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Courtagen's Mitochondrial DNA Sequencing Projects Could Lead to New Protein Array Tests

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Variants discovered through sequencing of mitochondrial DNA could find their way onto Courtagen Life Sciences' protein array panels, according to the firm's chief scientific officer.

In particular, the company sees potential for such sequencing-informed, protein-based assays in mitochondrial disease testing, and has also considered the use of such panels in quality control testing for medical cannabis, Kevin McKernan told BioArray News this week.

"We don't see the diagnostic space as protein versus DNA but both informing the other," said McKernan. "In a time where variants of unknown significance dominate most exome tests, we see this synergy as an imperative."

At last week's Copenhagenomics conference in Copenhagen, Denmark, McKernan discussed in a presentation the possibility that Courtagen could migrate variants discovered using mitochondrial DNA sequencing to its Avantra Q400 Biomarker Workstation.

Following the conference, McKernan added that such protein array tests could be used to monitor the quality of medical cannabis. "The key safety concerns voiced to us by representatives are mold and pesticide exposure to immuno-compromised patients," McKernan said. He added that enzyme-linked immunosorbent assays are traditionally used to monitor the quality of cannabis.

Courtagen's research-use-only Avantra Q400 Biomarker Workstation consists of an assay-processing and fluorescence-imaging platform and disposable biochips that contain all the reagents required for performing multiplex biomarker assays. The Woburn, Mass.-based company last month announced that it had submitted its first pre-investigational device exemption information package to the US Food and Drug Administration for the Avantra and its QPDX BioChip multiplex protein immunoassay for the measurement of C-reactive protein, an inflammation marker (BAN 5/15/2012).

McKernan said that the Avantra system is "ideally suited" for cannabis quality-control testing, but stressed that the privately held firm's "resources and core focus are currently on markets less obfuscated by the law," such as mitochondrial disease.

Nineteen states in the US have legalized medical cannabis or have effectively decriminalized it. In California alone, the medical cannabis industry is estimated to be worth about $1.7 billion. Still, marijuana has been an outlawed drug at the federal level of government since the 1970 passage of the Controlled Substance Act.

"The medical cannabis market is a growing market and one we are watching carefully but will not be engaged in until the political landscape becomes [clearer], said McKernan.

McKernan joined Courtagen as CSO earlier this year after serving as CEO of Marblehead, Mass.-based Medicinal Genomics, which he also founded. Courtagen acquired Medicinal Genomics late last year for an undisclosed sum. The firm focused on the genomics of cannabis and hemp to "build a stronger scientific environment for the study of cannabis-based therapeutics and hemp-based fiber, food, and fuels," according to Courtagen's website. Last year, the company said that it had sequenced the genomes of two cannabis strains using the Roche 454 platform.

Kevin McKernan's brothers, Brian McKernan and Brendan McKernan, serve as CEO and president of Courtagen Life Sciences, respectively.

Prior to founding Medicinal Genomics, Kevin McKernan was vice president of R&D of Life Technologies where he managed the development of Life Technologies' next-generation SOLiD sequencing technology. He also helped develop the SOLiD technology at Agencourt Personal Genomics, a company he founded with his brothers. APG was acquired by Life Tech's predecessor Applied Biosystems in 2006.

"We were both building businesses that needed sequencing," and decided that sharing a sequencing facility made more sense than building two separate resources, McKernan said at the time (CSN 1/18/2012).

Through its acquisition of Medicinal Genomics, Courtagen gained that company's next-generation sequencing resources, which it used to launch mtSEEKPDx, a next-gen sequencing based test for mitochondrial diseases in adults and children. The company runs the test in its CLIA-certified lab, and sequences the entire mitochondrial genome using Illumina technology.

Indeed, Elizabeth Holland, vice president of human resources and business operations, told BioArray News this week that the "current core focus" of Courtagen Life Sciences is mitochondrial disease. "We believe that sequencing and protein-based assays for mitochondrial disease will provide answers to clinicians and patients so all of our energy and resources are currently focused in this area," she said.

Still, Holland confirmed that the company is interested in moving variants discovered using its next-gen sequencing platforms to the Avantra.

"Growth factors in the blood have been shown to inform mitochondrial DNA mutations of unknown function," Holland said. "We believe many variants of unknown function can be better understood through protein-based tests in the blood," she said, without elaborating. "Down the road we will explore how our technology would apply to a variety of different applications, and cannabis could be one of them, but that is not our core focus right now."

According to Holland, Courtagen currently is equipped with one Illumina HiSeq and two MiSeqs. According to its website, it also uses the ABI 3730xl capillary sequencing platform and Roche's NimbleGen SeqCap EZ capture method.

Courtagen Life Sciences was founded as Avantra Biosciences in 2010 when Charlestown, Mass.-based Courtagen Capital acquired the assets of Decision Biomarkers, a protein biomarker technology firm that filed for Chapter 7 bankruptcy in 2009 and soon after shuttered its doors.

After that acquisition, Avantra changed its name to Courtagen Life Sciences and relaunched DBI's Avantra Q400 Biomarker Workstation. Since then the firm has added a number of focused panels for use on the station, including a chip for studying angiogenesis. Last year, Courtagen also launched a custom assay-development service through which customers request specific biomarker panels that Courtagen fabricates and optimizes (BAN 8/24/2010).

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