Sanofi tapped HTG Molecular Diagnostics in part because of the latter company’s qNPA technology, which measures mRNA and/or miRNA expression in formalin-fixed paraffin-embedded (FFPE) tumor samples, allowing clinicians to verify the presence of certain biomarkers relevant to patient selection and therapy. In the news release about the deal, TJ Johnson, CEO of HTG Molecular Diagnostics, noted that he is “pleased to be a partner with Sanofi in answering the need for personalized cancer treatments,” since his company’s qNPA “offers options in diagnostics testing of FFPE tissues not available in other commercial technologies.”

But it isn’t the first time the companies have worked together.

“To put it in context, we’ve had business relations with various areas of sanofi-aventis [as Sanofi was named prior to May 2011] for probably four or five years, and as HTG’s business has focused much heavier into clinical applications around companion diagnostics and eventually molecular diagnostic tests, we’ve been making inroads and having discussions with many of the clinically oriented biomarker areas within large pharmas, including the folks at Sanofi,” Johnson tells ddn.

He says there was no specific tipping point at which a conscious decision was made to do work along the lines of this biomarker collaboration, nor is there a narrow strategic goal with this specific collaboration.

“It’s really been a natural progression of our relationship,” Johnson says. “As the strategy of HTG has shifted significantly away from being a tools company to really focusing on diagnostics, it was a natural function of the evolution of both our company and our relationship with Sanofi.”

That evolution of his own company included a refinancing of HTG 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 around really great technology for FFPE. The confidence of our leadership team over this path is really building our relationships with clinical and biomarker groups across a wide swath of pharmaceutical companies. Our longstanding relationship with Sanofi eased our pathway into their biomarker areas, but it’s also a testament to our shift in focus and our commitment, which has led to doors opening with multiple pharmaceutical clients.”

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TJ Johnson, CEO of HTG Molecular Diagnostics states, “Chris is a valuable addition to the HTG Molecular Diagnostics team. He will develop a key opinion leader network and build a diagnostic product concept portfolio that will be instrumental in driving validated concepts into IVD development or out-licensing.”

Mr. Rua’s presentation will offer an industry perspective on the recently released FDA guidance for commercialization of RUOs and IUOs as well as on potential new guidance on LDTs. Attendees will receive a 360 degree view of the current and future state of the regulatory landscape for the commercialization of RUOs, IUOs, and LDTs.

Sam Rua, vice president of regulatory affairs and quality systems, joined HTG Molecular in 2011, and directs the quality systems organization and global regulatory initiatives. Prior to joining HTG, Mr. Rua served in a variety of quality and regulatory roles with Ventana Medical Systems, a member of the Roche Diagnostics Group. Mr. Rua has successfully led applications for PMA approvals and clearances for multiple IVD and companion diagnostic tests. His career includes positions as VP of global regulatory and clinical affairs at Beckman Coulter, and executive director of quality and regulatory at Third Wave Technologies, Inc. (now Hologic), where he led the regulatory and clinical strategies for the Invader® UGT1A1 test and the Invader® HPV test. Mr. Rua received his B.S. in Microbiology from the University of Arizona.

According to HTG and Sanofi, the aim of their joint effort is “to identify biomarkers that may lead to the development of a molecular companion diagnostic test to help identify patients most likely to respond to a novel Sanofi investigational agent.”

The partners did not reveal the specific Sanofi drug to be used in the collaboration. However, using the qNPA platform, HTG will try to identify drug response markers in B-cells, which are a type of white blood cells that that make antibodies critical for immune system function and which play a role in a number of diseases, including acute lymphocytic leukemia.

Sanofi is investigating SAR3419, an inhibitor of the CD19 antigen, for the treatment of CD19-positive non-Hodgkin’s lymphoma and other B-cell malignancies.

At the American Society of Clinical Oncology’s annual meeting last year, data from a Phase I/II Sanofi-led study in patients with relapsed or refractory B-cell NHL expressing the CD19 antigen showed that SAR3419 was clinically active and the toxicities associated with the treatment were manageable.

