Cancer Genetics Incorporated announced today that its immuno-oncology (IO) assay, Complete::IO, received Clinical Laboratory Improvement Amendments (CLIA) validation and approval. This new screening tool is intended to provide a fast and accurate determination of the immune repertoire of cancer patients, helping doctors assess which patients are responding to immunotherapy treatment.
Development of new therapies that modulate the immune system response has become the main approach in the battle against cancer. Improved knowledge and more targeted therapies have allowed researchers and physicians to find ways to tackle a wide range of cancers.
Since IO drugs become first-line of treatment for many cancers, there is a clear need of tools that can monitor the immune system’s response. Based on flow cytometry methodology, Complete::IO is a multi-marker panel that simultaneously detects of up to 10 markers on each cell. This overcomes some of the limitations that current standard technologies have, allowing the identification of rare and challenging subsets of immune cells that are in circulation or within the tumor microenvironment.
“With the extremely high promise of IO therapies and CGI’s track record in innovative and proprietary assay development and application, we believe that Complete::IO will become a key tool in selecting patients, monitoring response, and predicting toxicities in IO therapies,” Daniel Duncan, MD, medical director at CGI, said in a press release.
Complete::IO has the potential to help monitoring changes, responses, and potential toxicities during clinical trials and in routine patient care, improving the assessment of anti-tumor immune response and the development of personalized immunotherapy treatment protocols.
“Complete::IO is already being utilized in the clinical setting for both hematologic malignancies and solid tumors, and is being implemented by our biopharma partners for clinical trials in such indications as glioblastoma,” said Duncan.
Built on the company’s previous experience, Complete::IO panel was designed to address the needs of various cancer indications, with optimized cell marker combinations to minimize cost and unwanted technical bias. The technical workflow was developed to retrieve the information within a 24-hour period.
“Complete::IO can become an integral component of immuno-oncology patient monitoring for cancer centers and hospitals nationally. Additionally it can be a valuable tool for patient selection and stratification, as well as monitoring therapy effectiveness for our biopharma customers,” said Panna Sharma, CEO and president of CGI. “We fully expect to continue developing the panel as it uniquely offers complex and comprehensive assessment of the patient immune response within one day of receiving the sample.”
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