Scientific Poster Presented at the 2023 ASCO Annual Meeting Highlights Performance of Biocept’s CNSide™ Versus Cytology
June 05 2023 - 8:00AM
Business Wire
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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Investor and Media Contact: Jody Cain, LHA Investor
Relations Jcain@lhai.com, 310-691-7100
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