Companion Dx | DiaCarta, Inc.

Companion Diagnostics

A Range of Customizable Testing Services Powered by 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 development of such tests is clear, the progress has been slow. During 1998 and 2016, 167 cancer drugs have been approved by the U.S. FDA. However, only 10% of the treatments have companion diagnostics.

Alignment Drug and Diagnostic Development

The majority approved companion diagnostics tests focus on cancer therapy. Using the knowledge of cell signaling pathway, companion diagnostics help predict patient treatment outcomes based on a tumor’s genetic make-up. With a better understanding of the mechanism for cancer development and increased sensitivity of molecular diagnostics, development of companion diagnostics for different therapeutics drugs has drastically speeded up. The market for the global diagnostic market is estimated to reach $6.51B from $2.17B in 2016, with a Compound Annual Growth Rate (CAGR) of 20.1% according to MarketsandMarkets.

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.

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.

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