Real-world retrospective study showed increased sensitivity for CNSide relative to standard cerebral spinal fluid (CSF) cytology in detecting leptomeningeal metastases

Biocept, Inc. (NASDAQ: BIOC) (“Biocept” or the “Company”), a leading provider of molecular diagnostic assays, products and service, announces a poster presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting underway in Chicago showing the ability of CNSide™ to detect rates of leptomeningeal metastases (LM) compared with standard CSF cytology from lumbar puncture. 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. The abstract of the poster is available here, including a link to the full poster which is accessible to ASCO registrants.

In the largest retrospective, 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. Further, CNSide provided clinically relevant, cell-based molecular and cell-free DNA analyses and increased the diagnostic yield by 56.5%.

“The findings from this largest-ever, retrospective study with CNSide are highly encouraging, with the authors noting that all cytology positive and equivocal cases of LM were detected by CNSide. 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,” said Sam Riccitelli, Chairman and interim President and CEO of Biocept.

“We recently began patient enrollment in our 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,” he added. “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.”

About the FORESEE Clinical Trial

In March 2023 Biocept announced enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay 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, MD, Associate Professor of Neurology and Medicine (hematology and oncology) at the Feinberg School of Medicine at Northwestern University, is Principal Investigator.

Standard-of-care methods to diagnose or assess the treatment response of LM (i.e., clinical evaluation, MRI and cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. CNSide is a Laboratory Developed Test (LDT) that is used commercially at the physician's discretion, with samples processed in Biocept's CLIA-certified, CAP-accredited laboratory.

About CNSide

Using our proprietary CNSide assay to analyze and interrogate CSF-TCs and cfDNA for certain biomarkers, physicians can be better informed about the actionable molecular information associated with a patient’s metastatic cancer and develop a personalized cancer treatment plan. Through CNSide, Biocept’s test menu focuses on cancer biomarkers that are clinically actionable based on clinical treatment guidelines listed by the National Comprehensive Cancer Network® (NCCN®). For more information, please visit https://biocept.com/technology/.

About Biocept

Biocept is a molecular diagnostics company with commercialized assays for patients with carcinomas or melanomas. Our experts have spent years working to change the way physicians look at cerebrospinal fluid in cancer patients. Biocept has developed a unique, patented methodology to isolate cancer material that is shed from the primary tumor, such as CSF tumor cells (CSF-TCs) and cell-free DNA (cfDNA). As such, Biocept is a leading commercial provider of testing services designed to enable clinicians to rapidly detect and monitor cancer biomarkers from a cerebrospinal fluid sample.

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