NEW YORK – Swiss cancer liquid biopsy startup Hedera Dx is hoping to fill an unmet need in the cancer sequencing market, offering hospitals and community oncology providers a blood-based sequencing test and interpretation tool that can be rapidly deployed and easily kept in compliance with evolving regulatory requirements.
Founded in the summer of 2021 and based in Lausanne, the company recently announced that it raised €14 million ($13.9 million) in seed funding, which it is using to support the commercial launch of a testing kit, initially focused on a small set of genes relevant to non-small cell lung cancer.
Tommi Lehtonen, the firm's cofounder and CEO, said that Hedera hasn't finalized the content of its sequencing assay but has already developed the end-to-end software, called Hedera Prime, that will enable a streamlined workflow that it believes can serve more types of customers, especially in the disseminated European market.
"We all know that liquid biopsy is transformational for cancer care [and] there is a lot of investment into it. But being in Europe and being outside the US market, we aligned quickly on the vision that there is a need for an offering that serves the hospital in-house laboratories and resolves hurdles that we identified," Lehtonen said.
Though much attention is being paid these days to liquid biopsy in early cancer detection or screening, these hurdles have limited the implementation and availability of even the most established application: tumor profiling to guide precision oncology care.
"Our vision stretches quite far, but if we just look at even basic NGS in oncology today, there is still limited access," Lehtonen said, adding that "this carries very significant clinical impact and very high magnitude impact for our patients."
Labs do have a diversity of products to choose from for implementing in-house liquid biopsy testing these days, but with some exceptions, most fall into either the category of upfront laboratory equipment — sequencing assays plus required sample preparation and handling technologies — or interpretation and reporting software products.
A lot of attention is paid to developing new assay technologies, Lehtonen said, but less to issues like validation, streamlining, and regulatory compliance.
"What we've seen with customers we're working with developing our offering, there's a whole lot to improve just in these workflows of how to get from sequencing data to therapy selection for the patient," he said.
"If you are an in-house laboratory, you have to go through your own compliance steps and R&D steps with the solutions that are already on the market, and we feel that we will be able to bring a solution where we can really streamline these hurdles for the customer."
The European diagnostics market saw a significant change this year with the implementation of a new In Vitro Diagnostic Regulation system. Lehtonen said the community is still "digesting the changes," which affect the types of tools clinical labs can implement in patient care and how tools are evaluated and registered for clinical use.
"I think what we can be certain of is that this changes the way that people think about compliance. It sets new hurdles," said Lehtonen, who is the former CEO of Blueprint Genetics, a Finnish genetic testing company that was acquired by Quest Diagnostics in 2020.
Ahead of finalizing and disclosing details of its sequencing panel, Hedera is already pioneering the CE-IVD-registered Hedera Prime interpretation and reporting software with early clinical collaborators. One is José Antonio López Guerrero, head of the Laboratory of Molecular Biology at the Valencian Institute of Oncology Foundation in Valencia, Spain.
In an email, López Guerrero echoed Lehtonen's characterization of the hurdles to broader precision oncology access, citing time-intensive laboratory processes and evolving clinical evidence as stumbling blocks he believes technologies like Hedera's could help overcome.
Lehtonen said that Hedera expects to begin rolling out its validated sequencing assay in early 2023 once it has also gained the necessary CE-IVD certification.
Although a growing number of US hospitals and health centers have sought to bring NGS testing, including liquid biopsy assays, in-house in recent years, Lehtonen said that Hedera views the greatest need in European markets, so that is the firm's main focus, at least initially.
The company's new funding will go both toward the commercial launch and to support the first phase of a real-world evidence clinical testing program, which will allow it to create a database reflecting real-world usage of liquid biopsy testing and related cancer patient outcomes.
Christian Meisel, Hedera's chief medical officer, argued that a lack of utility data is also a hurdle to liquid biopsy adoption. "In many countries, there is not broad [use of] liquid biopsy, and a really large dataset will be required to demonstrate and prove the clinical utility, the clinical value, and also maybe the economic value," he said. Data that the company collects through its planned real-world testing program could help drive reimbursement in relevant markets, he added.