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A spotlight on CDx development
June 23, 2020
NeoGenomics will share several posts focusing on CDx development. We will be launching an occasional updated blog covering our thoughts, musings, and opinions on personalized medicine.Or other topics…
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AACR 2024: Drug Targets, part-1
May 3, 2024
Margaret Foti, PhD, MD, chief executive officer of the American Association for Cancer Research (AACR), kicked off this year’s opening ceremony celebrating an outstanding year for the organization.…
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AACR 2024: Spatial Biology, part-2
May 10, 2024
Spatial biology is an ever-evolving discipline focusing on improving our understanding of biological processes within the context of spatial organization, such as how cells are arranged within…
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Advancements in the Treatment of Glioblastoma Using Oncolytic Viruses
July 3, 2023
While current oncology research is revealing both diagnostic and prognostic markers as well as predictive cell states, and identities with implications for drug…
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Being Comprehensive in Hematologic Malignancies
December 3, 2019
The need for comprehensive testing seems obvious in the context of working up most cases of hematologic malignancies. However, there is still a perception gap amongst oncology…
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Being hit by a TRuC can be a good thing:
August 23, 2023
Author: Kirsteen Maclean Ph.D.
Over the past decade cellular therapies have transformed the field of oncology, offering new hope to cancer patients. With its ability to activate and…
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Biomarker Types and CDx Biomarkers
April 29, 2021
The field of precision medicine is rooted in biomarker guided therapy. These biomarkers come in various forms as well as are categorized depending on use cases. Within oncology where nearly all…
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CAR-T Cell Therapy in Oncology Applications
June 28, 2023
Cell and gene therapies present an entirely new paradigm in drug development. Among these therapies, Chimeric Antigen Receptor (CAR)-T cell therapy has proven to be a game-changer in the…
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Case Study: How Pharma Uses NeoGenomics Real-World Oncology Data to Accelerate Biomarker Adoption and Commercial Launch
November 1, 2022
Biomarker testing is critical for ensuring that cancer patients get the right…
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Comprehensive Genomic Profiling (CGP) expands precision medicine’s utility
July 4, 2022
With the first TKI therapy Imatinib (Gleevec) targeting the fusion BCR-ABL1, approved by FDA in 2001, we have witnessed the birth of modern targeted therapy…
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CRO and Clinical Reference Laboratory Commercial Incentives
January 4, 2021
One of the challenges developing a companion diagnostic is creating a test that runs well in both clinical trials, and following regulatory approval, clinical testing…
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Diagnostic Symposium
May 6, 2022
Join NeoGenomics for our upcoming Diagnostic Symposium on Tuesday, May 10, 9 to 10 a.m. PT. Learn from industry-leading thought leaders during this one-hour session on "Co-targeting Driver Pathways: Efficacy and…
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Enabling Precision Medicine for Breast Cancer Patients
October 19, 2021
Approximately every 2 minutes, a woman in the U.S. is diagnosed with breast cancer1. This high prevalence has led to rigorous standards of practice, from diagnosis to…
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Entering the Multi-omics and precision medicine era in cancer research
February 3, 2022
Why multi-omics?
Cancer hallmarks typically incorporate complex phenotypic and molecular changes including uncontrolled and sustained proliferation, evading…
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Expert approaches to resolving challenging areas in diagnostic pathology
April 10, 2019
The past decade has seen considerable diagnostic advances distinguishing classic Hodgkin lymphoma (CHL) from other lymphoma mimics. Currently, because of…
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FedEx Express National Service Disruption: Severe Winter Weather
December 23, 2022
FedEx Express experienced substantial disruptions at their Memphis and Indianapolis hubs last night due to severe winter weather that has been moving across the…
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First CDx Approval for HLA Typing
March 8, 2022
We have seen HLA typing become more prominent in oncology clinical studies. Especially in the realm of immuno-oncology therapeutics including CAR T-cells, bi-specifics, and cancer vaccines. I…
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Genomics in Precision Medicine
July 14, 2021
We often hear “Don’t take anything personally”. However, that is not the case in terms of precision medicine. In 2015, the U.S. government launched the "Precision Medicine Initiative". Since then,…
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How does medical purpose drive regulatory requirements in EU clinical trials?
January 9, 2023
Clear and accurate assessment of whether use of an assay in a clinical trial assay is considered exploratory or an “IVD” is necessary as implications…
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Improving Diagnosis of Barrett’s Esophagus
September 19, 2019
Esophageal cancer, while relatively uncommon, has risen dramatically over the past several decades. Currently it is the sixth most common cause of cancer deaths worldwide and its…
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Is IHC going to exhaust our archival blocks the way single gene testing used to?
October 25, 2022
Over the past year we have seen unprecedented demand for IHC assay development services with the goal of creating a prototype CDx assay. These…
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Is It Validated?
August 11, 2020
NeoGenomics has a menu of >600 assays across many different technologies and approaches. Clients often approach us after searching our menu online and ask if we can “Provide Test X for Clinical Trial Y.”…
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ISO 15189 accreditation of the Swiss and Singapore NeoGenomics sites
February 24, 2022
In 2020 NeoGenomics decided to launch an accreditation program for its international sites in Switzerland and Singapore.
Clarity on the need to be ISO 15189…
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It’s a Great Clinical Trial Assay
November 11, 2020
While there are many great tools and technologies available to support drug development, the number of platforms used for CDx development remains very limited. Looking at the FDA CDx approvals…
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IVDR at NeoGenomics
October 4, 2022
With the recent application of IVDR on May 26, 2022, there are new regulatory standards that oversee the sales and use of IVDs for the EU. As with any new regulation, there’s been a scramble to properly…