NEW YORK (GenomeWeb) – Biocept said today that it has partnered with the Addario Lung Cancer Medical Institute (ALCMI) to evaluate the use of the company's Target Selector liquid biopsy platform in a clinical study of lung cancer patients.
The Target Selector technology is designed to analyze both circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) biomarkers from a blood sample. Under the terms of the deal, ALCMI and collaborating institutions will send samples from up to 400 lung cancer patients to Biocept, which will use the platform to detect and assess key biomarkers with the goal of demonstrating the concordance of liquid biopsy to solid tissue biopsies at de novo presentation.
This concordance will validate the use of a liquid biopsy sample when biopsy tissue is depleted or difficult to obtain for biomarker stratification, Biocept said. The trial also aims to validate the utility of monitoring key biomarkers in lung cancer patients with a liquid biopsy, enumerating CTC counts, and quantifying ctDNA mutations in order to illustrate drug response, predict treatment failure prior to progression observed with radiographic imaging, and identify resistance mutations.
The company said that the trial will distinguish between advanced non-small cell lung cancer (NSCLC) patients with squamous cell and non-squamous cell carcinoma, and will evaluate the clinical utility of liquid biopsy in additional patients with early-stage NSCLC and small cell lung cancer.
Patients will have four to six blood samples drawn over a 12-month period, yielding between 1,600 and 2,400 liquid biopsy data points. Data from the study are expected to be centralized in a large-scale database that will include uniform and complete patient demographic, pathology, and clinical information.
"We have targeted several highly important objectives for this trial that could have a profound impact on the treatment of patients with lung cancer," Florida International University's Luis Raez, a principal investigator for the study, said in a statement. "A better understanding of the role of serial blood-based molecular markers in making treatment decisions for lung cancer patients is critical, and may also lead to the development of novel targeted therapies."
The deal with ALCMI is the latest in a series of collaborations Biocept has formed for the Target Selector platform, ncluding partnerships with Columbia University Medical Center, the University of Minnesota, and Catalyst Pharmaceuticals.