Pathology Artificial Intelligence (AI) as a Medical Device

September 10, 2018 – A pathology AI system with an intended use for clinical diagnostics (Dx), prognostics (Px) or companion diagnostics (CDx) can be commercialized as a medical device.

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Healthcare Big Data for Pathology

Aug 27, 2018 – Enabling Healthcare Big Data for Pathology requires moving from single-purpose, single-value pathology data to general-purpose rich information data for tissue.

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A Global Service Model for Tissue Image Analysis

Aug 13, 2018 – Tissue image analysis service providers need to have a thorough understanding of how to run a histology lab, Digital Pathology and Pathology AI in a regulated environment (e.g. CLIA, CAP, FDA single-site medical device in the US).

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DATA! = DATA…the dilemma when you have to choose a Tissue Image Analysis Technology

July, 30, 2018 – If you are a pharma or biotech company, a tissue bank, or a reference or specialty lab, how do you choose your tissue image analysis technology or service provider? Here are a few things to consider when choosing who you trust to get you the right data.

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A Primer on Artificial Intelligence in Pathology

July 15, 2018 – Over the past few years, deep learning has created quite a hype about artificial intelligence (AI), and healthcare AI has become a hot topic. To provide a better understanding of the different facets around pathology AI, we created a short video lecture series for a broad, non-technical audience.

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AACR Annual Meeting 2018 Recap

AACR’s Annual Meeting brings us the latest and best in cancer science and medicine from institutions all over the world. This year’s meeting, held earlier this month in Chicago, did not disappoint. A few of our key takeaways[…]

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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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