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June 2020 – Innovation & Growth Drive the NGS Clinical Diagnostic Industry

Next-generation sequencing (NGS) clinical diagnostic labs are playing a key role in efforts to assess the spread of the COVID-19 virus and to develop a vaccine and therapeutics. At the same time, they continue to collaborate and innovate, develop breakthroughs, and advance patient outcomes. In this post, we look at a few standout examples.

Exciting Partnerships & Collaborations Driving Change

Over the last several months, we’ve seen a number of announcements for new partnerships and collaborations between laboratories and other life sciences organizations. Each one combines clinical diagnostic skill and subject-matter expertise with new technologies to extend industry knowledge, reduce costs, and improve patient outcomes.

Illumina, a leading developer of life science tools and integrated systems for large-scale analysis of genetic variation and function, recently announced a new 15-year collaboration with Roche. The partnership aims to accelerate the adoption of distributable NGS-based in-vitro diagnostic tests in oncology. The two companies also plan to work together on new companion diagnostic claims to complement Illumina’s pan-cancer assay TruSight Oncology 500. What’s exciting about this new joint effort is the potential it offers for both broadening patient access to genomic testing and transforming cancer risk prediction, detection, diagnosis, treatment, and monitoring.

Guardant Health, a leading precision oncology company, has partnered with Amgen to develop Guardant360®, a global liquid biopsy companion diagnostic for AMG 510, an investigational oral therapy that inhibits the KRAS G12C mutant protein in metastatic non-small cell lung cancer (NSCLC) patients. AmirAli Talasaz, Guardant Health President, believes that developing the Guardant360 companion diagnostic will “ultimately increase the number of patients who are identified as eligible for targeted therapies, including AMG 510, and thus improve access to these potentially life-changing treatments.” Replacing a one-size-fits-all approach to treating cancer with targeted therapeutics is likely to have a huge impact on patients’ quality of life and outcomes.

Personal Genome Diagnostics, a leader in cancer diagnostics, has reported that they will be collaborating with Eisai to develop a comprehensive liquid biopsy biomarker discovery solution. Their goal is to enable researchers and biopharma companies to gain genomic insights into the molecular evolution of tumors throughout a treatment course—without the need for invasive and resource-intensive serial tissue biopsies. Personal Genome Diagnostics is also partnering with the Mayo Clinic to optimize technology and clinical utility studies for liquid biopsy and tissue-based genomic applications.

Researchers from Helix, a population genomics company, and Renown Health joined forces on the largest-ever genome-wide rare variant analysis on thousands of clinical phenotypes and over 70,000 exomes. The study highlights the importance of using both deep and broad next-generation sequencing assays for discovering gene-based associations, and the benefits of data-analytics platforms for uncovering insights from large-scale datasets. You can learn more about their research at Nature Communications.

C-Suite & Board Additions

We’ve also seen a slew of C-suite and board changes that recognize the central importance of the business aspects of clinical digital laboratories. For example, Guardant Health recently appointed high-tech veteran Kumud Kalia as their Chief Information Officer to lead the company’s enterprise applications, information technology, and security teams. This addition highlights the value the company places on its software and digital solutions in planning for growth.

Another notable appointment is Dr. Scott Gottlieb to Illumina’s Board of Directors. Dr. Gottlieb is a former US Food and Drug Administration (FDA) Commissioner. At the FDA, he advanced the agency’s Oncology Center for Excellence and helped implement the 21st Century Cures Act. He also helped make the regulatory process for the development and review of novel drug and medical devices more efficient, including the approval of the first gene-therapy-based cancer treatments. Francis deSouza, Illumina’s Chief Executive Officer, said, “Illumina will benefit from Scott’s expertise in healthcare and public policy as we work to accelerate the adoption and impact of genomics into the standard of care in oncology, reproductive health, and other clinical areas.”

Mergers & Acquisitions

In Mergers and Acquisitions news, we were excited to see the announcement that Invitae, a leading medical genetics company, plans to acquire YouScript and Genelex. Their goal is to make it easier to use pharmacogenetic data—information on genetic variations that can impact how an individual responds to prescription medication—at the point of care. Peer-reviewed studies indicate that using YouScript’s clinical decision-making support software with Genelex pharmacogenetic testing can reduce adverse events, costs, and hospital readmissions. That’s certainly a win for everyone from patients, to healthcare providers, to payers. Also, as Sean George, co-founder and chief executive officer of Invitae, says, it’s an exciting step toward bringing comprehensive genetic information into mainstream medical care.

The integration of heterogeneous software systems required to run a modern NGS laboratory presents challenges for companies when privacy policies meet collaboration. This is most evident in the organizations that eschew the software and ontological work necessary to make their data findable, accessible, interoperable, and re-usable. Companies that prioritize this work can better leverage the promise of ground-breaking collaboration.

If you want to learn how Semaphore can help your laboratory transition to a software solution that enables collaboration with ecosystem partners, contact us today.

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