NEW YORK (360Dx) – A recent €1 million ($1.1 million) grant could push French diagnostics firm Metafora Biosystems into a new and potentially lucrative market: cancer testing.
The company was awarded the €1 million grant recently from Bpifrance, a French investment bank, as part of the French government's Innovation Challenge initiative, in which Bpifrance has participated. The initiative supports BMEs and startups with innovative projects, and Metafora plans on using the funds to develop a new analyzer that will serve as a platform for several cancer tests in the future.
For the Evry, France-based company, which has to date focused its energies on developing and launching a flow cytometry test for a rare syndrome, the grant will support its vision of making its technology available as a platform for running oncology assays.
"This is the next growth driver for the company," said CEO Vincent Petit. "It's not a close-to-market solution and it's still in development by our company, but it's at a stage where we are beginning to work on clinical samples."
Petit cofounded the privately held firm eight years ago to commercialize a platform for detecting abnormalities in cellular energetics that had been developed at the French National Center for Scientific Research (CNRS). Metafora's technology involves targeting cellular nutrient transporters using receptor binding domain probes, or RBDs, a class of reagents that attaches to the transporters, enabling scientists to measure, using automated flow cytometry instruments and analysis tools, their quantity and characterize how they are functioning.
The company's debut assay on the platform was MetaGlut1, a flow cytometry-based assay for diagnosing glucose transporter 1 (Glut1) deficiency syndrome. Also known as De Vivo disease, the syndrome is rare and occurs when patients have a deficiency of the glucose transporter 1 protein, which is required for glucose to cross the blood-brain barrier. This lack of sugar in the brain can lead to epileptic seizures, ataxia, and developmental delay. Metafora achieved a CE-IVD mark for the test in 2017 and is now performing a validation study of MetaGlut1.
Its next goal is to develop a new automated platform called the CellMeta-Analyzer that would be capable of detecting diverse types of cancer cells, with tests detecting pancreatic and liver cancers, as well as colon cancer, at an early stage in the pipeline.
Petit said the CellMeta-Analyzer will have at its core a flow cytometry instrument. The company is currently focusing its efforts on developing reagents for the platform, "metabolic markers that allow us to characterize cell metabolism and form an energy profile for each cell using flow cytometry." The company is also developing software to analyze the data and characterize the energy profiles of cells by cross-referencing the results with an internal database.
"We are currently looking at different cell types, particularly in cancer," noted Petit. "The whole system should be able to provide physicians with actionable results by deciphering cell metabolism and providing diagnostic answers, prognoses, and therapeutic monitoring as well."
While he stressed that the CellMeta-Analyzer is "more early stage" compared to the MetaGlut1 test, he did provide some further detail around the company's plans. He noted that the firm's assays will be able to adapt to most flow cytometers used for in vitro diagnostics. "The innovation is on what is going in and what is coming out" of the instrument, he noted. "At the end, it will look like a common flow cytometer with unique markers and software and a database to provide detailed analysis of each sample."
In addition to the recent award, the company may seek additional funding to support the development of the system. Petit commented that there is "quite a lot of R&D to perform," not to mention a need to carry out pilot studies and validation studies, before it can be CE-IVD marked for the European clinical market.
The company's immediate goal is to assemble a prototype that can be used in an initial pilot study. But should the CellMeta-Analyzer progress to clinical use, perhaps in the next two to three years, Petit believes the platform could be used for a variety of indications.
"Our tests could be able to address different questions during the lifetime of the patient," said Petit. "It could be used for early diagnosis, prognosis, and therapy monitoring," he said. Metafora is also considering developing a multicancer panel, as well as developing more precisely targeted assays depending on market need.
"We believe we will have big avenues ahead of us," said Petit. "We will work out to position the test on each cancer so it can provide something really different for routine daily practice."
Petit declined to comment on a US or a European strategy for the test at this point in time. It is also uncertain which tests will reach the market first when the CellMeta-Analyzer launches.
For now, the commercial focus of Metafora is MetaGlut1.
Clinicians currently use a lumbar puncture followed by a sequencing test to identify a genetic mutation in the SLC2A1 gene, which encodes the glucose transporter protein, to diagnose De Vivo patients. Metafora has marketed its blood-based test as an alternative to lumbar puncture that can be administered to newborns, enabling patients to get treatment earlier.
Last June, Metafora received a €3.2 million grant to support a large-scale prospective validation study of METAglut1. The company received the funds as part of the second phase of the European Commission's Horizon 2020 SME Instrument program. The aim of the effort is to show that the test can detect Glut1 deficiency more efficiently than lumbar puncture sequencing. Metafora hopes the study will result in widespread adoption of the test within France, as well as reimbursement within the French healthcare system.
In October, the company commenced the study, seeking to partner with around 40 neurology centers in France, including the Pitié Salpêtrière and Robert Debré hospitals, and Laboratoire Cerba, the latter of which has offered MetaGlut1 as a service in France, Belgium, and Luxembourg. Metafora has said it aims to test between 2,000 and 3,000 people as part of the study.
Petit said this week that since commencing the study, Metafora has managed to make the test available through 25 centers and should reach its goal of having close to 40 centers involved in the study by June. The company expects the validation study to continue through 2020 and expects to publish the results of the study in early 2021, he said.