Veracyte Announces In Vitro Diagnostic Agreement with Illumina to Broaden Availability of Its Tests for Patients Globally
November 07 2023 - 3:00PM
Business Wire
Agreement is part of Veracyte’s multi-platform
strategy for its decentralized IVD tests outside of the U.S.
Veracyte, Inc. (Nasdaq: VCYT) today announced that it has
entered into a multi-year agreement with Illumina, Inc. (Nasdaq:
ILMN) to develop and offer some of its high-performing molecular
tests as decentralized in vitro diagnostic (IVD) tests on
Illumina’s NextSeq 550Dx next-generation sequencing (NGS)
instrument. The agreement is part of Veracyte’s expanded,
multi-platform IVD approach, which will also include qPCR and is
designed to accelerate the company’s ability to make its tests
available to more patients globally.
"By expanding our IVD strategy to include established NGS and
qPCR technologies, we believe we can help even more physicians and
patients make better diagnostic and treatment decisions using our
tests," said Marc Stapley, Veracyte’s chief executive officer.
"With its significant and growing installed base of NGS IVD
instruments, Illumina is a natural partner to help us achieve our
vision of transforming cancer care for patients all over the
world."
The first tests that Veracyte plans to develop for the Illumina
NextSeq 550Dx instrument are its Prosigna Breast Cancer Assay and
Percepta Nasal Swab test. Prosigna is already commercially
available as an IVD test that helps inform treatment decisions for
patients with early-stage breast cancer. The noninvasive Percepta
Nasal Swab test is intended to help guide diagnosis and treatment
decisions for current and former smokers with lung nodules that are
potentially cancerous.
“We are pleased to partner with Veracyte, with its
high-performing tests in some of the world’s most prevalent
cancers, to expand the reach of NGS-based molecular testing in
cancer care,” said Joydeep Goswami, chief financial officer and
chief corporate development and strategy officer of Illumina. “We
believe that enabling hospitals and laboratories to perform
advanced molecular testing locally will significantly broaden
market access and enable faster turnaround times so that patients
and physicians can make better informed and timely decisions.”
Illumina’s NextSeq 550Dx instrument offers a validated
mid-throughput platform and provides access to an ever-expanding
pipeline of clinical applications in the fields of oncology,
reproductive health, genetic diseases testing, and more. With
regulatory approvals in over 60 countries, NextSeq 550Dx has become
a trusted platform for hospitals and clinical laboratories running
a menu of high-quality diagnostic tests.
Veracyte is also developing its Decipher Prostate Genomic
Classifier, currently available in the United States through its
CLIA laboratory, as a qPCR-based test for use outside of the
U.S.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose
vision is to transform cancer care for patients all over the world.
We empower clinicians with the high-value insights they need to
guide and assure patients at pivotal moments in the race to
diagnose and treat cancer. Our high-performing tests enable
clinicians to make more confident diagnostic, prognostic, and
treatment decisions for some of the most challenging diseases such
as thyroid, prostate, breast, bladder and lung cancers, as well as
interstitial lung diseases. We help patients avoid unnecessary
procedures and speed time to diagnosis and appropriate treatment.
In addition to making our tests available in the U.S. through our
central laboratories, we also aim to deliver our tests to patients
worldwide through a distributed model to laboratories that can
perform them locally. For more information, please visit
www.veracyte.com and follow the company on Twitter (@veracyte).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to our statements related to our plans,
objectives, expectations (financial and otherwise) or intentions
with respect to our clinical tests in and outside of the United
States. Forward-looking statements can be identified by word as:
“appears,” "anticipate," "intend," "plan," "expect," "believe,"
"should," "may," "will," “positioned,” “designed” and similar
references to future periods. Examples of forward-looking
statements include, among others, that this expanded platform
strategy, including through the use of Illumina’s NextSeq 550Dx,
will accelerate the company’s ability to make its tests available
to more patients globally; that with this strategy, Veracyte can
help even more physicians and patients make better diagnostic and
treatment decisions using our tests; and that enabling hospitals
and laboratories to perform advanced molecular testing locally will
significantly broaden market access and enable faster turnaround
times patients and physicians can make better informed and timely
decisions. Additional factors that may impact these forward-looking
statements can be found under the caption “Risk Factors” in our
Annual Report on Form 10-K filed on March 1, 2023, and our
Quarterly Report on Form 10-Q filed for the three months ended June
30, 2023. Copies of these documents, when available, may be found
in the Investors section of our website at
https://investor.veracyte.com. These forward-looking statements
speak only as of the date hereof and, except as required by law, we
specifically disclaim any obligation to update these
forward-looking statements or reasons why actual results might
differ, whether as a result of new information, future events or
otherwise.
Veracyte, the Veracyte logo, Prosigna and Percepta are
registered trademarks of Veracyte, Inc. and its subsidiaries in the
U.S. and selected countries.
The Percepta Nasal Swab test and the Decipher Prostate Genomic
Classifier are available in the US as part of Veracyte’s
CLIA-validated laboratory developed test (LDT) service. These tests
have not been cleared or approved by the FDA.
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Veracyte Contacts
Investors: investors@veracyte.com 619-393-1545
Media: Tracy Morris VP of Global Corporate Communications
tracy.morris@veracyte.com 650-380-4413
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