In a significant advancement for cancer diagnostics, researchers at the University of California, Los Angeles (UCLA) are developing a rapid, paper-based test to detect cancer cells in cerebrospinal fluid (CSF) on the same day a patient is seen by their doctor. This innovative approach aims to drastically reduce the diagnostic turnaround time for leptomeningeal disease (LMD), a severe complication where cancer cells invade the CSF surrounding the brain and spinal cord.
Current Diagnostic Challenges
Existing methods for detecting LMD often involve sending CSF samples to laboratories for processing, which can take one to two weeks to yield results. Furthermore, the initial tests have a detection rate of only about 50%, frequently necessitating additional testing to improve accuracy. This prolonged diagnostic period can delay the initiation of effective treatment, a critical issue given that untreated LMD survival is limited to mere weeks.
"You can’t wait a month or two to establish a diagnosis or see if treatment is working. That is critical time that we do not have," said Won Kim, MD, neurosurgical director of the brain metastasis program at UCLA Health and co-investigator of the study.
A Novel Paper-Based Test
In collaboration with Daniel Kamei, PhD, a professor of bioengineering at UCLA, Dr. Kim is working to create a point-of-care test that allows for the immediate analysis of CSF. The envisioned test kit would enable doctors to extract CSF from patients and apply it directly to a paper-based assay, similar to home pregnancy or COVID-19 tests.
"The infrastructure is there to mass produce these types of paper-based diagnostics with low cost and high shelf life," noted Kamei.
Overcoming Technical Hurdles
The development team faces key challenges, including detecting very low concentrations of cancer cells in CSF using a paper-based test and accurately determining cancer cell concentrations to monitor treatment effectiveness.
"One of the challenges is being able to detect very low concentrations of cancer cells in cerebrospinal fluid with a paper-based test," Kamei explained. "Another challenge is being able to determine concentrations of cancer cells since these types of tests generally provide only yes or no answers. Such yes or no answers are all you need to detect for COVID and pregnancy, but for this application, you need to determine if the concentration of cancer cells is decreasing with a particular treatment regimen."
NIH Funding and Future Trials
The UCLA project is supported by a two-year, $375,000 grant from the National Institutes of Health (NIH). The initial phases involve developing and testing two different assays using purchased cancer cells, followed by trials with patient samples.
"If the technologies work with cancer cells, then we’ll start testing with cerebrospinal fluid samples from patients," Kim stated. "If we’re able to validate this in our human patients for the initial testing phase, we would like to move towards a multicenter clinical trial."
