Tag: HER2

Accuracy of HER2 Testing in Gastric Cancer

| April 5, 2015 | 0 Comments

With almost 1 million new cases per year, gastric cancer is currently the number four most common malignant disease. Today, there is no universal standard treatment. Recently, however, the ToGA trial demonstrated efficacy of Trastuzumab (Herceptin) for gastric and gastro-oesophageal (G/GEJ) patients who are over-expressing HER2. In 2010, the FDA approved Trastuzumab for treatment of […]

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Three Events – One Product Family! Join ASI in March!

| March 17, 2015 | 0 Comments

Three Events – One Product Family! Join Applied Spectral Imaging at the following events in March to learn about ASI’s GenASIs Platform. Accurate. Standardized. Immediate USCAP 2015 – United States & Canadian Academy of Pathology Annual Meeting March 23-25 | Hynes Convention Center, Boston, MA, USA | Booth # 519 ACMG 2015 – Annual Clinical […]

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Herlev University Hospital Selects ONCOtopix Dx for Routine Cancer Diagnostics

| March 9, 2015 | 0 Comments

After thorough testing, and internal clinical validation, Herlev University Hospital selects Visiopharm’s ONCOtopix™ Dx – a platform for computer assisted quantitative diagnostic immunohistochemistry (IHC) and In-Situ Hybridization (ISH). “Herlev University Hospital was the first diagnostic pathology lab in Denmark to adopt digital pathology and image analysis in routine clinical work. It has been important for […]

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Applied Spectral Imaging receives FDA Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67

| January 22, 2015 | 0 Comments

Carlsbad, CA. – January 21, 2015 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its GenASIs HiPath image capture and analysis platform. ASI’s GenASIs HiPath IHC Family is an advanced image analysis platform for IHC and CISH samples that integrates with existing lab […]

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Meet Visiopharm at ECP 2014 in London, UK

| August 27, 2014 | 0 Comments

Come meet Visiopharm August 30th – September 3rd in London, UK at the 26th European Congress of Pathology. Learn about our leading image analysis Quantitative Digital Pathology solutions for research and cancer diagnostics; utilizing our new Virtual Double Staining (VDS) methods with our TISSUEalign module. See a demonstration of our CE-IVD APPs for the breast […]

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ASI’s Webinar – July 29, 2014 – Register Now – Digital Pathology On Your Microscope

| July 25, 2014 | 0 Comments

ASI’s Webinar – July 29, 2014 – Register Now – Digital Pathology On Your Microscope A complete solution for FISH, CISH and IHC Applied Spectral Imaging Inc. develops computer aided image analysis & diagnostic tools for clinical and research applications. The GenASIs platform integrates within the existing workflow of the microscope, pathologist and LIS framework, […]

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ASI Looking for Clinical Validation Partners

| June 20, 2014 | 0 Comments

Clinical Validation Test for CISH Applied Spectral Imaging is recruiting a pathology lab to participate in a clinical validation study for HER2 CISH testing. The objective of this study is to evaluate the success of ASI’s GenASIs HiPath system to analyze breast tissue slides and measure the HER2 amplification degree on specimens stained with Ventana’s […]

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Register Now for Visiopharm Webinar: HER2 Protein Expression in Breast Cancer: Membrane Morphology and Accuracy with Regard to Gene Amplification

| June 9, 2014 | 0 Comments

Join Visiopharm for our webinar, “HER2 Protein Expression in Breast Cancer: Membrane Morphology and Accuracy with Regard to Gene Amplification” presented by Michael Grunkin, PhD the CEO and co-founder of Visiopharm. Date:     Monday, May 19, 2014 Time:     4:00 PM  CET/ 10 AM EST/ 7 AM PST Register at: https://www1.gotomeeting.com/register/308607449 or Date: Thursday, June 19, 2014 Time: […]

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Webinar from Visiopharm: HER2 Protein Expression in Breast Cancer: Membrane Morphology and Accuracy with Regard to Gene Amplification

| May 11, 2014 | 0 Comments

Join Visiopharm for our webinar, “HER2 Protein Expression in Breast Cancer: Membrane Morphology and Accuracy with Regard to Gene Amplification” presented by Michael Grunkin, PhD the CEO and co-founder of Visiopharm. Date:     Monday, May 19, 2014 Time:     4:00 PM  CET/ 10 AM EST/ 7 AM PST Register at: https://www1.gotomeeting.com/register/308607449 or Date: Thursday, June 19, 2014 […]

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Omnyx Receives FDA Clearance for Digital Manual Read of HER2 Pathology Slides

| April 14, 2014 | 0 Comments

PITTSBURGH – April 14, 2014 – GE Healthcare and UPMC today announced that the Omnyx™ Manual Read of the Digital HER2 Application has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance will allow the OmnyxTM system to be marketed in the U.S. for this intended use. Omnyx, LLC is a joint venture […]

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Philips receives FDA clearance for Digital Manual Read of HER2 pathology slides

| October 17, 2013 | 0 Comments

Philips introduces clinical digital imaging product for pathologists. 510(k) clearance from the US Food and Drug Administration (FDA) allows Philips to market its Her2/neu IHC Digital Manual Read product in the US. Pathologists can now use a digital system from Philips to help them assess treatment options for breast cancer patients. Royal Philips (NYSE: PHG, […]

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