Sanofi is also conducting Phase II investigations with SAR3419 in diffuse large B-cell lymphoma, the most common type of NHL; and B-cell acute lymphoglastic leukemia. ImmunoGen developed SAR3419 and licensed it to Sanofi as part of a collaboration between the firms.

HTG’s qNPA technology measures mRNA and miRNA expression in formalin-fixed paraffin-embedded tumor samples, which the company claims allows certain advantages over other platforms.

In a 2008 publication in Blood, researchers from HTG, the University of Arizona, and elsewhere discussed data from a study in which they used HTG’s qNPA assay to analyze FFPE tissue blocks from 36 genes previously associated with diffuse large B-cell lymphoma. “Gene-expression profiling studies in cancer have relied on snap-frozen tissues, which are often not obtained at diagnosis and are becoming decreasingly available in the current era of small biopsies,” Rimsza et al. wrote in the article. In this study, the researchers used the qNPA assay to try to “overcome this obstacle.”

The investigators analyzed more than 200 cases by qNPA, and reported that low levels of HLADRB and high levels of MYC are “independent indicators of survival, together distinguishing cases with the worst [diffuse large B-cell lymphoma] prognosis.”

Overall, Rimsza et al. concluded that “prognostic genes can be meaningfully quantified using qNPA technology on FFPE tissues; previous [gene expression profiling] findings in [diffuse large B-cell lymphoma] are relevant with current treatments; and two genes, representing immune escape and proliferation, are the common features of the most aggressive [disease].”

HTG CEO TJ Johnson told PGx Reporter that qNPA technology doesn’t require RNA extraction, labeling, or amplification. Furthermore, the test can accurately analyze small sample volumes, even when the samples are degraded, and can gauge very small expression level changes. According to HTG’s website, the company has found that the qNPA technology “correlates well” with immunohistochemistry staining.

In addition to biomarker discovery solutions, the company also provides verification and validation services, which have been attractive for Sanofi and other pharmas, Johnson noted. “We can also effectively move the biomarker set from prototype to investigational-use only to IVD assay quality in rapid fashion — much quicker than other technologies,” he added.

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Development of tests that help identify patients most likely to respond to targeted therapy is a key step toward the personalization of medicine

TUCSON, Ariz. (March 30, 2012) – HTG Molecular Diagnostics has established a collaborative program with Sanofi US to identify biomarkers that may lead to the development of a molecular companion diagnostic test to help identify patients most likely to respond to a novel Sanofi investigational agent. HTG Molecular Diagnostics’ qNPA technology measures mRNA and/or miRNA expression in formalin fixed paraffin embedded (FFPE) tumor samples, allowing clinicians to verify the presence of certain biomarkers relevant to patient selection and therapy.

“We are pleased to be a partner with Sanofi in answering the need for personalized cancer treatments. qNPA offers options in diagnostics testing of FFPE tissues not available in other commercial technologies,” said TJ Johnson, CEO of HTG Molecular Diagnostics.

Mr. Johnson joined HTG Molecular in January 2008 from LVC Consulting, where he was a partner. Prior to LVC, Mr. Johnson served as a senior vice president with Ventana Medical Systems, where he oversaw manufacturing operations, quality, strategic marketing, corporate development, and product technical support during his five years with the company. He had previously served as vice president of global marketing at Hill-Rom Company, a subsidiary of Hillenbrand Industries, and as vice president/general manager of Hill-Rom Airshields where he directed North American operations, and lead the global strategic planning team. Mr. Johnson also serves on the board of directors for Kalypto Medical. He earned a BS in business from Indiana University.

Dr. Seligmann founded High Throughput Genomics (now HTG Molecular) in 1997. An internationally recognized scientist, Dr. Seligmann began his scientific career at the NIH-NIAID, Laboratory of Clinical Investigation, and then joined Ciba-Geigy (Novartis). There he led the drug discovery programs within the department of molecular biology, inflammation, and osteoarthritis research. As one of the inventors and developers of the intellectual property forming the basis of the array plate and qNPA technology, Dr. Seligmann’s vision is to provide this time and cost saving technology to assist the advancement of research, drug discovery and the development of better therapies and diagnostics, which ultimately provide better patient care and quality of life.