Cancer Moonshot Initiative Could Launch Universal Companion Diagnostics, finds Kalorama

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Nov 09, 2016, 09:57 ET

ROCKVILLE, Md., Nov. 9, 2016 /PRNewswire/ -- Kalorama Information thinks that Obama "Cancer Moonshot" efforts to improve collaboration and information sharing between U.S. public and private sector researchers could also aid the development of universal companion diagnostic tests. Universal companion tests are sequencing-based assays could be used for the detection of a group or panel of disease-related gene mutations rather than mutation-specific tests. This was one of several findings made by the healthcare market research firm in a recent blog post looking at Moonshot impact on IVD markets. The firm covers companion markets in detail, in its large market research study Companion Diagnostic Markets. The report is available at: http://www.kaloramainformation.com/Companion-Diagnostics-10101302/.

"Current private sector efforts to develop universal companion diagnostics predominate in the area of oncology," said IVD market analyst Emil Salazar in a recent blog post. "While private companies have formed consortia for the development of universal companion diagnostics, the broad scope of such tests could also be supported by information from public sector primary research centers."

The Cancer Moonshot was announced by President Obama during his State of the Union address in January 2016. The initiative aims to promote cancer research through regulatory reform, increased National Institutes of Health (NIH) funding in targeted research areas, and improved collaboration between private and public sector researchers. Provisions of the initiative have been stalled or weakened by funding shortfalls, but progress to date made in regulatory reform and private sector collaboration. The initiative has already provided for the launch of the Blood Profiling Atlas pilot or an open database of liquid biopsies. Including the Blood Profiling Atlas project, the following are four leading projects for the development of a universal companion diagnostic test:

Next-generation sequencing leader Illumina agreed to deals in August 2014 with pharmaceutical companies AstraZeneca, Janssen Biotech and Sanofi for the development of a sequencing-based universal companion diagnostic test for use with cancer therapies.
Thermo Fisher Scientific entered into an agreement in September 2014 with GlaxoSmithKline (GSK) and Pfizer for the development of an NGS test with sequencing targets informed by the content of the Oncomine Cancer Research Panel. The universal CDx test could initially serve as an enrollment tool across drug programs before submission for FDA premarket approval as a test on Thermo's Ion Personal Genome Machine (PGM) Dx platform.
Foundation Medicine (majority-owned by Roche since 2015) has developed FoundationOne for solid tumors and Foundation One Heme for blood cancers. Both tests identify multiple gene mutations relevant to clinical trial enrollment and the efficacy of targeted cancer therapies. Foundation Medicine's long-term goal is the development of a universal companion diagnostic or highly multiplexed NGS assay for the identification of a spectrum of CDx or pharmacogenetics-related gene mutations.
The Blood Profiling Atlas project has 20 participants that will provide liquid biopsy study data for aggregation and sharing. Participants include AstraZeneca, Eli Lilly, Epic Sciences, Memorial Sloan Kettering Cancer Center, Foundation Medicine, Genentech (Roche), Guardant Health, Novartis, Personal Genome Diagnostics, Pfizer, Thermo Fisher Scientific, University of Michigan, and University of South California. Study data will be curated by a partnership between Open Commons Consortium, University of Chicago, and Seven Bridges.

Validation of universal companion diagnostic tests will also require unprecedented engagement with regulators. The U.S. FDA has yet to approve a multiplex or panel companion diagnostic test and would be thorough in its review of any such product due to companion diagnostics' high impact on patient outcomes. Over 100 oncogenes have been discovered and hundreds of cancer drugs are in development. Private sector-matched genes, drugs and cellular pathways will require coordinated regulator review already envisioned under the Center of Excellence. The future review and validation of universal or panel companion diagnostic tests will also draw from the consolidated expertise.

The entire blog post from Kalorama Information market analyst Emil Salazar can be found here: http://www.kaloramainformation.com/Content/Blog/2016/11/02/Moonshot-Initiative-Promotes-Next-Generation-of-Molecular-Cancer-Diagnostics.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

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