The Well-Designed Study: How Validated Biomarker Measurements are Supporting Clinical Endpoints

It is no secret that drug developers are under increasing pressure to discover new targeted therapies to meet high unmet medical needs, and to design clinical trials that will minimize the risk of failure to gain commercial approval[…]

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The “One Number” Promise Insights from the Next Generation Dx Summit Highlight the Need for Integrated, Unified and Actionable Data

Twenty years ago, the foundation for Next-Gen Sequencing was set. Ten years ago, advances made NGS a viable platform. Today, clinicians are just starting to use the platform for clinical benefit. It takes a long time to bring a new platform to market. NGS is just one of many that are emerging to advance clinical practice[…]

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Tumor Agnostic Approval Signals New Phase for Precision Medicine

In an important first, the FDA recently granted accelerated approval to Keytruda® for an indication that is based on a common biomarker rather than a tumor type. This approval signals a new phase in precision medicine and a potential major shift in the approach to cancer treatment[…]

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WSI System clearance for primary diagnosis expands clinical application of digital pathology

On April 12, 2017, FDA granted marketing clearance for the Philips IntelliSite Pathology Solution (PIPS), the first Whole Slide Imaging (WSI) System cleared for use in primary disease diagnosis. As the first WSI system authorized for this purpose, the clearance represents a turning point in the adoption of digital pathology methods in clinical laboratories by enabling the use of WSI systems in routine pathology workflows[…]

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Combining Genomic Profiling and Tissue-Based Biomarker Assays to Aid in the Early Detection and Prevention of Cancer

Genomic sequencing of precancerous lesions to improve prevention and early detection of cancer was a major focus at the recent American Association of Cancer Research (AACR) annual meeting.

With new immunotherapy targets continuing to emerge, and with the ongoing development of combination therapies, including targeted therapies, chemotherapy, radiation therapy, and checkpoint inhibitors, understanding the stromal components and immune infiltrates in tissue may be key to enabling a precise and targeted therapeutic strategy for cancer prevention and early intervention[…]

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The Role of cTA™ In Bringing IO 360° Full Circle

The 3rd annual Immuno-Oncology 360° meeting, #IO360nyc, took a 360-degree view of the IO space with the first day dedicated to science, the second to clinical data, and the third to the “business” landscape. 

With over 800 clinical trials in process for combination IO therapeutics and almost no holds for toxic events, it is estimated that approximately 80 FDA approvals will be issued over the next two to four years[…]

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