Illumina Unveils Groundbreaking Comprehensive Genomic Profiling Test for Cancer in Europe

 The single in vitro diagnostic test helps inform therapy decisions according to clinical guidelines to enable precision medicine earlier in the disease journey

SAN DIEGO, March 15, 2022 /PRNewswire/ -- Illumina, Inc. (NASDAQ:ILMN) today announced the launch of TruSight™ Oncology (TSO) Comprehensive (EU), a single test that assesses multiple tumor genes and biomarkers to reveal the specific molecular profile of a patient's cancer.  With its global launch first taking place in Europe, the in vitro diagnostic (IVD) kit will help inform precision medicine decisions for cancer patients across the continent.

This new in vitro diagnostic (IVD) comprehensive genomic profiling (CGP) kit covers a broad range of mutations and current and emerging biomarkers associated with the European Society for Medical Oncology guidelines, drug labels and clinical trials, maximizing the chances of finding actionable information from each patient's biopsy. Conventional tests, such as single biomarker tests and targeted hotspot panels, are limited in the number of targets they analyze which increases the chances of missing critical information.

"This groundbreaking and accurate diagnostic kit provides information clinicians can use to help match their patients to available therapies according to clinical guidelines or clinical trials, based on their tumor profile," says Kevin Keegan, General Manager for Oncology at Illumina. "At Illumina we are proud to be bringing innovations like this to market, and to be at the forefront of unlocking the power of the genome for human benefit."

TSO Comprehensive (EU) assesses biomarkers in 517 cancer-relevant genes across nearly 30 solid tumor types by evaluating both DNA and RNA, and complex genomic signatures, such as microsatellite instability (MSI) and tumor mutational burden (TMB). This comprehensive assessment eliminates the need for running separate, sequential gene tests from multiple biopsy procedures. The fast turnaround time of four to five days for sample-to-clinical report generation, versus weeks in some cases, enables clinicians to make decisions regarding personalized medicine or clinical trial enrollment for their cancer patients.

"The most pressing challenge we face in profiling biomarkers from tumor samples is the ability  to keep up with the pace of new biomarkers linked to new therapies and clinical trials," says Rhian White, Consultant Clinical Scientist at the All Wales Medical Genomics Services, Cardiff, UK. "We need a testing platform that can assess all these biomarkers, while at the same time preserving limited biopsy specimen. Comprehensive genomic profiling has proven to be this platform."

TSO Comprehensive (EU) is the first CE (Conformité Européenne)-marked IVD kit for CGP based on DNA and RNA content, having met important European standards for quality and efficacy.  The CE-mark is a pre-requisite for reimbursement of diagnostic tests by health authorities, and in some European countries, is required before laboratories can use a new testing method. As a validated, CE-marked IVD, and a kitted solution, the introduction of TSO Comprehensive (EU) provides a streamlined process for use in-house by any pathology lab, so that testing can be offered closer to patient care.

"Clinicians are increasingly matching the genetics of a patient's cancer with their therapy," explains Phil Febbo, MD, Chief Medical Officer at Illumina. "When a medical center internalizes comprehensive genomic profiling of cancer, the multidisciplinary team includes a molecular pathologist who has more control over the biopsy sample and data generated, and can increase the number of informed cases they are able to deliver. Evidence suggests when this happens, more patients have access to CGP and precision medicine earlier on in their disease journey."

Illumina has a growing pipeline of companion diagnostics (CDx) claims under development, through partnerships with pharma companies, which will be added to TSO Comprehensive (EU) over time following regulatory approval. These CDx solutions will help unlock groundbreaking targeted therapies and immunotherapies to make a difference to the lives of cancer patients. As Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, the company aims to advance cancer diagnostics and precision medicine.

About TSO Comprehensive
TruSight™ Oncology Comprehensive is an in vitro diagnostic test that uses targeted next generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina® NextSeq™ 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.
 
The test is intended to provide tumor profiling information for use by qualified healthcare professionals in accordance with professional guidelines and is not conclusive or prescriptive for labeled use of any specific therapeutic product. To learn more about TruSight Oncology comprehensive , click here:  www.illumina.com/tsocomprehensive?scid=2022-270PR5798

Use of forward-looking statements
This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing, manufacturing, and launching new products and services, including expanding or modifying manufacturing operations and reliance on third-party suppliers for critical components; (ii) our ability to obtain approval by third-party payors to reimburse patients for our products; (iii) legislative, regulatory and economic developments, 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.

About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a 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.

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