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From theory to therapy: Cancer diagnostics

Finding out if you have cancer, through a simple test and even prior to any symptoms, would mean a more curative treatment and a much better prognosis of survival. Sweden has a few solutions with great potential well on their way.

Swedish Elypta, founded in 2017, has made headlines and received several awards for their solutions within this field. The company was recently awarded The Roddenberry Prize for their groundbreaking test for cancer detection. The Prize support audacious early-stage science and tech ventures that contribute to the United Nations Development Goals. Elypta’s metabolism-based test for early cancer detection was honored with the grand prize of 1 million USD.

The company’s method involves measuring a unique panel of metabolites whose composition has been found to be altered in the blood and urine of cancer patients, allowing identification of distinct “signatures” using machine learning.

These signatures, or biomarkers, are exceptionally sensitive and can be identified for a variety of cancers. Their liquid biopsy is evaluated in several ongoing clinical studies, including Multi-Cancer Early Detection (MCED) studies validating the diagnostic performance of GAGomes – the complete profile of human glycosaminoglycans – as metabolic biomarkers for MCED.

 

Francesco Gatto, founder and Chief Scientific Officer, Elypta.

 

Detecting stage I cancer

In December 2022 Elypta announced the results of research conducted at Chalmers University of Technology by Elypta founders Jens Nielsen and Francesco Gatto, showcasing the MCED potential of glycosaminoglycans as biomarkers of tumor metabolism. In this screening-like study, the test detected 43% of future cancers with a lethal outcome and only 1% false positives. The test proved exceptionally sensitive to stage I cancer, doubling the detection rate reported by any genomic biomarkers validated in similar populations. The estimated testing cost was also less than 50 USD, with low sample volumes needed, underlining the potential for widespread use.

In March this year another study showed promising results supporting the use of GAGomes for monitoring and predicting response in patients with metastatic renal cell carcinoma, adding further insights when it comes to the potential of using GAGomes to guide critical medical decisions in cancer.

Systemic biomarkers can detect cancer prior to clinical symptoms that indicate its presence.”

“Systemic biomarkers can detect cancer prior to clinical symptoms that indicate its presence. To provide clinical benefits, such markers need to be highly specific and sensitive across many different cancer types. The complex biology of cancer calls for multiple biomarkers to be combined to optimize performance. The metabolic multi-cancer early detection biomarker results reported today, are an exciting addition to this emerging field. They hold potential to refine the target population for screening and to detect additional cancer types,” said Elypta’s Chief Medical Officer Volker Liebenberg after the news came out.

The company aims to seek regulatory approval in 2025 and, if all goes well, launch thereafter. It has also recently initiated a multi-cancer screening study in the USA together with Vincere Cancer center in Phoenix. “In this study, samples are collected from 2,000 firefighters which already undergo regular health checks and have been shown to have an increased risk of cancer. We want to investigate if our test can help Vincere to identify early cancer cases in these individuals,” says Karl Bergman, CEO of Elypta.

 

The metabolic multi-cancer early detection biomarker results that Elypta has reported hold potential to refine the target population for screening and to detect additional cancer types. Photo of Karl Bergman, CEO, Elypta: Gabriel Liljevall

 

Circulating tumor DNA

Another approach to cancer detection is using circulating tumor DNA (ctDNA). ctDNA is specific to cancer and has a very large dynamic range, from being at absolute zero, which means no detectable cancer, to having levels of many tens of thousands of mutant DNA copies per milliliter of blood. Analysis of ctDNA in liquid biopsies has rapidly becoming one of the most important minimally invasive diagnostic methods used in oncology since it has overcome the many limitations of traditional diagnostic methods used today. Treatment decisions will rely more and more on the genetic variant profile of a tumor derived from the patient’s cancer cells. Thus, liquid biopsy tests that can capture and analyze tumor cells and/or circulating tumor DNA hold great promise for current and future cancer applications.

The cost of our method is also generally considerably lower, which becomes important if you want to reach a wider population.”

When explaining why the company uses metabolites and not, ctDNA Karl Bergman explains that when tumors are small, they release very little DNA into the blood, which for many types of cancer limits sensitivity in early stages.

“In our proof-of-concept studies, we have been able to demonstrate a clear improvement here when we measure over 14 types of cancer. The cost of our method is also generally considerably lower, which becomes important if you want to reach a wider population. However, we are sure that ctDNA is here to stay of course and see that we have a good complementarity,” he says.

The future of cancer diagnostics

When it comes to cancer diagnostics Bergman says that the regulations have become stricter in the EU which means that the requirements for extensive studies are increasing. At the same time, reimbursement for diagnostics is historically quite low compared to pharmaceuticals, which places high demands on the ability to cost-effectively take a marker from discovery to market and finance that journey, he explains.

“At the same time, there is a broader trend and demand for preventive measures and early detection, so we believe that the conditions will improve over time,” concludes Karl Bergman.

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