Interesting read in relation to Protonomics with their announcement today indicating further scientific success with their PromarkerEndo for endometriosis: “……. achieved excellent diagnostic performance across earlier disease stages and a near perfect accuracy in distinguishing severe endometriosis from symptomatic controls”. As laoshi noted the share price went up some 20% today on this announcement.

I have not seen a satisfactory explanation (qualification: explanation enough that would encourage Scoonie to invest in PIQ) as to why their agreement for the Promarker D test for Diabetic Kidney Disease with Sonic in the US did not progress.  An exclusive licence for Sonic to distribute in the US was signed on the 10/5/23 - and then dropped by Sonic 16 months later.   

The ASX listed Sonic is number 3 in the US pathology market. So you would think would be a great fit for PIQ to market its tests.  The arrangement with Sonic was ultimately terminated and at the time of the announcement on the 11/9/24 PIQ stated the following:  “PIQ is now free to launch PromarkerD in the US via licensing to alternative pathology laboratories and service providers and/or direct to consumer/ patient (DTC/DTP)”.    From an outsider perspective it looks like a case of forsaking the substance to embrace the shadow.

Previously PIQ announced on the 10/5/23 an extension with Apacor to continue the exclusive distributorship of Promarker D in Great Britain, stating: “ Both parties are now workings towards the inclusion of PromarkerD in the NICE Guidelines and engaging with the NHS Supply Chain Tender process as part of the commercial roll-out of the test in the UK”.

Also on the 20/12/23 PIQ signed a licence agreement with a company called Omics to sell the Promarker D in Chile with: “Omics now targeting other markets in Central and South America.”

In the Sept 24 quarterly PIQ had unattributed revenues of just $253k.

Other ASX listed firms in the blood/body fluid cancer diagnostic market have met with little commercial or share price success. These include:

1) Rhythm Biosciences (ASX:RHY) – bowel cancer detection test  

Listed in December 17 at 20 cents, reached $1.80 in late 2021 and now shares at around 8 cents.

2) Bcal Diagnostics (ASX: ) -Breast cancer detection test.  

Listed in July 2021 for 20 cents now selling for around 9 cents.  

3) Pacific Edge (ASX: PEB) – Bladder cancer diagnostics

Listed in Sept 2021 at $1.50 now selling 14 cents.

The only company in this market that seems to have done much good from a share price perspective is Cleo Diagnostics (ASX:COV). They have an ovarian cancer test with US clinical trials underway and a FDA submission planned for CY25. COV listed in late 23 at 20 cents and are now selling for 36 cents.

With all these cancer diagnostics no one denies the need for the tests and all the above companies talk up the obviously huge size of their respective potential cancer diagnosis market/s.  Some of the company slide decks are crammed with information on the poor specificity/sensitivity of current tests (if they exist), or tell how awkward current tests are to perform, however seem to have much less detail about their own tests.

All 4 of the above have and are currently mightily struggling to get their tests to commercialisation.  I don’t want to take away from what these great Aussie scientists (and Kiwi in the case of PEB) have achieved - and Biotech is hard. However maybe there is a Strawman medical insider out there who can shed some light on just why this on this little corner of the ASX listed biotech space looks like Shipwreck Central. 

I agree with your sentiments @ Bradbury, in relation to Proteomics (ASX:PIQ) having discontinued their agreement with Sonic Healthcare to sell in the US PIQ’s Diabetic Kidney Disease diagnosis test PromarkerD. 

This appeared to be a potentially a very successful test and a lucrative relationship with Sonic. The test could predict up to four years in advance, the likelihood of a diabetic patient developing the debilitating Diabetic Kidney Disease. What’s more there are drugs and actions available to the patient to prevent the onset of the disease, if detected early. In addition PIQ have obtained US Medicare reimbursement for the test.   A real winner you might think.

In May 2023 PIQ licenced the same test to Omic Global Solutions (OGS) for sale in Puerto Rico. Well, you have got to start somewhere. This was later extended to Chile in December 23. PIQ has not specifically reported or broken out just what the sales of the test by OGS have been to date. You could only surmise, not much.

This is unlike Botanica (BOT) where for their FDA approved drug Sofdra used for the treatment of hyperhidrosis, you can get a sense of how successful the US rollout might be. This is because they have been selling the same drug in Japan since late 2020.  BOT recently indicated 350,000 units of the drug being sold last year in Japan. Whilst the figure is somewhat opaque since you are not getting specifics on patient persistence and the like, it is at least something and helps engenders investor confidence in BOT.  You do not have to capture much of the US market for BOT to be very successful.

As another counterpoint to PIQ, the ASX listed Microbia (MAP) have a relationship with Sonic Healthcare to sell their gut health test kits in Australia, USA, UK and elsewhere. In November 2022 Sonic took at 19.9% interest in MAP. So Sonic are not adverse to partnering and taking ownership stakes in allied health testing companies they believe have promise.  

There are two other companies with roughly similar-in-intent tests that come time mind:

i)  Rhythm Biosciences (ASX:RHY) with a bowel cancer detection system using bloods samples,

ii) Pacific Edge (ASX:PEB) has a genomic test that analyses biomarker genes to help rule out bladder cancer. Testing is via a urine sample.

Both have seen their market caps decimated by over 90% from their respective highs as the initial optimism waned when the reality of commercialisation sunk in. You could probably add in BCAL Diagnostics (ASX:BDX) with their breast cancer detection via a blood test to the list, on the basis for now the market remains (overly) optimistic on their prospects. Maybe Chair and founder Jayne Shaw being a first rate networker and promoter could have something to do with this. 

Commercialisation of these type of tests has proved very difficult and what Australian investors are typically seeing is only the ASX listed companies of this type. There is a whole world of biotech companies working in this field, a very competitive area.    

PIQ in its ASX release of the 11/09/24 indicating they no longer will have any commercial relationship with Sonic and said: “Proteomics International is now free to launch PromarkerD in the US via licensing to alternative pathology laboratories and service providers and/or direct to consumer/ patient (DTC/DTP)”.   Right, let’s cease dating Taylor Swift and go check out the old people’s home. 

Whilst PIQ’s PromarkerD test is promising and the upcoming test for endometriosis looks very positive, however given their recent record it is difficult to get any sort of a woody over PIQ. (Apologies for the usage of highly technical finance terminology).