SAN DIEGO, Sept. 7, 2021 /PRNewswire/ -- Illumina, Inc.
(NASDAQ: ILMN) and Merck (known as MSD outside the United States and Canada) today announced a partnership to
develop and commercialize tests that identify genetic mutations
used in the assessment of homologous recombination deficiency
(HRD). Patients whose tumors are HRD-positive may be eligible for
targeted treatment by a class of precision medicines called PARP
inhibitors. The HRD tests will leverage Illumina's
TruSight™ Oncology 500 (TSO 500) content, enabling the
most comprehensive genomic profiling assays in a single
workflow.
This strategic partnership builds on an initial
study conducted with Merck and leverages Illumina's
relationship with Myriad Genetics (NASDAQ: MYGN) to expand
international access to the proprietary technology in Myriad's FDA
approved myChoice® CDx companion diagnostic test. Illumina
will develop a new HRD CDx test for the EU and the UK to aid
in the identification of ovarian cancer patients with positive HRD
status who are eligible for treatment with LYNPARZA® (olaparib), a
first-in-class PARP inhibitor, jointly developed and commercialized
by Merck and AstraZeneca.
In addition, Illumina will develop and commercialize a research
use only (RUO) HRD assay that will be add-on content for the TSO
500 RUO panel. Illumina plans to launch this product globally,
excluding the United States and
Japan.
"With such great advances in precision medicine being made by
companies such as Merck, it's essential that patients who would
benefit from LYNPARZA are identified," said Joydeep Goswami, Chief Strategy and Corporate
Development Officer of Illumina. "By leveraging our comprehensive
genomic profiling family of products, TruSight™ Oncology, and the
gold standard myChoice® HRD technology, Illumina aims to offer
the best-in-class HRD assay that is broadly accessible. By
harnessing the incredible medicines development expertise of
Merck, together we will be able to leverage the use of precision
medicines to make a real difference for patients."
"HRD testing should be an essential component of clinical
diagnosis as half of all newly diagnosed patients with advanced
ovarian cancer have HRD-positive tumors," said Dr.
Eric H. Rubin, senior vice
president, early-stage development, clinical oncology, Merck
Research Laboratories. "Biomarker testing has rapidly enhanced our
understanding of how PARP inhibition can help target a devastating
disease, like ovarian cancer and we are excited to partner with
Illumina on the development of a distributed CDx HRD assay for the
EU and UK."
This collaboration with Merck expands on Illumina's solid
history and broad portfolio of oncology partnerships with industry
leaders, with the united goal of advancing cancer diagnostics and
precision medicine.
About TruSight Oncology 500
TSO 500 is a Research Use Only pan-cancer assay that enables
Comprehensive Genomic Profiling. Designed to identify known
and emerging tumor biomarkers across 523 genes, TSO 500 utilizes
both DNA and RNA from tumor samples to identify key variants
critical for cancer development and progression, such as small DNA
variants, fusions, and splice variants. In addition, the assay
assesses key immune-oncology biomarkers, such as Tumor Mutational
Burden (TMB) and Microsatellite Instability (MSI). Due to its
comprehensive biomarker content, labs can consolidate multiple
single gene or small panel workflows into a single assay, saving
biopsy specimen and time. Based on the content of TSO 500, Illumina
will be adding an in vitro diagnostic (IVD) test
to the TSO product family. This comprehensive tumor profiling assay
will have similar chemistry and analytics to TSO 500. To learn more
about TSO 500, click here.
About Myriad Genetics and myChoice® CDx
Myriad Genetics is a leading genetic testing and precision
medicine company dedicated to improving health and well being for
all. Myriad's myChoice CDx companion diagnostic test is the
first and only FDA-approved tumor test that determines homologous
recombination deficiency status by detecting BRCA1 and BRCA2
(sequencing and large rearrangement) variants and assessing genomic
instability using three critical biomarkers: loss of
heterozygosity, telomeric allelic imbalance and large-scale state
transitions. It has been referred to as "The most comprehensive
Tumor test to determine HRD status in patients with ovarian
cancer." To learn more about myChoice CDx, visit
https://myriad-oncology.com/mychoice-cdx/.
About Illumina
Illumina is improving human health by unlocking the power of the
genome. Our focus on innovation has established us as the global
leader in DNA sequencing and array-based technologies, serving
customers in the research, clinical and applied markets. Our
products are used for applications in the life sciences, oncology,
reproductive health, agriculture and other emerging segments. To
learn more, visit www.illumina.com and connect with us
on Twitter, Facebook, LinkedIn, Instagram,
and YouTube.
Use of forward-looking statements
This release contains forward-looking statements that involve
risks and uncertainties, including the expectation for lower costs
related to the storing and managing of genomic data costs. Among
the important factors that could cause actual results to differ
materially from those in any forward-looking statements are: (i)
challenges inherent in developing and launching new products and
services; (ii) our ability to deploy new products, services, and
applications, and to expand the markets for our technology
platforms; and (iii) the acceptance by customers of our newly
launched products, which may or may not meet our and their
expectations once deployed, together with other factors detailed in
our filings with the Securities and Exchange Commission, including
our most recent filings on Forms 10-K and 10-Q, or in information
disclosed in public conference calls, the date and time of which
are released beforehand. We undertake no obligation, and do not
intend, to update these forward-looking statements, to review or
confirm analysts' expectations, or to provide interim reports or
updates on the progress of the current quarter.
Investors:
Brian Blanchett
858.291.6421
IR@illumina.com
Media:
Dr. Karen Birmingham
EMEA: +44 7500 105665
US: 646.355.2111
kbirmingham@illumina.com
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SOURCE Illumina, Inc.