Biocept, in collaboration with Columbia University Medical Center, plans to conduct a clinical study to assess its Target Selector platform’s ability to diagnose leptomeningeal metastases (LM) in women with breast cancer.
The study’s main objective is to determine whether the platform can detect cancer cells in CSF (cerebrospinal fluid) samples and diagnose LM with better sensitivity than standard techniques, such as MRI.
LM is a condition that develops when breast cancer cells enter the CSF — the fluid in the brain and spine — and travel to those body parts. Once there, the cells can develop into metastases and considerably complicate a patient’s condition.
Biocept’s Target Selector platform is designed to detect biomarkers of tumor cells originating from breast cancer in CSF samples. If proven effective, it could help doctors diagnose brain metastases in women with breast cancer and initiate treatment.
“Diagnosing LM in patients with breast cancer can be challenging, given the low diagnostic sensitivity of traditional methods such as cytologic analysis,” Kevin Kalinsky, MD and the study’s senior researcher, said in a news release. “We will be using Biocept’s Target Selector technology to evaluate oncologic biomarkers in the CSF of breast cancer patients, with the potential to provide a rapid and accurate solution to confirm diagnosis and enable patients to begin treatment for LM earlier. This clinical study addresses a significant medical need, given the devastating nature of LM involvement in breast cancer patients.”
Researchers expect to enroll 46 breast cancer patients in the study and perform lumbar punctures to look for leptomeningeal metastases in the CSF.
The study has several secondary objectives, including using the platform to compare the detection of cancer cells in CSF and in blood samples from the patients, and assessing its usefulness in determining levels of estrogen, progesterone, and the HER2 receptor in CSF samples (all are associated with breast cancer growth).
“We are very pleased to again collaborate with Dr. Kalinsky and Columbia University Medical Center in this study designed to further validate the clinical utility of our Target Selector platform in order to improve the diagnosis and treatment of LM,” said Michael Nall, Biocept’s president and CEO.
The release did not mention when the study might begin.