Tissue Phenomics Blog

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Topics:  companion diagnostics, precision medicine, IVD, LDT, CDx strategy

Does it always take an IVD to be a CDx

Jul 10, 2017 7:30:00 AM

From the dawn of the Precision Medicine Age, pathologists have relied upon in vitro diagnostics (IVDs) to inform treating physicians of possible therapy options for cancer patients. From tests for HER2, EGFR, KRAS, and other biomarkers, IVDs have been more than sufficient to generate the necessary information to enable physicians to make educated treatment decisions. However, in the last few years, two pharmaceutical companies have successfully launched a drug with a sole-source lab commercializing a laboratory developed test (LDT). The first was AstraZeneca launching Lynparza™ requiring the use of Myriad Genetics’ BRACAnalysis CDx™ in December 2014, and the second was Clovis Oncology launching Rubraca™ requiring the use of Foundation Medicine’s FoundationFocus™ CDxBRCA in December 2016. It is still too early to know whether or not launching a CDx as a LDT is a new and sustainable trend, but it begs the question: Why would a pharma company select a lab as a CDx partner over an IVD manufacturer?

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Topics:  personalized medicine, companion diagnostics, reimbursement, market access, quantitative IHC

Enabling Market Access for Quantitative IHC-Based Companion Diagnostics

Jun 5, 2017 6:00:00 AM

The complexity of the tumor microenvironment represents a significant challenge to the personalized medicine movement in the field of oncology. While genetic and genomic analyses enable an understanding of the patient’s genotype, this does not necessarily translate to active tumor microenvironment expression – phenomics – through which pharmacodynamic pathways are modulated by targeted therapies. Similarly, while single biomarker immunohistochemistry (IHC) can effectively quantify expression of a particular biomarker, it fails to evaluate the entire picture of the tumor microenvironment, where a myriad of potentially confounding factors exists to distort the causal relationship between expression of a single marker and treatment response. 

Enter context-based analysis of biomarker expression – quantitative, multiplex IHC technology leveraging “big data” capabilities to overcome the inherent limitations of existing diagnostic techniques and more precisely assess the tumor microenvironment. Applied as a companion diagnostic (CDx), quantitative IHC or IF (qIHC/IF) using image analysis (IA) technology represents a potentially paradigm-shifting approach to predict patient response to oncologics and thus bring the movement of personalized medicine to fruition. Read More

Topics:  image analysis, personalized medicine, biomarker, immuno-oncology, tissue diagnostics, companion diagnostics, tissue biomarkers, diagnostics, diagnostic test, precision medicine, biomarker signature

3 ways tissue image analysis will shape the future of cancer treatment with immunotherapies

Nov 7, 2016 1:00:00 AM

As healthcare continues its transition towards precision medicine, physicians are eager to maximize both the quantity and quality of data obtained from their patients’ tissue samples.  In the current “one drug, one test” paradigm, physicians struggle to balance the number of tests required to make a treatment decision with the limited amount of tissue that is available.  Further complicating treatment decisions is the use of imperfect biomarkers associated with targeted therapies, as the patients who are identified to be ideal candidates for a targeted therapy respond only some of the time while patients who are not expected to respond do.  This dilemma is of great concern for those who are responsible for paying for these expensive therapies - payers and patients – who would like to avoid unnecessary expenses for drugs that may not work and possibly cause debilitating side effects.  Of course, of even greater concern is helping the patient identify the best therapeutic option that allows them the best opportunity to treat their disease and maximize their quality and quantity of life.

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Topics:  personalized medicine, companion diagnostics, Companion Diagnostic Development, biomarker datafication, patient stratification, Biomarker Datafication Services

Powerful, Data Driven Patient Stratification - Improving biomarker performance.

Aug 26, 2015 8:00:00 AM

Personalized v. Standard Care

Why do Pharma companies care about personalized medicine given that this might limit the population for which their drug is approved?

Low response rates to therapy and lack of patient benefit compared to the standard of care can put success of a clinical trial and overall drug development at risk. Therefore pharma companies are invested in diagnostic programs to:

  • select the right patients for their drug
  • minimize the risk of drug failure
  • get drugs to market faster
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Topics:  predictive test, personalized medicine, tissue phenomics, biomarkers, cancer diagnostics, companion diagnostics, tissue markers, oncology, prognostic test

Tissue Phenomics™ - Complementing Genomics for Improved Cancer Diagnostics

Jul 15, 2014 12:00:00 AM

One way to develop prognostic and predictive tests in oncology is through the use of genomic biomarkers. And as more diagnostics companies are recognizing the potential benefits of this method, we’re seeing an increase in the number of companion diagnostic tests relying on gene-based biomarkers. Another reason for this continued trend towards personalized medicine is the continually decreasing costs of whole-genome sequencing.

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