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Belgium's Multiplicom Raises $2.9M to Pursue CE Mark for Breast Cancer, CF Tests

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By Ben Butkus

University of Antwerp spinout Multiplicom last week received its first significant investment, a €2 million ($2.9 million) financing that will enable the company to pursue a CE Mark for in vitro diagnostic use of its multiplexed PCR assays for clinical breast cancer and cystic fibrosis sequencing.

Belgian VC Gimv and Gimv-managed fund Biotechfonds Vlaanderen together led the investment with €1.5 million; while life sciences research institute VIB and the University of Antwerp together chipped in €500,000.

In addition to pursuing diagnostic applications, Multiplicom will use the cash infusion to expand its European sales and marketing force, as well as its product portfolio, which already includes multiplexed PCR assay kits for next-generation sequencing target enrichment and copy number variation analysis, Multiplicom founder and CSO Jurgen Del-Favero said this week.

Originally founded as Multiplicon (with an "n") in early 2010 out of Del-Favero's laboratory in the VIB Department of Molecular Genetics at the University of Antwerp, the company last month tweaked its named and hired its first outside executive, CEO Dirk Pollett, founder of molecular diagnostics firm Innogenetics, and former executive at outfits such as Cellectis and Galapagos.

"Before this we were only like a group of scientists, but now we have on board an experienced CEO … who has a very good view on the field of diagnostics, so that's very important to have," Del-Favero told PCR Insider.

Multiplicom's core technology, developed at the University of Antwerp, is a proprietary software tool called Multiplexer for the in silico design of multiplex PCR assays.

"While there are a number of these software tools available, the nice thing about our software is if we take the in silico results and bring them into the lab, they actually work as a standard PCR," Del-Favero said. "We don't use special equipment or tricks. It's just a standard PCR reaction, but multiplexed."

The company was able to quickly parlay Multiplexer's capabilities into a small portfolio of assay products that it currently sells to customers in Europe, South America, and Australia.

The company's first assays, named "multiplex amplicon quantification," or MAQ, assays, were designed for high-throughput copy number variation analysis, Del-Favero said.

Compared to competing assays, such as multiplex ligation-dependent probe amplification assays from Holland's MRC, which require multiple PCR tube additions, MAQ assays are performed in one step in a single closed tube, according to Del-Favero.

"You put everything in, and when PCR is finished you put it on a fragment analyzer, and then everything is finished," he said. "For diagnostics, this is of course much safer and better."

Multiplicom's second assays are "multiplex amplification of specific targets for resequencing," or MASTR, kits, intended for use on the front end of next-gen sequencing platforms. Del-Favero said that these assays are designed to provide better sequencing efficiency and lower cost than array- or liquid-based sequence-enrichment methods.

And finally, Multiplicom's third product category includes "all the multiplexed assays that are not a MAQ or MASTR assay," for example, assays for detecting verotoxin-producing E. coli; and a test for determining whether maternal DNA contamination is present in genetic samples obtained from newborns for aneuploidy testing.

So far, the company has been able to use Multiplexer to design working PCR assays with 75 amplicons, or 150 primers, in a single reaction "without overlap and without giving spurious PCR products and artifacts," Del-Favero said, adding that "we can probably go higher."

It is this multiplexing capability that the company seeks to exploit in shifting its existing MASTR assays for BRCA 1 and BRCA 2 analysis, as well as for cystic fibrosis testing, into CE IVD Marked products for use in clinical sequencing applications. Currently these assays are for research use only.

Multiplicom said that its tests will allow for an early determination of whether an individual has an increased risk of developing disease; for the early detection of congenital genetic defects; or to identify the most appropriate therapy for patients.

"We're working on that, and hope to have the first broad CE Marked product by the end of Q3 or in Q4," Del-Favero said. "This is our first goal, together with expanding our portfolio."

The company is eyeing the US market, but "at the moment there are some issues, for instance, with Myriad's patents around BRCA," Del-Favero said. "But that's certainly an area we want to expand to."

Beyond breast cancer and CF, Multiplicom is also working on assays for targeted clinical sequencing of colorectal cancer and cardiomyopathy, he added.

Del-Favero said that the company has been contacted by "major players" in the next-gen sequencing arena, although he declined to disclose their identities, citing the early nature of discussions.

Multiplicom said that it is also collaborating with undisclosed pharma companies to use its technology to identify genetic markers linked to drug safety and efficacy.


Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.

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