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MultiplexDX on Track to Launch New FISH, NGS-Based Breast Cancer Test by 2023

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NEW YORK – MultiplexDX plans to introduce by 2023 a new test for diagnosing breast cancer and guiding treatment decisions. The company's approach involves using both fluorescence in situ hybridization (FISH) and next-generation sequencing to provide clinicians with treatment recommendations for each patient, as well as to help them avoid cancer misdiagnosis.

"If both results agree, then you know you have the right quantification and the accuracy is high," said CEO Pavel Čekan. "So when we say it is HER2 positive, then we are very certain that it is HER2 positive."

Čekan has led MultiplexDX since 2016 when he co-founded the company after returning to Slovakia from the US National Cancer Institute in Bethesda, Maryland, where he was a research fellow. The company is based at the Comenius University Science Park in Bratislava and employs 15 people, half of whom are focused on MultiplexDX's commercial business, the other half on R&D, including the development of its new test for breast cancer called Multiplex8+.

Over the past two years, the firm has been accumulating funds from sources, most recently a €3 million ($3.3 million ) European Innovation Council grant through the EIC's Accelerator program. Awarded in December, the grant will support a restrospective clinical validation of the test in 4,000 archival tissue samples from Slovakia, Austria, the Czech Republic, and Iceland.

In addition to validating the test, the EIC award will also help MultiplexDX map out a commercialization strategy. Čekan said that over the next few years, the company intends to build an ISO-certified facility in Bratislava that can offer Multiplex8+ as a service. Initial clients will be private cancer centers in Europe.

"Here we are not limited to Slovakia or Central Europe," said Čekan. "We want to offer this to the biggest private cancer markets in Germany, Austria, Switzerland, France, and the UK."

The company sees Agendia's MammaPrint diagnostic and Genomic Health's Oncotype DX test as models for introducing its own breast cancer testing service in the future. After a debut on the European private cancer testing market in 2023, MultiplexDX itneds to work on winning reimbursement for the test in Slovakia and perhaps surrounding countries by 2026, Čekan said. Once the test is covered in Europe, the company is eyeing a potential market launch in the US and Asia.

If it does expand operations to the US, it would continue to serve the market via a service model and would set up a clinical laboratory in the US, with a potential site at the Inova Schar Cancer Institute in Fairfax, Virginia, Čekan suggested.

While the company has much of the decade mapped out, it sees breast cancer as just one indication for its approach of combining RNA FISH with RNA-seq. "We chose breast cancer for multiple reasons," noted Čekan. "It's probably the best studied cancer of all, and it's also one of the most frequent in women," he said, adding "breast cancer is also well archived."

Other indications of interest include prostate, skin, and lung cancer. Čekan said the company wants to expand into these disease areas "as soon as possible."

Combo test

The concept of Multiplex8+, noted Čekan, is the combination of two technologies -- visualization using RNA fluorescence in situ hybridization and next-generation sequencing. The company works with tissue samples and uses FISH to look at about 8 breast cancer markers. Once these signals are quantified, it uses laser microdissection to remove a specific piece of the tumor from which RNA is extracted and sequenced. The concordance of the markers' expression using FISH and sequencing is then assessed.

"The whole point of Multiplex8+ is using two technologies, digital visualization and sequencing," said Čekan. "Our R&D team is trying to combine those two technologies and then validate this diagnostic test and then commercialize it."

The company believes by combining the two it will overcome inherent limitations in either. Conventional visualization assays don't supply clinicians with precise data, while RNA molecular diagnostic assays miss tissue morphology and localization data, according to Čekan.

FISH and sequencing also form the backbone of the company's commercial services offering. These include DNA and RNA FISH core services, including probe design, synthesis, and validation; multi-labeled FISH probes to support enhanced signal amplification; and a kitted offering called FullRNALook. On the sequencing side, MultiplexDX offers small RNA library preparation kits and barcoded pre-adenylated 3'-adapters. Its sequencing products are compatible with Illumina instruments.

The company also offers custom oligonucleotides and is mulling expansion in the business. "One idea is to take the whole commercial package and build an oligo house," said Čekan. "We would be providing and selling highly specialized oligos with all kinds of services around them," he said. MultiplexDX may soon seek new funding to support investments in this business area.

The company is also developing a companion diagnostics business by partnering with biopharmaceutical companies to develop tests based on quantifying companion biomarkers to provide additional data for the effective use of their drugs. Last year, the company became a member of the Oslo Cancer Cluster, an oncology research and industry cluster headquartered in the Norwegian capital, joining a roster of 90 other companies and organizations, among them Pfizer, Abbvie, Merck, and AstraZeneca.

"We would like to cooperate with pharma companies on companion diagnostic projects and biomarker discovery projects," said Čekan. He said that MultipleDX will open a new facility in Oslo in 2021 as part of its membership in the cluster.