B cells on the A-list

HTG Molecular Diagnostics and Sanofi US collaborate to identify B-cell malignancy biomarkers

Jeffrey Bouley
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TUCSON, Ariz.—In an effort to develop tests that helpidentify patients most likely to respond to targeted therapy—a key step towardmaking personalized medicine practical—HTG Molecular Diagnostics hasestablished a collaborative program with Bridgewater, N.J.-based Sanofi US, asubsidiary of French company Sanofi. In this program, the companies will worktogether to identify B-cell malignancy biomarkers that may lead to the developmentof a molecular companion diagnostic test to help identify patients most likelyto respond to a novel Sanofi investigational agent that the companies declineto name at this time.
 
Sanofi tapped HTG Molecular Diagnostics in part because ofthe latter company's qNPA technology, which measures mRNA and/or miRNAexpression in formalin-fixed paraffin-embedded (FFPE) tumor samples, allowingclinicians to verify the presence of certain biomarkers relevant to patientselection and therapy.
 
In the news release about the deal, TJ Johnson, CEO of HTGMolecular Diagnostics, noted that he is "pleased to be a partner with Sanofi inanswering the need for personalized cancer treatments," since his company'sqNPA "offers options in diagnostics testing of FFPE tissues not available inother commercial technologies."
 
 
But it isn't the first time the companies have workedtogether.
 
 
"To put it in context, we've had business relations withvarious areas in sanofi-aventis [as Sanofi was named prior to May 2011] forprobably four or five years, and as HTG's business has focused much heavierinto clinical applications around companion diagnostics and eventuallymolecular diagnostic tests, we've been making inroads and having discussionswith many of the clinically oriented and biomarker areas within large pharmas,including the folks at Sanofi," Johnson tells ddn.
 
 
He says there was no specific tipping point at which aconscious decision was made to do work along the lines of this biomarkercollaboration, nor is there a narrow strategic goal with this specificcollaboration.
 
 
"It's really been a natural progression of ourrelationship," Johnson says. "As the strategy of HTG has shifted significantlyaway from being a tools company to really focusing on diagnostics, it was a naturalfunction of the evolution of both our company and the relationship withSanofi."
 
 
That evolution of his own company included a refinancing ofHTG last year and a move to bring in new strategic investors, Johnson explains,as well as bringing in a new team of "seasoned diagnostic veterans based aroundreally great technology for FFPE. The confidence of our leadership team overthis path is really building our relationships with clinical and biomarkergroups across a wide swath of pharmaceutical companies. Our longstandingrelationship with Sanofi eased our pathway into their biomarker areas, but it'salso a testament to our shift in focus and our commitment, which has led todoors opening with multiple pharmaceutical clients."

Jeffrey Bouley

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