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Multiplicom to Expand Test Sales in Europe; Launch Hereditary Cancer Panel in US Through Partner

NEW YORK (GenomeWeb) – Molecular diagnostics firm Multiplicom of Belgium seeks to expand sales for its cancer predisposition, tumor analysis, and noninvasive prenatal tests in Europe as it prepares to launch a hereditary breast and ovarian cancer panel in the US through a partner laboratory.

The privately owned company, which was founded in 2011 as a spinoff from the University of Antwerp and non-profit life sciences research institute VIB of Ghent, is also working on new tests and applications, including a liquid biopsy test for cancer.

Multiplicom, which currently has about 70 employees, offers target amplification assays for diagnostic use and clinical research that are based on its proprietary multiplex PCR technology, called Multiplex Amplification of Specific Targets for Resequencing (MASTR). Laboratories use the assays to amplify genes for analysis by next-generation sequencing.

In 2012, the company received the CE-IVD mark for its first diagnostic assay, BRCA MASTR Dx, which amplifies the coding regions of BRCA1 and BRCA2 and is designed to detect germline mutations in individuals with an increased risk for breast and ovarian cancer.

According to Multiplicom's website, more than 60 percent of European diagnostic labs use BRCA MASTR Dx. Word of mouth has been "extremely important as a marketing tool" in penetrating the highly fragmented European BRCA testing market, Pollet said. 

BRCA MASTR Dx is available for use with several next-gen sequencing platforms, he said, though labs tend to run it on the Illumina MiSeq or NextSeq systems. When the assay was first launched, most users were running it on the 454 platform, which Roche has since discontinued. But because the assay is compatible with several NGS platforms, customers were able to switch to the MiSeq without any problems. "They had no problem whatsoever doing this conversion because we could help them make sure they had exactly the same results," Pollet said.

The BRCA assay is not the firm's only diagnostic test. This week, Multiplicom said it received the CE-IVD mark for its BRCA Tumor MASTR Plus Dx assay, a companion diagnostic test to identify BRCA1 and BRCA2 mutations in formalin-fixed paraffin-embedded tissue from ovarian cancer patients who might be eligible for treatment with PARP inhibitors. Pollet said the company developed the test with AstraZeneca.

In January, the company had already released BRCA Tumor MASTR Plus Dx as a CE-IVD-labeled test to assess BRCA1 and BRCA2 mutations in FFPE tumor samples using an Illumina MiSeq system. In addition, Multiplicom offers a CE-IVD-labeled diagnostic assay for cystic fibrosis, called CFTR MASTER Dx, and Clarigo, a noninvasive prenatal test for chromosomal aneuploidies for which it received CE-IVD marking last fall.

With Clarigo, the company has been targeting smaller laboratories in Europe that want to offer NIPT locally but initially have only a few samples per week to run, Pollet said, noting that "quite a few players" are already serving the larger diagnostic laboratories. Illumina and Roche's Ariosa Diagnostics, for example, have transferred their NIPT technology to a number of labs in Europe over the past few years.

"The niche we are looking at is the smaller local labs who want to start using molecular diagnostics and want to start with NIPT," Pollet said. Labs in several countries have already started offering Clarigo routinely, he added, and Multiplicom is working with "quite a few labs" to validate the test.

More CE-IVD products will follow later this year, Pollet said, based on tests the company currently offers for research use only. Among the firm's RUO tests are a breast cancer predisposition panel called BRCA Hereditary Cancer MASTR Plus that covers mutations and copy number variants in 26 genes, as well as assays for hereditary colon cancer, various genetic disorders, and tumor tissue analysis.

In addition to converting more RUO assays into CE-IVD products, adding new genes to existing tests, and developing assays for FFPE tissue, Multiplicom is working on a liquid biopsy test for cancer. "The experience we have with free-floating DNA from our Clarigo test in the NIPT field helps us a lot in developing [liquid biopsy] applications in the cancer field," Pollet said. The goal is to bring a first circulating tumor DNA test to market at the end of this year or early next year, most likely for disease detection, he said, though the precise application will depend on how internal research projects are moving along and what tests competitors are developing.

Since Multiplicom sells its tests to laboratories, it is only indirectly affected by reimbursement. Pollet said all of its diagnostic tests are reimbursed in the majority of European countries, but not necessarily all of them.

To promote its tests more widely, Multiplicom plans to increase its sales and marketing team this year and to grow its overall staff to about 90 employees. It also wants to open sales offices in the UK and in Germany. Earlier this year, the firm opened a sales office in France, taking over several employees of a distributor, InfYnity Biomarkers, that it had previously worked with. "It's time we put more effort on the marketing and sales side so that we can maximize the revenue from products sales," Pollet said.

In addition, the company is looking to expand into the US market. Within the next month, it plans to launch its 26-gene BRCA Hereditary Cancer MASTR Plus panel in the US, in collaboration with a currently undisclosed CLIA-certified laboratory.

On the financial side, the company may raise additional funding later this year but has not decided on this yet, Pollet said, though any fundraising will be on a similar scale as previous rounds. Three years ago, the company raised €5.5 million ($6 million) from existing and new investors. "We've been growing our revenue from product sales substantially, so our losses are quite minimal," he said, adding that the company has been profitable for some years and incurred a small loss in others.