Tag: FDA

Advisory Board Applauds On-Demand Approach of OptraSCAN

| July 19, 2017 | 0 Comments

OptraSCAN has given tissuepathology.com a rare insight into their advisory board discussions as to what their thought leaders think is important in the digital pathology space for the market. OptraSCAN is of course the first On-Demand digital pathology company that includes a small footprint, high and low throughput WSI scanner OptraSCANTM (that facilitates brightfield, fluorescent and frozen section/live view scanning), […]

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Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

| July 9, 2017 | 0 Comments

Promega Corporation intends to seek FDA approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions. The current Promega Research Use Only MSI Assay has been available and used in the market as part of Lab-Developed Tests since 2004 and is considered the […]

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Q&A with Philips Digital Pathology

| June 23, 2017 | 0 Comments

I recently had an opportunity to speak with Esther Abels, Director of Regulatory, Clinical and Medical Affairs for Philips Digital Pathology Solutions about Philips’ recent approval to market their Philips Intellisite Pathology System (PIPS) for primary diagnosis of biopsies and excisions in the United States. My thanks to Esther and Philips’ marketing team for their […]

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FDA Approval of Immunotherapy For MSI-High or Mismatch Repair Deficient Tumors

| June 5, 2017 | 0 Comments

Last month the FDA approved pembrolizumab (KEYTRUDA) for adult and pediatric patients with with metastatic or unresectable, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment. KEYTRUDA has also been approved fro MSI-H or dMMR colorectal cancers that have progressed following treatment with conventional chemotherapies. The immunooncology/immunotherapy story is fascinating. […]

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What does FDA Approval Mean for the Digital Pathology Market? Part 1

| May 15, 2017 | 0 Comments

Much is being said, written and discussed about the recent FDA clearance for Philips digital pathology solution for primary surgical pathology diagnosis. Of course, this means an advantage for Philips right now in the market as the only FDA approved whole slide imaging system for primary diagnosis. For groups and hospitals that appreciate the two main […]

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Webinar: Philips IntelliSite Pathology Solution Now Available for Primary Diagnostic Use in the U.S.

| April 30, 2017 | 0 Comments

Thu, May 4th, 2017 11:00 AM EST (1 hour) As a leader in the field, Philips is a driver of the adoption of digital pathology. Our solution was developed with the aim to increase efficiency and collaboration in your clinical lab. We are very proud to announce the Philips Intellisite Pathology Solution is the first, […]

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162 Days of Change

| April 17, 2017 | 1 Comment

As of last Thursday, April 12, 2017 and going back to a rainy night in Cleveland on November 2, 2016, the past 162 days have seen at least 3 things most Americans, and perhaps many across the world thought they would never see happen in their lifetimes. That rainy night in Cleveland started the clock […]

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FDA Allows Marketing of First Whole Slide Imaging System for Digital Pathology

| April 13, 2017 | 1 Comment

Welcome news anticipated from FDA for some time with recent Philips submission for approval. Philips Intellisite Pathology Solution (PIPS) first WSI system approved with special controls on the system to insure patient safety. More to follow on FDA approval of WSI for clinical use! The U.S. Food and Drug Administration today permitted marketing of the […]

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Inspirata Seeking Senior Vice President, Cancer Diagnostics Software Products

| March 27, 2017 | 0 Comments

The Sr. Vice President—Cancer Diagnostics Software Products should be a highly-experienced business leader with exceptional deep knowledge and understanding of digital image processing software domain and proven sales and marketing experience. This leader will be responsible for the execution of the company’s business strategy for the cancer diagnostics software algorithm business unit including regulatory and […]

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FDA Delays Final Guidance on Regulating LDTs

| November 25, 2016 | 0 Comments

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA […]

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Multi-Center Clinical Validation Study by Philips to be Submitted to FDA in Support of Expanded Indications for Use for Philips IntelliSite Digital Pathology Solution in the U.S.

| October 24, 2016 | 0 Comments

Great news from Philips who announced on October 21st their completion of a glass versus digital concordance study to be submitted to FDA.  The press release mentions 2,000 cases with approximately 16,000 reads. The press release goes on to say that the final discordance rate was 1%. Philips will submit the results of the study along […]

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FDA Approves First Liquid Biopsy Test for Use in Non-Small Cell Lung Cancer

| June 1, 2016 | 0 Comments

Exciting news today from FDA with news of approval of first liquid biopsy test for use in non-small cell lung cancer.  The cobas EGFR test is already approved for use in formalin-fixed paraffin-embedded (FFPE) tissue. This new use is intended for detection of these specific mutations in circulating-free tumor DNA (cfDNA) from plasma for first […]

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FDA Grants Accelerated Approval to Nivolumab in Classical Hodgkin Lymphoma

| May 17, 2016 | 0 Comments

More interesting news around PD-L1 for use in Classical Hodgkin lymphoma with specific indications as below. Another increasingly common example of companion diagnostics and personalized immunotherapies. On May 17, 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma that has […]

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FDA Technical Guidance Document Does Not Go Far Enough

| May 13, 2016 | 0 Comments

As many readers are aware, on April 20th the FDA released its Technical Guidance Document for Digital Pathology Whole Slide Imaging Devices after draft proposal/review from February of last year. Given its title, this is a technical document, obviously. However, in my opinion, the document, beginning with draft to this finished product, I am sure despite comments to […]

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