Summary

• Collaboration aims to enable personalized, highly effective therapies for each tumor type and enable early detection through screening and monitoring tests.
  
• Illumina data analytics platforms and collaborative lab services will enable more effective and efficient drug discovery by harnessing the power of genomics.

Originally published on LinkedIn

By Joydeep Goswami
Chief Strategy and Corporate Development Officer at Illumina

I’m proud to announce that today, during the World CDx Summit in London, Illumina, Inc. announced a long-term strategic collaboration with Janssen Biotech, Inc. (Janssen) to accelerate the development of precision medicines.

Illumina can help deliver precision medicine at scale

This is the first of what we expect will be many pharmaceutical strategic partnerships as the industry leverages the power of Illumina to create precision medicine at scale. Illumina brings four key attributes to such strategic CDx partnerships:

1. Enabling data-driven insights that drive innovative strategies for new drug target discovery using deep learning and AI-based genome interpretation tools such as PrimateAI, which leverages a dataset of human variants and over 300,000 common missense variants from six non-human primate species. Common missense variants in other primate species are largely clinically benign in humans, enabling pathogenic mutations to be systematically identified by the process of elimination. SpliceAI is another tool utilizing deep learning to identify splicing sites in noncoding regions of the genome with high accuracy.
   
2. Supporting innovation and discovery using whole-genome sequencing (WGS) and other multi-omic methodologies using Illumina Lab Services to deliver evidence in a hypothesis-supporting manner. Exploratory work on samples provided by pharma collaborators can unlock novel discoveries that improve human health.
   
3. Access to a formal CDx program aimed at therapeutic selection that can help doctors reach the intended patient population with precision therapies targeted at the unique biomarker in their tumor.
   
4. Global commercial reach through the largest install base of NGS instrumentation in the world.

As health care moves from a centralized diagnostic approach using large laboratories to run samples to a decentralized lab ecosystem with in-hospital and in-clinic diagnostic capacity, patient care teams will understand individual cancers faster and can begin precision therapies in days, not weeks.

Treatment for cancer should begin as soon as possible, but the current turnaround time for sample sequencing means many patients begin on standard-of-care treatment, which may close the door to precision therapies targeted to their unique tumor biomarkers.

As part of the collaboration, Illumina, together with Janssen, will co-develop CDx programs on Illumina’s TruSight™Oncology Comprehensive, 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, announced in March and first taking place in Europe, the in vitro diagnostic (IVD) comprehensive genomic profiling (CGP) kit will help inform precision medicine decisions for patients across the continent.

The collaboration will also explore the potential benefits of accessing Illumina’s new and cutting-edge technologies to develop a target discovery engine, which has the potential to support new drug and biomarker target discoveries.

The movement from comprehensive oncology panels to a multi-omic approach to diagnosis and treatment has been enabled by Illumina’s broad range of research products and network of partnerships, including:

• Our DRAGEN™ Bio-IT Platform, which provides accurate, ultra-rapid analysis of WGS data. The platform can process data for an entire human genome at 30× coverage in about 25 minutes.
  
• An agreement with SomaLogic to create an end-to-end proteomics solution on Illumina’s NGS platforms, which, combined with the scale and speed of our NGS technology. With the scale and speed of Illumina NGS technology, researchers can more effectively and efficiently make biological connections from genetic sequence (genotype) to cellular function (phenotype) and accelerate opportunities for clinical impact.
  
• A deal with Nashville Biosciences to map WGS data onto existing patient records in the system’s electronic health record (EHR) system using a de-identified data set of approximately 250,000 human DNA samples. This work can help better identify disease associations and intervention targets.

As Illumina’s Matt Nelson and Janssen’s Flora Berisha noted during their presentation on the opening day of the World CDx Summit, together we can do more. Precision medicine is a key component of pharma’s R&D strategy, and Illumina stands ready to support the development of precision diagnostics through our best-in-class portfolio of products across the oncology care continuum.

Use of forward-looking statements

This article 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 challenges inherent in developing, manufacturing, and launching new products and services, and our ability to successfully partner with other companies and organizations to develop new products, expand markets, and grow our business, 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.

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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. 

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