HTG Molecular Diagnostics and Merck KGaA, Darmstadt, Germany, Enter Into a Master Companion Diagnostics Agreement
October 11 2016 - 3:01PM
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (“HTG”), a
provider of instruments and reagents for molecular profiling
applications, and Merck KGaA, Darmstadt, Germany, have entered a
broad companion diagnostics master agreement. The initial
development program agreement utilizes the HTG EdgeSeq DLBCL Cell
of Origin Assay in the Merck KGaA, Darmstadt, Germany, M7583,
selective and irreversible inhibitor of Burton’s Tyrosine Kinase
(BTK), program.
“We are honored to be chosen as the diagnostic
development partner for Merck KGaA’s BTK program and our team is
now focused on the near-term milestones. Additionally, having
a master companion diagnostic agreement paves the way for
additional development collaborations,” stated TJ Johnson, HTG’s
President and CEO. “We have worked very hard to establish the
organizational capabilities to support the development, regulatory
filing and commercialization of companion diagnostics demonstrated
by the recent CE/IVD marking of HTG’s DLBCL cell of origin assay,”
added Mr. Johnson.
About HTG:
Headquartered in Tucson, Arizona, HTG’s mission is
to empower precision medicine at the local level. In 2013, the
company commercialized its HTG Edge instrument platform and a
portfolio of RNA assays that leverage HTG’s proprietary nuclease
protection chemistry. HTG’s product offerings have since expanded
to include its HTG EdgeSeq product line, which automates sample and
targeted library preparation for next-generation sequencing.
Additional information is available at www.htgmolecular.com.
Safe Harbor Statement:
Statements contained in this press release regarding matters that
are not historical facts are “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements associated with the anticipated benefits
of our agreement with Merck KGaA, and our ability to support the
development, regulatory filing and commercialization of companion
diagnostics. Words such as “believes,” “anticipates,” “plans,”
“expects,” “intends,” “will,” “goal,” “potential,” and similar
expressions are intended to identify forward-looking statements,
though not all forward-looking statements necessarily contain these
identifying words. These forward-looking statements are based upon
management’s current expectations, are subject to known and unknown
risks, and involve assumptions that may never materialize or may
prove to be incorrect. Actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a result of various risks and
uncertainties, including, without limitation, the risk that we may
not realize the expected benefits from our agreement with Merck
KGaA, risks associated with the utility of our automation systems,
proprietary profiling panels and solutions, and our ability to
successfully manufacture and supply our products. These and other
factors are described in greater detail in our filings with the
Securities and Exchange Commission, including, without limitation,
our Quarterly Report on Form 10-Q for the quarter ended June 30,
2016. All forward-looking statements contained in this press
release speak only as of the date on which they were made, and we
undertake no obligation to update such statements to reflect events
that occur or circumstances that exist after the date on which they
were made.
Contact: Westwicke Partners
Jamar Ismail
Phone: 415-513-1282
Email: jamar.ismail@westwicke.com
TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: 520-547-2827 x130
Email: tjjohnson@htgmolecular.com
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