New spin-out IMS Solutions to commercialize groundbreaking ‘steroid fingerprint’ technology

Intelligent Mass Spec Solutions Ltd (IMS Solutions), a new spin-out from the University of Birmingham and Imperial College London, is developing a diagnostic platform that detects unique steroid signatures in urine and blood. The company says its first planned product is a urine test intended to distinguish benign adrenal tumours from adrenocortical carcinoma, while a second blood-based test is being designed to stratify women with polyendocrine metabolic ovarian syndrome for treatment or improved management. The announcement describes a commercial development programme in which regulatory certification, further optimisation and additional validation are still ahead for parts of the work, rather than an already available diagnostic service.

The platform was initially developed at the University of Birmingham by Professor Wiebke Arlt, who is chief scientific officer at IMS Solutions and leads the Steroids & Metabolism research group at Imperial College London’s MRC Laboratory of Medical Sciences. The two universities have provided background patent and know-how intellectual property exclusively to the company. Its proposed tests combine measurements of steroid-related biomarkers with a machine-learning algorithm designed to identify molecular patterns associated with different conditions.

In the adrenal-cancer programme, the proposed ACCelerate™ test uses a panel of biomarkers and an algorithm trained on a retrospective data set to detect what the company describes as a malignant steroid fingerprint. According to the announcement, ACCelerate has already been validated prospectively in a multicentre study that Professor Arlt described as the largest adrenal-cancer study conducted. The study involved more than 2,000 patients from 11 countries, and the investigators reported that the test was up to four times more accurate than scans alone.

That comparison describes performance reported in the studied population; it does not establish that the same result will be obtained for every patient or healthcare setting. The next stage described for the test is optimisation, regulatory certification and assessment of whether it can be performed reliably in existing NHS laboratories without new machines or additional costs. IMS Solutions launched with a £1.1 million seed round led by Midlands Mindforge, with a syndicate that included SFC Capital, the UK’s Innovation and Seed Capital Fund, known as UKI2S and managed by Future Planet Capital, NG Bio, the British Business Bank and private investors.

Imperial College London also received a £2.1 million grant from the National Institute for Health and Care Research under its Invention for Innovation Product Development Award scheme. The company says the funding will enable it to refine, advance and launch a urine test for the early diagnosis of adrenocortical carcinoma in the United Kingdom by 2029. It also says it will develop what it describes as the world’s first stratification test for polyendocrine metabolic ovarian syndrome.

Adrenal tumours are found in 5% of people undergoing a scan of the chest or abdomen, according to the release. The proposed ACCelerate test is intended to address the uncertainty that can follow when an adrenal tumour is detected incidentally. The announcement says the test rapidly identifies patients requiring surgery for adrenocortical carcinoma and reduces the need for surgery in patients whose adrenal tumours are eventually found to be benign.

These are stated aims of the test rather than completed real-world outcome results. A prospective diagnostic study can address accuracy, but the release does not provide the study’s full methods, confidence intervals or evidence that the test will reduce surgical procedures or improve patient outcomes in routine NHS care. Professor Arlt said the funding would allow the team to optimise ACCelerate and certify it to current regulatory standards.

She also said the study data had demonstrated the test’s accuracy, while noting that the next phase would examine whether the test is good value for money and can be reliably performed in existing NHS laboratories without new machines or additional costs. The project therefore has several distinct stages: the reported multicentre validation, further optimisation, regulatory certification, and economic and implementation work. Performance in a research cohort, even when reported as substantially better than scans alone, does not by itself establish regulatory approval, cost-effectiveness or consistent performance across laboratories.

IMS Solutions is also developing what it describes as the first stratification test for polyendocrine metabolic ovarian syndrome, formerly known as polycystic ovary syndrome. The release states that the condition affects 10–15% of women globally and cites the World Health Organization as reporting that up to 70% of affected women are undiagnosed. PMOS involves multiple hormones, affects how the body processes food and energy, and is associated with a significantly raised risk of long-term conditions such as type 2 diabetes, hypertension and fatty liver disease.

Because there is no single test for PMOS, diagnosis currently relies on matching a patient’s combination of symptoms, laboratory findings and imaging to the Rotterdam criteria. The proposed PMOS test is intended to be different from a straightforward yes-or-no diagnostic. It combines a blood test measuring biomarkers with a unique machine-learning algorithm and is designed for use in primary care.

The stated purpose is to stratify people who have PMOS into subgroups that may have different risks of metabolic disease and related health problems, so that treatment or management can be improved. Professor Arlt said the work had identified different PMOS subgroups and that some groups increase the risk of conditions such as type 2 diabetes, hypertension and cardiovascular disease. The release presents the test as a tool for differentiating clinically relevant risk categories, but the clinical validation study described in the announcement is still in progress.

The company said a successful proof-of-concept study had been completed and that a clinical validation study was under way. Results were expected shortly, with publication anticipated within the next six months. The announcement did not provide accuracy estimates, participant numbers, endpoints, subgroup definitions or peer-reviewed results for that study.

Consequently, the available evidence does not establish how accurately the proposed test assigns PMOS subgroups, whether those assignments are reproducible, or whether the categories correspond to differences in outcomes or treatment response. The proof-of-concept result reported in the release supports continued development, but it is not equivalent to a completed clinical validation of the intended primary-care use. The wider rationale is that steroid hormones participate in many of the body’s fundamental processes, including stress responses, metabolism, energy use, blood-pressure regulation, reproduction and fertility.

The announcement says disorders of steroid hormone synthesis or metabolism can produce diffuse and varied symptoms, making them difficult, time-consuming and costly to diagnose. IMS Solutions’ platform is intended to detect unique steroid signatures in urine and blood, using combinations of biomarkers and computational analysis rather than a single hormone measurement. The approach remains at different stages for its two lead products: ACCelerate has completed a large prospective validation effort but still requires optimisation, certification and further implementation assessment, while the PMOS stratification test is in clinical validation with results pending.

The spin-out thus represents a translational pipeline built on university research, not a pair of already approved tests, and its eventual diagnostic role will depend on the evidence produced in the remaining development stages.

Subject of Research: Steroid-biomarker diagnostics for adrenocortical carcinoma and polyendocrine metabolic ovarian syndrome

Article Title: New spin-out IMS Solutions to commercialize groundbreaking ‘steroid fingerprint’ technology

Article References: New spin-out IMS Solutions to commercialize groundbreaking ‘steroid fingerprint’ technology. Original publication (Bibliographic details unavailable.)

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Keywords: IMS Solutions, steroid fingerprints, adrenocortical carcinoma, adrenal tumours, polyendocrine metabolic ovarian syndrome, polycystic ovary syndrome, mass spectrometry, machine learning, biomarkers, clinical validation, women's health, spin-out