NEW YORK – Immunohistochemistry firm Lunaphore has shifted from its initial emphasis on IHC-based diagnostics to the fast-growing spatial biology space.
Since releasing its high-plex protein imaging system Comet earlier this year, the Lausanne, Switzerland-based company, a spinout from the Swiss Federal Institute of Technology Lausanne (EPFL), has placed instruments in several high-profile laboratories and medical centers around the world and is carving out a place for its technology in spatial proteomics and immuno-oncology research.
At the core of Lunaphore's technology is the use of microfluidics to more quickly and reproducibly deliver staining reagents to tissue samples for IHC assays. In 2019, the company launched its first product, a microfluidics device called LabSat, that allowed researchers to perform rapid IHC staining. The same year, the device received the CE-IVD mark, and Lunaphore began marketing it as a tool for more quickly assessing surgical margins during cancer surgery.
During the COVID-19 pandemic, however, the company decided to refocus its efforts, concentrating on the research market and the development of the Comet system, which uses the same underlying microfluidics technology to stain as many as 40 proteins per sample, significantly more than the LabSat system, which tops out at 10.
"We decided to really focus on the researcher market because it was where we were seeing more traction," said Déborah Heintze, Lunaphore's cofounder and chief marketing officer, noting that the company does not currently offer either system for the clinical market.
Comet "was something that we had been cooking for some time on the side as a research project," Heintze said. But as the company saw increased use of fluorescence imaging in pathology and higher and higher multiplexing in spatial biology experiments, it decided to make the platform its core focus, she added.
The Comet platform stains proteins of interest in an iterative fashion, two at a time, then images those proteins, washes the sample, and stains the next pair. The system is automated, allowing for the workflow to proceed without human intervention. The company's microfluidics technology also reduces the antibody incubation time, improving throughput, Heintze said.
The instrument can analyze around 16 samples, each 9 mm by 9 mm, per week at a plexing level of 40 proteins per sample, though Heintze said Lunaphore is in the process of expanding the size of tissue samples the system can analyze.
The company is entering an increasingly crowded market, with companies including Akoya Biosciences, Standard BioTools, Ionpath, Bruker, NanoString Technologies, and NeoGenomics all offering platforms for more highly multiplexed spatial proteomics. Heintze said Lunaphore believes one key competitive advantage for the Comet system is the fact that it uses conventional antibodies, without the need for any kind of conjugation or barcoding to enable readout.
"Just in terms of onboarding the technology, it is much quicker," Heintze said. "People who have been using their own reagents can just put them on the machine. Many of our customers have been able to develop their own 10, 20, 30-plex assays in a matter of a week or two weeks. So from that perspective, we have this different approach that brings a solution that simplifies spatial biology as much as possible."
The Comet system became available around the beginning of the year, though it is currently being offered through what Heintze called a "priority access" program. Lunaphore is planning a broad commercial release of an updated version of the system next year that will feature certain usability enhancements along with preset research panels. The company has placed instruments with several major research centers, including Stockholm’s SciLifeLab, Massachusetts General Hospital, and the contract research organization Propath UK.
It has also inked deals with AI-based image analysis firms to provide software tools for use with the system. Last month, Lunaphore announced a partnership with Hoersholm, Denmark-based Visiopharm through which the companies will comarket the Comet system with Visiopharm’s Oncotopix Discovery deep learning software. It also signed a comarketing agreement with Albuquerque, New Mexico-based Indica Labs to offer the Comet system with Indica's Halo and Halo AI digital pathology image analysis software.
Markus Herrmann, director of computational pathology at MGH and an assistant professor of pathology at Harvard Medical School, is using the Comet platform to research spatial proteomic profiles that could help predict response to PARP inhibitor therapy in ovarian, breast, and prostate cancers.
He noted that while much spatial omics work has focused on immuno-oncology, "there are other problems that don't receive as much attention at the moment, but which are still relevant."
"PARP inhibitor treatment is one of these examples, where we have an underlying theory of how they operate, but we don't really have good clinical assays to test whether a patient would actually benefit from treatment or not," he said.
Herrmann was familiar with Lunaphore from his doctoral work at the University of Zurich, where he worked on some of the imaging technologies underpinning the company's platforms and collaborated with the EPFL laboratory that ultimately spun out Lunaphore. He said he has no financial stake in the company.
While much spatial proteomics immuno-oncology research has focused on using cell surface markers to identify populations of immune cells of interest, he said, he and his colleagues aim to focus more on functional markers like proteins involved in DNA damage pathways that PARP inhibitors target.
This, he said, could prove more challenging given that these targets are not as well understood as the cell surface markers used to subtype immune cells, and that many of them may feature important post-translational modifications that could be lost during the tissue fixing process.
Additionally, "finding antibodies that will work reliably in formalin-fixed paraffin-embedded tissue to measure the activity of those proteins is challenging," he said. "There’s more [assay] development necessary to get a good functional readout about the extent of DNA damage and the activity of the DNA repair machinery."
Herrmann said he aims, ultimately, to use the Comet platform to develop a clinical assay for predicting response to PARP inhibitors.