Companion Diagnostics (CDx) Development Services

With a combination of scientific and technological excellence and a committed and passionate multifunctional team, Creative Biolabs is in a leading position to develop and commercialize in vitro diagnostic (IVD) tests. As a trusted partner to pharmaceutical companies, we offer IHC-based companion diagnostics (CDx) development services to help advance their efforts to bring the most effective personalized cancer therapies to global markets.

Introduction of CDx

A CDx assay, according to the US-America Food and Drug Administration (FDA) guidance, is defined as an IVD device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. It is required when drug/biologic has a specific genetic or biological target not present in all patients with a particular disease. Therefore, the test can be used to identify patients most likely to respond to therapeutic drug or biologic, as well as patients at lower or higher risk for a particular side effect. The technical methods for CDx tests may encompass PCR, RT-PCR, expression arrays, next-generation sequencing (NSG), fluorescent in situ hybridization (FISH), mass spectroscopy, Immunohistochemistry (IHC), and others. The need for CDx has been growing in the past decades, along with the number of potential targeted therapies.

Drug and diagnostic co-development pathway and patent filings. Fig.1 Drug and diagnostic co-development pathway and patent filings. (Zhang, C. H., 2013)

CDx Based on IHC

IHC has primarily been employed to provide a broad range of “special stains”, that mostly are used for identification and classification of cells and tumors in formalin fixed paraffin embedded (FFPE) tissues. As IHC demonstrates both the presence and cellular localization of a protein target, it is theoretically an ideal method upon which to base a CDx. When IHC is used as the basic technology for a CDx, there is an implied transition from a stain to an assay, with elements of quantification. Consequently, the question is no longer one of whether the target protein is present ( a positive “stain”), but rather it is a question of how much the target protein (or analyte) is present, requiring quantitative assessment. Any changes in the parameters and conditions, e.g. reagents, protocol, scoring, of an IHC-CDx can affect its clinical sensitivity, leading to changes in test results.

CDx Development Services Provided by Creative Biolabs

Creative Biolabs offers CDx development services based on IHC method to detect protein-based biomarkers. We are uniquely placed to partner with clients throughout the entire process of CDx development - from the fundamental research and discovery phase, through the conduct of clinical trials and the manufacturing of test kits, to the patient sample testing. We offer services including but not limited to:

  • Biomarker assay development
  • Analytical validation
  • Clinical validation
  • Kit development
  • Regulatory support/submissions
  • cGMP manufacturing
  • Project management
  • Commercialization

We focus on a wide spectrum of protein-based biomarkers that identify or track disease presence and progression, covering a variety of multiple disease areas:

  • Allergy
  • Autoimmune diseases
  • Cancer/tumor
  • Infectious diseases
  • Neurodegenerative diseases
  • Metabolic diseases

The CDx development services can be provided for pharmaceuticals in both preclinical and clinical development, as well as for pharmaceuticals that are already on the market. We offer our customers individual diagnostic solutions to implement the concept of personalized medicine. Contact us to discuss your project and experience the great value of our services.

Reference

  1. Zhang, C. H., (2013). “Maximizing the commercial value of personalized therapeutics and companion diagnostics.” Nature biotechnology, 31(9), 803.


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