efficiency, and price. It's the perfect way to disrupt the market. Luckily this particular market is very large.

Adoption of Colostat by the National Bowel Cancer Screening Program DOES NOT require an Act of Parliament! The body is already well structured and empowered, with the aid of advisory bodies, to make decisions on what type of test is to be used (as they have recently by replacing FOBT with FIT).

Here is a review of the NBCSP prepared by Deloittes Sept 2021 -
https://www.health.gov.au/sites/default/files/documents/2022/06/review-of-phase-4-of-the-national-bowel-cancer-screening-program-nbcsp-evaluation-report-review-of-phase-4-of-the-national-bowel-cancer-screening-program.pdf

Of particular interest is this section-

"The efficacy of emerging testing technologies should continue to be monitored.
Although the two-sample iFOBT is currently considered best practice, the suitability of new
technology and diagnostic methods should be reviewed in collaboration with Health Technology
Assessment committees.
For example, emerging evidence shows the sensitivity of liquid biopsies for detecting early stage
bowel cancer may be superior to the iFOBT, with a pilot study currently in progress at the Royal
Marsden Hospital in the United Kingdom.
31 Liquid biopsies aim to detect circulating tumor cell-free
DNA to detect cancer. However, the use of liquid biopsies as a screening technology (as opposed
to its use in diagnosed cancer cases) requires multiple criteria to be met. Firstly, if the test is
designed to detect multiple cancers, it must be able to determine the tissue of origin with
reasonable accuracy, to avoid patients undergoing a series of expensive diagnostic procedures as a
result. The false positive rate would also need to be low to avoid large diagnostic costs, and the
test would be required to perform adequately in asymptomatic populations. Finally, the prospect of
liquid biopsies as a screening tool for multiple cancers may also require a comprehensive costeffectiveness evaluation examining many facets of the Australian health system. This would be due
to the cancer-screening programs already in place for breast, bowel and cervical cancer, alongside
the personalised diagnostic journeys that Australians currently face for other cancers which may
be in scope for the test.
In addition, new simple blood test methods are emerging for groups who are not able to complete
faecal testing easily (e.g. those with benign bleeding, those who are visually impaired and those
with mobility or cognitive issues).32 Diagnostic strategies for these tests include measuring the
concentration of protein biomarkers in order to determine a ‘risk score’ for bowel cancer. However,
these tests are in the early stages of commercialisation and evidence of cost-effectiveness would
rely on the expense of the equipment required to complete testing, as well as the sensitivity and
specificity at detecting disease. Reliable evidence on efficacy is also limited at this stage.
In any decision to transition to a new test type, it is important that the test is approved by the
Therapeutic Goods Administration (as per the guidance in the NBCSP Quality Framework) and a
cost-effectiveness analysis is performed using reliable estimates of test sensitivity and specificity,
as compared with the current iFOBT."

TGA is essential prior to the NBCSP commencing their assessment of Colostat. Given that Colostat ticks each and every box of the above-mentioned criteria (except TGA which is imminent....) I'd say TGA approval is most definitely an extremely significant milestone. Any funds manager worth their salt should see that the potential here is rather huge, to say the least!