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Polygenic Risk Score Firm Antegenes Aims to Invest in International Expansion, R&D

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NEW YORK — Antegenes said this week that it has raised €2.3 million ($2.3 million) in seed financing and government grants. According to CEO Peeter Padrik, the new funds will allow it to enter new markets in Europe and to invest in its pipeline of polygenic risk score-based tests.

Founded in 2018 and based in Tartu, Estonia, Antegenes already serves its home market and is present in the UK via a partnership with Everything Genetic, a British genetic testing company based in Nantwich, about an hour south of Liverpool. But the company is poised to enter markets in Sweden, Norway, Portugal, and Spain, and is working toward a launch in Germany.

Antegenes' current offering consists of four tests that use polygenic risk scores to assess a patient's risk for developing breast cancer, colorectal cancer, prostate cancer, and melanoma. All four tests — branded as AnteBC, AnteCRC, AntePC, and AnteMEL — carry CE-IVD marks that are valid through May 2026, as the EU transitions to its new In Vitro Diagnostic Regulation.

The assays were developed using data from the Estonian Biobank and the UK Biobank. They are run using a custom genotyping microarray, though the company also accepts uploads of genotyping data obtained from consumer genomics services, such as Ancestry or 23andMe. The tests are available on the company's website for €195, though those who already have their data pay less. Antegenes also offers pre- and post-test genetic counseling and oncology consultations via a telemedicine platform.

Antegenes uses genotyping data, Padrik noted, because most biorepositories have their samples genotyped on array platforms, plus the cost of offering an array-based test is less than the cost of sequencing. That said, the company can also accept patient sequencing data.

The firm is now keen to make its tests available in more markets around Europe while investing in new tests to build out its menu, with products for cardiovascular disease risk and type 2 diabetes risk in development. Padrik confirmed that the company would use part of the proceeds of its financing, raised in part from numerous private investors, to scale up its sales and marketing team, while also building out its research and development team to support these endeavors.

At the same time, the firm is relying on two government-funded projects as a vehicle for making its tests available in several markets. One of these is called Be Right with Cancer Management (BRIGHT) and is supported via EIT Health, an EU organization that supports healthcare innovation. That project commenced in January and has a total budget of €2.3 million, €500,000 of which will support Antegenes' participation. It involves trialing the company's AnteBC test at sites in Estonia, Sweden, and Portugal, with one of its aims to collect data to support an IVDR submission. BRIGHT will wrap up in 2025.

According to Padrik, partners on the BRIGHT project include the North Lisbon University Hospital Center in Portugal, IESE Business School in Spain, Region Uppsala in Sweden, GE Healthcare in Hungary, and the University of Tartu, Tartu University Hospital, and Estonian Health Insurance Fund. The partners aim to determine the best ways to implement polygenic risk scores into breast cancer screening programs, including how to organize the process of testing women and how to advise on healthcare after testing is complete.

"Currently, breast cancer screening starts in most countries at age 50, but many women have a significantly higher risk already in their 30s," said Padrik. "Using our tests, it's possible to identify those who are at a higher risk and give them recommendations to start screening at earlier ages."

Padrik noted that such an approach has already been implemented in Estonia, where those who receive information about a potential higher risk for breast cancer via Antegenes' AnteBC test can get their routine screening costs covered by Haigekassa, the Estonian Health Insurance Fund.

A second project that will see the AnteBC test implemented in a clinical setting is AnteNOR. The effort is funded via the Norway Grants Green ICT Program, which supports Estonian-Norwegian partnerships in the fields of green industry innovation, welfare, and ICT.

AnteNOR has a budget of €1.5 million and commenced in July 2021, with an end date in April 2024. It involves multiple Norwegian clinical partners, including the Oslo Cancer Cluster, Oslo University Hospital, the Vestre Viken Hospital Trust, and Oslo University.

The goal of AnteNOR is to implement AnteBC as part of routine breast cancer screening in Norway. The consortium will assess the test's performance in Norwegian patients and will gather the data and documents necessary to prepare it for reimbursement through the Norwegian National Insurance Scheme.

Ketil Widerberg, general manager of the Oslo Cancer Cluster, said via email that the oncology research and industry cluster is interested in adopting new cancer diagnostics and treatments and believes that genetic tests such as AnteBC are "part of the future of cancer prevention." He said the cluster, which has more than 90 member organizations, is "keen to find out if this personalized screening approach can help identify breast cancer patients at an earlier stage and hopefully save lives."

According to Widerberg, AnteBC could become a complementary approach in screening programs, as it is able to identify women at advanced risk before they reach age 50, when they are eligible for Norway's breast cancer screening programs. "We are currently seeing a revolution in cancer diagnostics, treatments, and care," commented Widerberg. "Identifying breast cancer early by using genetic tests is part of this revolution."

According to Padrik, Antegenes will consider both projects to be a success if breast cancer screening is organized differently after the BRIGHT and AnteNOR projects.

"The aim is that genetic information, including polygenic risk score tests, are used for risk estimations of women, and that breast cancer prevention is organized according to personalized risk levels," said Padrik. "Of course, our vision is that our genetic tests are used for these precision prevention programs and not only for breast cancer but also for colorectal cancer and prostate cancer."

Antegenes is eager to enter the German market, as well. Last month, the company joined the Medical Forge Leipzig accelerator program, which helps companies bring their healthcare offerings to the German market. Antegenes is currently creating a network of business and academic partners as well as healthcare payors to launch its tests in Germany, Padrik said.

Ultimately, of course, the market is everybody. Padrik noted that Antegenes is looking at the US market, as well, and is in the process of creating a strategy for entering it.

"In the future, potentially all individuals would have their genetic risk estimated, evaluated, and should have personalized precision prevention programs and activities," said Padrik.

"This helps to reduce cancer mortality and morbidity."

There are other companies out to conquer the same market, though. Genomics PLC, an Oxford, UK-based company, said in January that it had partnered with the UK's National Health Service to pilot how adding polygenic risk score data to conventional risk assessments might help prevent cardiovascular disease. Allelica, an Italian company based in Rome, with offices in New York and London, said in May that it had partnered with Invitae to develop a polygenic risk score for breast cancer that could be used for people of diverse ancestries.

Padrik said the presence of Genomics PLC and Allelica, among others, showed that there is increasing demand for polygenic risk score tests. "If there is no competition, then there is no market," said Padrik. "We think that having competitors is good. Together, we are creating a whole field of genomic-based personalized prevention."

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