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Lunaphore Preparing Commercial Launch of IHC Microfluidic to Speed Surgery Decisions


NEW YORK (360Dx) – Swiss startup Lunaphore Technologies is preparing to launch its first product in Europe this summer — a microfluidic device that could enable surgeons to quickly make important intraoperative decisions for their cancer patients.

At the end of last year, the developer of next-generation tissue strainers launched its first product, a microfluidic instrument named LabSat, for use by scientists doing cancer research. This summer, the Lausanne-based startup, a spinout from the Swiss Federal Institute of Technology, anticipates launching the same microfluidic device as an in vitro diagnostic tool for analyzing tissue biopsies during surgeries in European hospitals.

"In this niche application, the tissue diagnosis can be done in less than 15 minutes," far faster than is currently possible during surgery, Diego Dupouy, the firm's chief technology officer, said in an interview.

The microfluidic instrument augments immunohistochemistry staining, a technique that involves the use of antibodies to detect the presence of specific cancer biomarkers on a tissue sample.

IHC is among the most frequent biomarker tests in routine cancer diagnostics following a biopsy, and it is often used in immune-oncology research. During IHC testing, clinicians stain a sample with labeled antibodies that produce tissue colors visible through a microscope on a glass slide. Clinicians and researchers interpret the color markers in their investigations of cancers.

Lunapore's LabSat microfluidic instrument sits on the microscope glass slide, forming a thin reaction chamber that allows a clinician to deliver and wash reagents in a controlled manner, reducing the time it takes to perform a diagnosis, Dupouy said.

"When our microfluidic chip is applied to do the test, we have better control over reagent start and stop times and of the process of depositing and delivering reagents on top of the tissue," allowing users to decrease incubation time and total time to result, he said. During surgery, he noted, current testing can take a minimum of four hours to return a result, far longer than is needed by surgeons.

Anne-Laure Leblond, a scientist working in the pathology department at the University of Zurich University Hospital and a user of the LabStat platform, said that from a user perspective one of the main benefits of the Lunaphore instrument is that it enables a pathologist "to save as much time as possible."

That applies to its intraoperative use and implementation to conduct advanced cancer research, she said.

An unmet need exists, she noted, for a diagnostic tool that enables surgeons to make decisions in the operating room that are actionable. Further, after surgery has been completed, pathologists often need to provide a more extensive investigation of a tumor. There again, they need to provide information as quickly as possible, so that a patient can have a diagnosis and the clinician can begin treatment as soon as possible, she said.

Leblond said that she has found the Lunaphore microfluidic tool to be compact, reliable, easy to use, and free of bubbles that had become a problem with previous attempts to implement a microfluidic prototype that had impaired the flow of reagents used to reveal biological markers.

Inside and outside the operating room, the Lunaphore instrument can also be used to save tissue, she noted, adding that the amount of tissue taken from the body should be minimal and yet provide as much information as possible.

Leblond is looking to combine the IHC data obtained using the Lunaphore LabSat microfluidic device with molecular information that sheds light on the mutational status of tumors. She and her colleagues have had a study accepted for publication in the American Journal of Clinical Pathology, in which they combined immunohistochemistry using Lunaphore’s device with next-generation DNA sequencing for cancer diagnostics.

IVD launch

While Leblond is planning her next research project using its technology, Lunaphore is readying a commercial launch this summer for its microfluidic instrument along with associated reagents. The firm will target sales of its IVD kit for intraoperative applications to European hospitals.

The company received CE marking for LabSat at the end of last year, enabling its marketing in European countries and other countries that accept the designation. Dupouy noted that its staff is currently engaging with distributors to expand its network in Europe.

In the US, the instrument will be made available first as a research tool and next year, subject to obtaining 510(k) clearance, Lunaphore will launch it for intraoperative use as an in vitro diagnostic device.

As an entry level product, the instrument enables processing of one slide at a time, and the firm is deliberately targeting applications that require low capacity but a fast time to result. In research applications, the instrument enables scientists to more quickly optimize assays and increase productivity, the firm said.

Lunaphore does not publicly disclose the price of its instrument.

The company is also developing a next-generation instrument with up to six reaction chambers that will allow more high-throughput testing, and in a separate development project, it is looking to integrate its current technology with slide imaging capabilities.

It anticipates launching the two next-generation products in its development pipeline within the US and Europe during 2021.

Last summer, Lunaphore announced that it had begun partnering with Seville, Spain-based Vitro to develop in situ hybridization protocols for RNA and DNA targets in tissue, and last September, the Swiss startup announced a strategic partnership with A. Menarini Diagnostics to bring a new system to market that uses its LabSat automated tissue staining system.

Lunaphore was founded in 2014 as a spinoff from EPFL, the Swiss Federal Institute of Technology, and is leveraging research conducted at EPFL by its three cofounders — Dupouy; Ata Tuna Ciftlik, its CEO; and Déborah Heintze, its chief operating officer.

In its first year, the firm used research grant funding, but since then it has been funded by Swiss and international venture capital investors.

Thus far, the company has raised around $17 million and while it is well funded, the firm anticipates initiating a funding round before the end of the third quarter of this year for an undisclosed amount, Dupouy said. Lunaphore will use the money to increase market access and product diversification, he said, adding, "In general, we are strategically interested in commercializing IVDs, and we are developing applications that are hot topics in research and eventually will become available in IVD settings."

In a research project that he believes could generate broad interest among clinicians and researchers, Dupouy is working with Stockholm University to develop in situ next-generation sequencing of strands of RNA tissue that would enable molecular analysis and diagnosis.

In one of two studies published last month in Scientific Reports, Dupouy, his colleagues at Lunaphore, and researchers at Stockholm University described an approach to automated generation and sequencing of barcoded mRNA amplicons in situ.

They operated directly on fixed cells by adapting a microfluidic tool compatible with standard microscope slides and cover glasses. Such an automated microfluidic tissue processor for in situ sequencing studies could enhance its research potential, especially for cancer diagnostics, and enable rapid and effective therapies, the researchers reported.

In the second study published last month, Dupouy and his colleagues described the use of its microfluidic tissue processor to conduct automated immunofluorescent multistaining. They reported using the automated processor to demonstrate a four-plex automated multistaining process with clinically relevant biomarkers within 84 minutes.

The researchers noted that in clinical practice, IHC is expected to deliver greater precision in molecular subtyping of cancers because a higher number of biomarker tests can enable a more precise diagnosis and greater treatment success.

Their automated multi-staining approach, with a turn-around time shorter than existing monoplex immunohistochemistry methods, has the potential to enable multistaining without disturbing the current laboratory workflow, they said in their research paper.

Meanwhile, in her ongoing work using the Lunaphore instrument, Leblond is looking to initiate a study to investigate whether DNA is better preserved when tissue is stained using the microfluidic technology.