DiaCarta offers a range of customizable testing services using XNA technology
We are committed to providing companion diagnostics development services customized for your needs. In addition, we offer unique project management services to ensure your project is completed in a timely manner and ready for regulatory submission.
We provide customized molecular tests on FFPE samples, liquid biopsy samples such as blood, and challenging small biopsies and cytology samples (fine needle aspirates, effusions, and CSF).
What is Companion Diagnostics and Why it is Important?
For patients with the same disease, the treatment results using the same therapeutic drug can be very different due to disease heterogeneity. Such heterogeneity can include, but not limited to, different driver mutations in oncogenes for cancer patients. Because of the protein functional changes resulting from their corresponding gene mutations, the therapeutic drugs targeting these proteins may not work anymore (resistance to the drug). It is necessary to screen the patients for these particular cancer gene mutations so different therapeutic drugs can be used to target cancer patients with different gene mutations.
This is the application for companion diagnostics. Companion diagnostics use predictive biomarkers to identify the most appropriate cancer patients and thus enhance treatment outcomes.
Companion Diagnostics Development Steps
Although the concept of companion diagnostics has been around for 40 years and the steps for
Alignment Drug and Diagnostic Development
The majority approved companion diagnostics tests focus on cancer therapy. Using the knowledge of cell
The Challenge of Companion Diagnostics
One key challenge for developing effective companion diagnostics is to coordinate the drug development and companion diagnostics development so they can be aligned from both product and regulatory point of view.
Activating Mutations and Targeted Cancer Therapies
We are committed to providing companion diagnostic development services customized for your needs. In addition, we offer unique project management services to ensure your project is completed in a timely manner and ready for regulatory submission.
Currently, targeted therapies attack the following targets
Targeted Therapy for the EGFR Gene as an Example for Companion Diagnostics
One of the examples for companion diagnostics for lung cancer treatment is targeted EGFR therapy. Among the metastatic Non-Small Cell Lung Cancer (NSCLC) patients, about 30 to 50 % of Asian and 7 to 23% Western of them have EGFR activating mutations such as exon 19 deletion or L858R. These patients are highly responsive to EGFR inhibitors, such as gefitinib and erlotinib. There is strong clinical evidence to support that these EGFR inhibitors only work with the patients with above activating EGFR mutants. However, almost 63% of the patients develop resistance after 8 to 14 months of drug treatment due to development of a new mutation in EGFR, T790M. Correct and in-time identification of EGFR mutations using companion diagnostics is critical for the development of effective patient therapy strategies.