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BioMerieux Invests $5M in Knome; Licenses Firm's Analysis Platform for Sequencing-Based IVDs

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By Julia Karow

This story, originally published April 21, has been updated to include additional information from BioMérieux and Knome officials.

Diagnostics company BioMérieux and genome analysis firm Knome will collaborate to develop in vitro diagnostics based on next-generation sequencing, the companies said last week.

The collaboration is part of a five-year strategy that BioMérieux unveiled in March to incorporate next-gen sequencing into an in vitro diagnostics platform.

As part of the deal, the French company made a $5 million equity investment in Knome, a privately held provider of genome sequencing and interpretation services, gaining a stake of less than 10 percent in the Cambridge, Mass.-based firm.

Under the agreement, BioMérieux has exclusive rights to license Knome's proprietary genome analysis platform for use in the in vitro diagnostics market. In return, Knome is gaining access to BioMérieux's intellectual property regarding DNA extraction and sample preparation.

According to BioMérieux CEO Stéphane Bancel, the company sees next-generation sequencing "as an exciting new technology for diagnostics" that it wants to make widely available in the clinic, "so patients around the world will have access to this type of groundbreaking technology."

"We want to bring an IVD, an FDA-approved product [to market] that can be used in any hospital in the country and in the world," Bancel told In Sequence last week.

He said the company wants to develop an entire platform — including sample preparation, a sequencing instrument, and analysis software — that can be deployed in IVD laboratories. The plan is to focus initially on molecular diagnostic tests in the areas of sepsis and oncology, he said, followed later by cardiac disease. "We think that we'll have something approved and commercially available within the next five years," he said.

BioMérieux already has considerable market share in IVDs for microbial analysis, Bancel said, and it plans to sequence its large library of bacterial strains as part of developing infectious disease diagnostics.

In terms of the new platform, the company already has expertise in sample preparation and sells an instrument for automated isolation of nucleic acids from clinical samples, called NucliSens EasyMag.

For the sequencer, BioMérieux plans to partner with a vendor to develop an instrument under an OEM agreement. "We are just starting to investigate all these technologies," Bancel said, adding that the company is in discussions with several potential partners. He said the firm is considering both existing "second-generation" and nascent "third-generation" sequencing platforms.

Acquiring a sequencing platform provider — a route taken previously by another diagnostic player, Roche, which bought 454 Life Sciences in 2007 — would be another possibility, he said. "We have not decided yet if we will do a partnership or an acquisition," he added.

BioMérieux decided to partner with Knome after it realized it lacked the expertise required to process and analyze high volumes of sequence data. Knome, Bancel said, offered a unique combination of skills in both information technology and genetics, which no other company they considered had.

Knome will continue to further automate its genome analysis platform — which can use data from any sequencing platform — for the interpretation of sequence data. Later, it will develop customized tools for diagnostic applications with BioMérieux, he said.

For Knome, the partnership is the firm's first venture into diagnostics. "This is a way for us as a company to partner with a leader in IVD," Knome CEO Jorge Conde told In Sequence, stressing that the project is still "in very early stages."

Knome will continue to provide human genome analysis and interpretation services to both individuals and researchers on its own, and plans to start using BioMérieux's sample prep expertise for extracting DNA from stored tissues soon for some of the research projects.

BioMérieux will be in charge of integrating the IVD platform eventually, conducting clinical trials, dealing with regulatory issues, generating sequence databases, and commercializing the product. The company did not disclose whether Knome or other future partners will have a stake in any IVDs commercialized.

Challenges to developing the platform include the high cost of sequencing. "There is clearly still a cost challenge, because today, the cost of a genome — including both the sequencing and the analysis of a sequence — is high," Bancel said.

Data interpretation will be another issue. "As always in biology, we have to be very humble," he said. "There are a lot of mechanisms of action that we still do not understand at the biology and at the cell level."

And, finally, the high complexity of the biology will require BioMérieux to work in partnership with the FDA and other regulatory agencies in order to win approval for the new products, he said.

Knome has been providing personal genome sequencing and analysis services since 2007. The company has agreements with China's BGI and SeqWright, who serve as its sequencing providers, and also offers interpretation services for customers of Illumina's personal genome sequencing service. In addition, the company started to offer its sequencing and analysis services to researchers last year.

BioMérieux said it plans to develop cancer and infectious disease diagnostics using Knome's sequence analysis technology and bioinformatics tools, under the leadership of its chief technology officer, Alain Pluquet. The company said that developing multiplex DNA sequencing for molecular diagnostics is part of its 2015 strategic roadmap.

BioMérieux, based in Marcy L'Etoile, France, with US headquarters in Cambridge, Mmass., provides reagents, instruments, and software for diagnosing infectious diseases, cancer screening, monitoring cardiovascular emergencies, and detecting microorganisms in agricultural, food, pharmaceutical, and cosmetic products.

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