New spin-out launches technology to revolutionize hormone disorder diagnosis

The University of Birmingham and Imperial College London have announced the launch of Intelligent Mass Spec Solutions Ltd (IMS Solutions), a new spin-out that is set to revolutionize diagnosis of conditions featuring disordered steroid hormone metabolism.

Steroid hormones orchestrate many of the body's fundamental processes, including stress responses, metabolism, energy use, blood pressure regulation, reproduction and fertility. Consequently, conditions where steroid hormone synthesis or metabolism are disrupted often present with diffuse and diverse symptoms, making them difficult, time-consuming and costly to diagnose. 

IMS Solutions' platform technology overcomes this diagnostic challenge by detecting unique steroid signatures in urine and blood.

IMS Solutions launches with a £1.1 million Seed round led by Midlands Mindforge alongside a syndicate including SFC Capital, the UK's Innovation and Seed Capital Fund (UKI2S - managed by Future Planet Capital), NG Bio, British Business Bank and private investors. The company is further supported by a £2.1 million grant from the National Institute for Health and Care Research (NIHR) awarded to Imperial College London.

The funding will enable the company to refine, advance and launch a urine test for the early diagnosis of the rare and difficult to treat cancer Adrenocortical Carcinoma (ACC) in the UK by 2029, and develop the world's first stratification test for Polyendocrine Metabolic Ovarian Syndrome (PMOS), the most common hormone disorder in women, which globally affects 10-15% of the female population. 

IMS Solutions is launching with a strong commercial and scientific team, and a well-advanced roadmap for products that align with current demands from patients, clinicians and healthcare providers."

Dr. Martin Whitaker, CEO of IMS Solutions 

Priya Reddy, Investor, Midlands Mindforge said: "Women's health conditions such as PMOS have historically been significantly underfunded and underserved, despite affecting millions of women globally. IMS has the potential to change that by enabling faster, more accurate route to diagnosis and, ultimately, better patient outcomes. We are incredibly excited to be leading this investment and supporting the IMS team as they bring this important technology to market."

IMS Solutions is a joint spin-out from the University of Birmingham and Imperial, who have provided background patent and know-how intellectual property exclusively to the company.

The technology platform was initially developed at the University of Birmingham by Professor Wiebke Arlt, who is Chief Scientific Officer at IMS Solutions. Professor Arlt, a renowned expert in steroid endocrinology, is Director of the MRC Laboratory of Medical Sciences (LMS), where she leads the Steroids & Metabolism research group, and Head of Department at the Institute of Clinical Sciences at Imperial College London. She also serves as the first female President of the European Society of Endocrinology.

Realizing the opportunity

The first product to market will be a urine test that can discriminate between benign and malignant adrenal tumors, which are found in 5% of people undergoing a scan of the chest or abdomen. The ACCelerate™ test rapidly identifies patients requiring surgery for Adrenocortical Carcinoma (ACC) and reduces the need for surgery in patients whose adrenal tumours are eventually found to be benign.

The NIHR Invention for Innovation (i4i) Product Development Award will support Professor Arlt's ongoing research at the LMS at Imperial's Hammersmith Hospital Campus. The award will enable the regulatory certification and commercialization of ACCelerate™, which consists of a unique panel of biomarkers and a machine learning algorithm trained on a retrospective data set to detect a malignant steroid fingerprint. The algorithm has already been validated prospectively in a multi-center study that showed the test is up to four times more accurate than scans alone. 

Professor Arlt said: "We validated the test through the largest ever adrenal cancer study, which involved over 2,000 patients from 11 countries, and this proved the test's accuracy. The funding means we can now optimize the test and certify to current regulatory standards. In addition, we intend to show that it is also good value for money and can be reliably performed in existing NHS laboratories, without new machines or additional costs."

Unmet needs in PMOS

Polyendocrine metabolic ovarian syndrome (PMOS), formerly known as PCOS or Polycystic Ovary Syndrome, affects much more than the ovaries. It involves multiple hormones, affects how the body processes food and energy, and comes with a significantly raised risk of long-term health conditions such as type 2 diabetes, hypertension, and fatty liver disease. This complex picture is representative of the challenges in diagnosing and treating steroid hormone related conditions and their potential for poor patient outcomes, something IMS Solutions is working to solve.

Although 10-15% of women are affected by PMOS, according to the World Health Organization, up to 70% of these are undiagnosed. There is no single test for PMOS. Diagnosis relies on matching the patient's combination of symptoms, laboratory findings, and imaging to a set of criteria (known as the Rotterdam criteria). 

The test in development by IMS Solutions is a combination of a blood test measuring biomarkers and a unique machine learning algorithm. The test is designed for use in primary care, to stratify PMOS patients for treatment and/or improved management of the condition. Following a successful proof-of-concept study a clinical validation study is in progress. The results are expected to be announced shortly, and publication is anticipated in the next six months.

Professor Arlt said: "We now know that PMOS is not a single disorder but that there are different PMOS subgroups, and some more than others increase the risk of metabolic diseases such as type 2 diabetes, hypertension and cardiovascular disease. The test we are developing will be able to discern which category patients are in, and identify health risks for an individual patient, enabling earlier and improved treatment options."