Biocept Inc (NASDAQ:BIOC) said that a poster presentation at the annual American Society of Clinical Oncology (ASCO) demonstrates the impressive ability of the company’s cerebrospinal fluid assay CNSide to detect rates of leptomeningeal metastases, compared with standard CSF cytology from lumbar puncture.
In a nutshell, leptomeningeal metastases (LM), is a type of cancer in the cerebrospinal fluid and membranes that surround a person’s brain and spinal cord (the leptomeninges).
The poster, titled “Evaluating the diagnostic performance of leptomeningeal diagnosis with CNSide compared to standard cytology,” was presented by Dr Haley Appel at the Miami Cancer Institute, Baptist Health South Florida, on Saturday, June 3. An abstract, including a link to the full poster is accessible to ASCO registrants.
The San Diego, California-based molecular diagnostics company noted that in the largest single-institution, real-world study of CNSide, samples were analyzed from all neuro-oncology patients with suspected LM who underwent lumbar puncture from January 2020 through December 2022 using CSF cytology and the CNSide assay.
Among the 87 cases evaluated, most with primary breast or lung cancer, the authors found increased sensitivity for CNSide relative to standard CSF cytology and higher specificity relative to EANO-ESMD LM diagnostic criteria.
In addition, CNSide provided clinically relevant, cell-based molecular and cell-free DNA analyses and increased the diagnostic yield by 56.5%.
“The findings from this…study with CNSide is highly encouraging, with the authors noting that all cytology positive and equivocal cases of LM were detected by CNSide,” said Biocept Chairman and interim CEO Sam Riccitelli.
“We are delighted that new, third-party data highlighting CNSide were shared at one of the most prestigious and largest oncology conference of the year.”
Riccitelli noted that Biocept recently began patient enrollment in its FORESEE clinical trial with the goal of generating further evidence of the clinical utility of CNSide in detecting cancers that have metastasized to the central nervous system.
“The findings of this trial will be important in our efforts to expand the commercialization of this important test to detect the presence of tumor, as well as to guide and monitor therapy for these terminally ill patients,” added Riccitelli.
In March this year, Biocept enrolled the first patient in its FORESEE clinical trial with CNSide (NCT05414123). The FORESEE trial is a multicenter, prospective clinical trial expected to enroll 40 patients with breast or non-small cell lung cancer who have suspicious or confirmed LM. The goal of the trial is to evaluate the performance of CNSide in monitoring the LM's response to treatment and to assess the impact of CNSide on treatment decisions made by physicians.
Priya Kumthekar, associate professor of Neurology and Medicine at the Feinberg School of Medicine at Northwestern University, is the principal investigator.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
Follow her on Twitter: @UttaraProactive