Clinical Trial to Test Biocept’s Target Selector Platform as Diagnosis, Monitoring Tool for Lung Cancer

Clinical Trial to Test Biocept’s Target Selector Platform as Diagnosis, Monitoring Tool for Lung Cancer

Biocept and the Addario Lung Cancer Medical Institute (ALCMI) will collaborate on a clinical study assessing the efficacy of Biocept’s Target Selector platform to detect circulating biomarkers in patients with lung cancer.

ALCMI, based in San Carlos, California, is an international research consortium of 21 U.S., British, Spanish, French and Italian oncology centers that aims to shorten the bridge between research and cancer patients.

The Target Selector platform detects the presence of cancer biomarkers in circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in patients’ blood samples. If proven successful, this tool will soon help doctors diagnose lung cancer using liquid samples instead of tissue biopsies, which are harder to obtain and more expensive to analyze.

“We are pleased to join forces with major research institutions and cutting-edge molecular diagnostics companies such as Biocept to conduct a large-scale trial evaluating the use of liquid biopsy to detect and monitor key lung cancer biomarkers,” Steven Young, ALCMI’s president and chief operating officer, said in a press release.

The prospective ALCMI-009 trial will enroll 400 patients with advanced non-small cell lung cancer (NSCLC). From the group, four to six blood samples will be collected over a period of one year. Researchers will then use the Target Selector platform to investigate the presence of cancer biomarkers in the blood, such as EGFR, BRAF, KRAS, ALK fusions, ROS1 fusions and PD-L1 expression.

Researchers will also assess CTC counts and ctDNA mutations to follow patients’ drug response, predict treatment failure and identify molecular mechanisms that may resist treatment. Participants will be divided into groups based on their cancer subtype and disease stage — for instance advanced NSCLC patients with squamous cell and non-squamous cell carcinoma, early-stage NSCLC (stages I-III) or small cell lung cancer (SCLC).

“We have targeted several highly important objectives for this trial that could have a profound impact on the treatment of patients with lung cancer,” said Dr. Luiz Raez, one of the trial’s principal investigators. “Validating the concordance of liquid biopsy and tissue biopsy across the dozens of ALCMI member institutions could open new opportunities for using this approach when tissue biopsy material is exhausted or difficult to obtain.”

Added Biocept President and CEO Michael Nall: “The results of this large-scale study with renowned oncology centers could further validate the extremely high sensitivity and specificity that we have demonstrated with our Target Selector platform in past studies. We are excited to work with ALCMI on this groundbreaking clinical trial.”

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