Alive and Kicking: Kidney diagnosis house Proteomics divorces its US partner

Proteomics and US partner Sonic Healthcare say ‘I don’t’ and go their separate ways
The company hopes to launch its PromarkerD diagnostic tool in the US in the current financial year
Virtual health IT provider Visionflex VFX has unveiled three “significant” sales agreements, including with the Royal Flying Doctor Service

Life sciences companies tackling the US market generally crave a heavyweight partner to assist their commercialisation efforts, but – as with marriages – such unions don’t always pan out.

In the case of diabetes prognosis house Proteomics International Laboratories (ASX:PIQ), the company has terminated its exclusive US licence agreement with the US arm of Sonic Healthcare (ASX:SHL), the third biggest pathology provider there.

The agreement pertained to the use and commercialisation of Proteomics’ PromarkerD test in the US.

Proteomics says the reason for the separation is that Sonic did not meet milestones and key performance indicators contained in the May 2023 agreement.

At the time, CEO Richard Lipscombe described Sonic as an ideal partner. But how many of us have promised to love and honour at the altar and not exactly followed through?

The ‘divorce’ means Proteomics is now free to launch PromarkerD in the US via licensing to “alternative pathology laboratories and service providers and/or direct to consumer or patient”.

The algorithm-based PromarkerD uses a simple blood test to detect a unique ‘fingerprint’ of the early onset of the disease, by measuring three serum protein biomarkers.

These are combined with three “clinical variables”: age, high-density lipoprotein (HDL) cholesterol levels and the kidneys’ filtering ability.

The algo integrates the results into a patient risk report.

In the US PromarkerD is being used as a lab-developed assay, which means it can be integrated into the standard panels of commercial labs ahead of regulatory approval.

In March this year, Proteomics shares tumbled 30% after the company said it would be unable to meet its June timeline for the US launch of the test.

The company cited the “complexities involved in bringing a new test into broad clinical use.”

The company is now targeting a US launch in the current financial year.

Peer-reviewed studies to date have proved PromarkerD’s chops as an accurate predictive tool for the onset of diabetic kidney disease (DKD) and future kidney function decline, up to four years in advance of symptoms.

DKD is a serious complication arising from diabetes which – if unchecked – can lead to dialysis or kidney transplant.

The studies pertained to patients with the more common type 2 diabetes, which usually develops for lifestyle reasons (a.k.a the wages of sin such as bad diet and obesity).

In August, the company released results of its phase II, 92-patient study on renal decline in type 1 diabetes (the exact cause of this variant is not known, but genetic factors are at play).

We’ll spare you the details of the science, but the preliminary data suggests that PromarkerD is just as good a prognostic test for type 1 diabetes as for type 2 diabetes.

“The additional application for type 1 diabetes patients with their unique clinical needs offers a new target market for PromarkerD,” the company says.

Previous studies showed PromarkerD correctly predicted up to 86% of otherwise healthy diabetics who went on to develop DKD within four years.

The latest results were aired at last month’s Australasian Diabetes Conference in Perth and have been accepted for publication in the journal of Clinical Diabetes and Endocrinology.

In the biotech world, if you haven’t been heard at a prestigious conference or validated in a peer-reviewed journal you’re just camping out.

Visionflex virtual healthcare sales take off

Virtual health IT provider Visionflex (ASX:VFX) has unveiled three “significant” sales agreements, including with the venerable Royal Flying Doctor Service’s Victorian division.

Others are with Kha Loc Medical, a Vietnamese medical equipment distributor and Anglicare (an initial trial across three aged-care sites).

Visionflex combines a hardware and software platform (such as digital stethoscopes) to enable practitioners to examine, diagnose and treat patients in remote locations.

So you can see why it might be highly useful for the flying docs.

The company says the contracts are “significant”, in terms of the expansion opportunities, but not material in their own right.

The company’s clients include Woodside Energy, covering seven offshore platforms and WA Primary Health Alliance covering 180 aged-care facilities.

Visionflex chalked up a 169% increase in revenue for the 12 months to June 30 2024, to $6.95 million. The company also reports annual recurring revenue – the expected proceeds from known contracts – to $1.3 million (up 400%).

The company’s $700,000 ebitda loss improved on the previous $3.2 million deficit.