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J&J's Janssen Pharmaceutica to Develop MDx Assays for Biocartis' Integrated NAT Platform


By Ben Butkus

Biocartis said this week that it has entered into a strategic agreement with Janssen Pharmaceutica to co-develop molecular diagnostic assays for use on Biocartis' integrated "sample-to-answer" nucleic acid testing platform.

Janssen Pharmaceutica, part of Johnson & Johnson's Janssen Pharmaceutical subsidiary, becomes the third assay content provider for Biocartis' testing platform as the company drives toward a full commercial launch in the second half of 2012. Biocartis also has similar assay-development deals in place with BioMérieux and Debiopharm.

Under the agreement announced this week, Janssen, with involvement from J&J's Ortho Clinical Diagnostics unit, will have worldwide exclusive rights to develop and commercialize molecular assays on Biocartis' platform in the area of neurological disease and certain viral infectious diseases.

Biocartis and Janssen may also co-develop and commercialize certain assays; and Biocartis also retains the right to commercialize certain viral infectious disease assays in undisclosed geographical areas, Erik Vossenaar, Biocartis' director of business development, told PCR Insider this week.

Vossenaar declined to identify specific disease indications within the neurological or viral infectious disease areas, citing confidentiality agreements. However, he said that Biocartis expects development efforts for both areas "to start very soon."

As part of the deal, Biocartis will receive undisclosed upfront and milestone payments from Janssen Pharmaceutica, as well as royalties on future sales. Additional financial details were not disclosed. In April, Johnson & Johnson took an undisclosed equity stake in Biocartis as part of a €30 million ($41.3 million at the time) Series B financing for Biocartis (PCR Insider, 4/8/2010).

At the heart of the collaboration is Biocartis' molecular diagnostics platform, which the company acquired from Royal Philips Electronics in February 2010 (PCR Insider, 2/11/10).

The platform, whose design was inspired by various consumer electronics innovations such as semiconductor technology, is still under development at Biocartis, and integrates all steps of a multiplex molecular assay, including sample prep, amplification, detection, and analysis, all in a sealed, single-use disposable cartridge.

Biocartis' instrument, which does not yet have a commercial name, has also been developed for use with a variety of sample types, including blood, urine, sputum, tumor biopsies, and feces; and can employ a number of nucleic acid amplification and detection technologies.

"The PCR part of the platform is basically capable of using any kind of PCR detection chemistry," Vossenaar said. "It is possible to use a different chemistry from assay to assay, as long as it is homogeneous fluorescence based, as most of the chemistries are, such as TaqMan probes or Scorpions probes. It will be the decision of our development partners as to which assay chemistry they will use for their particular assays."

Long on engineering expertise, but short on assay development chops, Biocartis immediately began seeking assay-development partners for its platform following its acquisition from Philips. In April, it landed its first in Swiss biopharmaceutical conglomerate Debiopharm, which participated alongside J&J in Biocartis' Series B financing and said it would work with Biocartis to create companion diagnostic assays for oncology and infectious disease therapies.

In November, Biocartis inked another molecular diagnostics co-development pact, this time with BioMérieux, to develop and commercialize microbiology assays on the Biocartis platform. Under that deal, BioMérieux also gained the right to access Biocartis' platform for certain oncology and theranostic assays.

Vossenaar said this week that Biocartis is now targeting the second half of 2012 for the full commercial launch of its molecular diagnostics platform, along with its first assay, which will likely be through the BioMérieux collaboration.

According to an investor presentation on BioMérieux's website, the companies are focusing their co-development efforts primarily on hospital-acquired infections such as methicillin-resistant S. aureus, C. difficile, and vancomycin-resistant Enterococci; sepsis-causing agents; and companion diagnostic tests for genes such as BRAF and KRAS.

On the other hand, the assays that are the subject of the Janssen agreement "will likely be launched most a little bit later than the very first assays, so around the end of 2012 or early 2013," Vossenaar said.

Biocartis' strategy to bring its system to market through a series of exclusive collaborations is designed to not only provide Biocartis with a broad menu of assays that it otherwise would not have access to; but also should benefit all involved partners, according to Vossenaar.

"The unique thing about the agreements with all the parties is that the instruments that they place in the market will remain accessible to all of the assays from all the Biocartis partners," he said. "For instance, if BioMérieux markets our instrument, that platform will also be able to be used to process a Biocartis or Janssen assay."

Both BioMérieux and Janssen will have options to distribute the Biocartis platform as part of their agreements. Each company will be responsible for shepherding their respective assays through the regulatory approval process in the geographies covered in their agreements, Vossenaar said.

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