Myriad Genetics Announces Foundational Patent Granted for Molecular Residual Disease (MRD) with Early Priority Date
22 March 2024 - 12:40PM
Myriad Genetics, Inc., (NASDAQ: MYGN), a leader in genetic testing
and precision medicine, today announced that the United States
Patent and Trademark Office has issued a patent that will
strengthen its ability to deliver a tumor-informed,
high-definition, molecular residual disease (MRD) assay to
market.
U.S. patent 11,932,910, entitled Combinatorial DNA Screening,
covers Myriad’s foundational and proprietary method of preparing
cell free DNA. This method describes a key aspect of tumor-informed
MRD assays that detect circulating tumor DNA (ctDNA) through
sequencing. Specifically, the patented method relates to the manner
in which a sample is sufficiently enriched with ctDNA that it can
be detected, if present, with high sensitivity and specificity.
“The 2016 filing date of this patent—at the advent of MRD
development—highlights Myriad’s foresight about the potential role
of tumor-derived cell-free DNA in the expanding field of cancer
diagnostics,” said Paul J. Diaz, President and CEO, Myriad
Genetics. “The issuance of this patent showcases some of Myriad’s
novel proprietary technology that we believe will help advance
Myriad’s position as a precision medicine leader—both via its own
Precise MRD offering and via potential licensing opportunities in
the MRD space. We have developed our Precise® MRD assay by
leveraging Myriad’s existing technology, laboratory systems and
processes, infrastructure and intellectual property, building upon
our FDA-approved MyChoice® companion diagnostic and FirstGene
platforms. We believe that our unique set of capabilities will
enable us to profitably commercialize Precise MRD, advancing
oncology care for patients in this emerging under-penetrated
market.”
Myriad has made significant strides in developing its Precise
MRD assay. The test is currently being installed in the company’s
new state-of-the-art laboratory facility in Salt Lake City, where
it will soon undergo further validation to enable its use in a
range of applications, including biopharma studies and
interventional prospective trials. Myriad has announced several
important research collaborations: a retrospective study of MRD
efficacy in metastatic breast cancer with researchers at Memorial
Sloan Kettering, a retrospective analysis of MRD utility in
metastatic renal cell carcinoma with clinicians at The University
of Texas MD Anderson Cancer Center, and a prospective pan-cancer
study beginning in May with pioneering MRD researchers at the
National Cancer Center East in Japan.
“We will be presenting initial learnings from our retrospective
MRD studies in conferences this spring and summer, and we expect to
have full results from the renal study later this year,” said Dale
Muzzey, PhD, Chief Scientific Officer, Myriad Genetics. “We are on
track to process samples for biopharma partners by Q4’24 and to
submit to MolDx by year end, with commercial launch targeted for
the second half of 2025. The approach described in the granted
patent is core to our Precise MRD test, though in the years since
that initial filing we have continued to refine the test,
incorporating and protecting these innovations along the way.”
Precise MRD is available for use in research studies pursued
jointly by Myriad and academic or pharmaceutical investigators.
“The sensitivity and detection limit achieved with Precise MRD
allows it to perform across a wide range of indications, including
those with scarce ctDNA that were not well suited to
first-generation tests,” said Muzzey. “We intend for it to monitor
ctDNA levels throughout a cancer patient’s clinical care, starting
immediately after diagnosis and continuing through survivorship
monitoring. We see significant opportunity to pair Precise MRD with
MyRisk, our market-leading hereditary cancer test, and our recently
acquired Precise Tumor and soon to launch Precise Liquid tests, to
offer a comprehensive set of easy to use clinical decision support
tools for oncologists to advance the care of patients.”
About Myriad Genetics Myriad Genetics is a
leading genetic testing and precision medicine company dedicated to
advancing health and well-being for all. Myriad develops and offers
genetic tests that help assess the risk of developing disease or
disease progression and guide treatment decisions across medical
specialties where genetic insights can significantly improve
patient care and lower healthcare costs. For more information,
visit www.myriad.com.
Safe Harbor Statement This press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including that
the granted patent will strengthen the company’s ability to deliver
a tumor-informed, high-definition, MRD assay to market, the company
believes the issued patent will help advance the company’s position
as a precision medicine leader—both via its own Precise MRD
offering and via potential licensing opportunities—in the MRD
space, the company believes that its unique set of capabilities
will enable it to profitably commercialize a MRD offering,
advancing oncology care for patients in this emerging
under-penetrated market, the company expects to have results from
its renal MRD study later this year, the company is on track to
process samples for biopharma partners by Q4’24 and to submit to
MolDx by year end, with a commercial launch targeted for the second
half of 2025, and the company expects to soon launch its Precise
Liquid test. These “forward-looking statements” are management’s
expectations of future events as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions, and events to differ materially and
adversely from those anticipated. Such factors include those risks
described in the company’s filings with the U.S. Securities and
Exchange Commission, including the company’s Annual Report on Form
10-K filed on February 28, 2024, as well as any updates to those
risk factors filed from time to time in the company’s Quarterly
Reports on Form 10-Q or Current Reports on Form 8-K. Myriad is not
under any obligation, and it expressly disclaims any obligation, to
update or alter any forward-looking statements, whether as a result
of new information, future events or otherwise except as required
by law.
Investor ContactMatt Scalo(801)
584-3532IR@myriad.com
Media ContactGlenn Farrell(385)
318-3718PR@myriad.com
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