There Were 5 Precision Medicine Products in 2008. How Many There Are Now May Surprise You

There Were 5 Precision Medicine Products in 2008.  How Many There Are Now May Surprise You

Few markets grow 26 times their size. But that may have happened with the precision medicine market. The field of personalized medicine continues to make progress, delivering significant benefits to patients but also facing challenges. Kalorama's general sentiments about this market are confirmed in some sense by the March 2017 publication of a Personalized Medicine Coalition's report.


Must Have vs. Nice-to-Have: Navigating Complementary and Companion Diagnostics Tests

The companion testing market opportunity reflects far more than the original concept of companion - those required, FDA-mandated test/therapeutic pairs. The increasing role of supportive tests should be part of companion IVD product development. But there are some keys to understanding the market and launching new test products. All roads, it would seem, lead to data from clinical studies that can validate usage.


The Continual Search for Biomarkers - Cancer, Cardiovascular, Immunology, Infectious Diseases and Neurological Diseases

Biomarkers are a highly dynamic space within life science characterized by individual progression through discovery; validation; initial standardized applications in preclinical studies and clinical trials; and incorporation into clinically approved in vitro diagnostic (IVD) assays. In addition to vertical movement, individual biomarkers can be viewed in a horizontal manner across the spectrum of applicable diseases. This spectrum of biomarker usage is encompassed in Kalorama Information’s The G...


Alzheimer’s Disease Assays Target Clinical Trial Markets First

Alzheimer’s Disease Assays Target Clinical Trial Markets First

Outside of the $50+ billion clinical in vitro diagnostics (IVD) market , analytical instruments and lab diagnostics find major applications in the discovery of clinically significant biomarkers, therapeutics development, and other life sciences research activities. Entire classes of assays are originally developed to validate biomarkers as surrogate endpoints for disease, or as mechanism targets for drug development. The potential of pre-clinical assay markets is not lost to Amarantus BioScience...


Eurofins Acquisitions Highlight Leading Growth Areas in Clinical Laboratory Services Market

Eurofins Acquisitions Highlight Leading Growth Areas in Clinical Laboratory Services Market

Eurofins Scientific, a leading global provider of “bioanalytical” laboratory testing services with projected 2014 revenue of approximately $1.7 billion , recently broadened its business activities into the clinical space with two acquisitions. The laboratory group’s traditional business activities are overwhelmingly within food and feed testing (~40% of revenue); pharmaceutical and biotechnology industry testing (40%); and environmental testing (20%). Eurofins already serves as a contract resear...


Companion Diagnostics Alliances Mount - Clarient and GSK Deal Visited

Companion Diagnostics Alliances Mount - Clarient and GSK Deal Visited

In yet another sign that the ranks of recruitment are expanding in personalized medicine’s fight against cancer, GE Healthcare announced an agreement between its subsidiary Clarient Diagnostic Services and pharmaceutical giant GlaxoSmithKline (GSK). With GE Healthcare, the two entities will form a multi-purpose, data analytics- and companion diagnostics-driven network of laboratories. While operational details of the newly reached agreement have yet to be provided, certain parameters of the prog...


Recent FDA Guidance Benefits IVD Companies in Companion Diagnostics

Recent FDA Guidance Benefits IVD Companies in Companion Diagnostics

On July 31, the U.S. Food and Drug Administration (FDA) issued its finalized guidance on companion diagnostics and an oversight framework for lab-developed tests (LDTs), which have so far escaped the regulatory scrutiny visited on in vitro diagnostic (IVD) tests. The greatest impact of the FDA’s recent release will fall in companion diagnostics (also known as pharmacodiagnostics) or tests that inform clinicians of the efficacy or benefit of a pharmaceutical based on the genetics of an individual...


Profiling the Current Companion Diagnostics Landscape

Profiling the Current Companion Diagnostics Landscape

With the approval of Qiagen’s therascreen KRAS RGQ PCR Kit for use with the Amgen drug Vectibix, the number of applications for non-LDT, marketed companion diagnostics (CDx) products in the United States has reached 20. The companion in vitro diagnostics market is entering a new phase with over half of all FDA approvals in the previous four years and a burgeoning pipeline. Close collaboration has been key to recent simultaneous pharmaceutical-CDx FDA approvals, and partnerships between IVD compa...