COMPANY:

Biocept

"Biocept...announces enrollment of the first patient in the FORESEE clinical trial with the Company’s proprietary cerebrospinal fluid assay CNSide (NCT05414123). This first patient was seen at the UT Southwestern Medical Center, one of the largest and most respected hospitals in the nation."

"Biocept...announces a collaboration agreement to participate in an investigator-initiated, non-therapeutic pilot study to evaluate the cerebrospinal fluid tumor and immune cell microenvironment in patients with metastatic breast cancer and brain metastases and/or leptomeningeal disease. The study is designed to identify biomarkers associated with central nervous system (CNS) metastasis, enabling a better understanding of treatment response, prognosis, and treatment resistance that may improve the management of CNS disease in patients with metastatic breast cancer...Results from cerebrospinal fluid using Biocept’s CNSide assay and matched patient blood samples will be analyzed and compared to detect and characterize cancer in the cerebrospinal fluid with the goal of identifying new targets and to guide therapeutic decisions."

"Biocept, Inc...announces the expanded commercial availability of CNSide for patients with metastatic melanoma. Previously validated for lung, breast, and all other carcinomas, Biocept’s CNSide is a proprietary CSF assay designed to better detect and inform treatment decisions for patients with metastatic cancers involving the central nervous system (CNS)...The new CNSide for melanoma assay uses a novel antibody cocktail optimized for the capture of melanoma cells based on unique cellular characteristics."

"Biocept, Inc...announces an hour-long webinar to be held October 14 at 1 p.m. Eastern time featuring case studies presented by leading neuro-oncologists who have used the company’s CNSide assay in the management of patients with confirmed or suspected central nervous system metastasis."

"Plus Therapeutics, Inc...and Biocept, Inc...announce a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord."

"Biocept, Inc...highlighted the ability of its CNSide™ cerebrospinal fluid (CSF) assay to aid in therapeutic research programs for metastatic brain cancer in a presentation at the Molecular & Precision Med Tri-Con meeting. The company is also exhibiting (booth #508) at the conference, which is the leading international meeting for the precision medicine community, Feb. 21-23, 2022, in San Diego."

"Biocept, Inc...presented a study demonstrating the ability of its CNSide™ assay to identify HER2 and other actionable tumor alterations in the cerebrospinal fluid of patients with breast cancer and leptomeningeal disease (LMD). The poster was chosen for a Spotlight Presentation at the San Antonio Breast Cancer Symposium on Dec. 8, 2021."

"Physicians in the United States can now order the liquid biopsy-based Target Selector™ NGS Lung Panel test directly from Quest Diagnostics...Developed by Biocept, Inc...the lab-developed liquid biopsy test aids genomic profiling in patients with advanced non-small cell lung cancer (NSCLC), helping physicians identify potential targeted therapies and monitor the effectiveness of treatment...The Target Selector NGS Lung Panel contributes to better patient outcomes by providing physicians with direction on therapeutic options for those battling NSCLC."

"Biocept...announced the presentation of a multi-institutional case series showing that its CNSide™ cerebrospinal fluid assay helps physicians monitor treatment response and detects actionable mutations in patients with metastatic breast cancer and leptomeningeal disease (LMD). The poster will be presented virtually at the Society for Neuro-Oncology Annual Meeting...At diagnosis, CNSide detected cancer cells in three of three patients, compared with two of three patients for cytology. (The fourth patient was diagnosed before CNSide was available.) CNSide detected CSF tumor cells in all eleven measurements taken, compared to six of eleven using cytology. Throughout treatment, CNSide showed a decrease in CSF tumor cells in all four patients, ranging from 99.7% to 100%, corresponding with an improved clinical response."

"Biocept, Inc...today announced the publication of a study showing that the addition of Switch-Blocker™ technology to common PCR-based liquid biopsy assays significantly increased sensitivity in detecting rare cancer mutations...Results showed that the addition of Switch-Blockers increased the sensitivity of allele-specific primer assays by more than 200 times, from about 1% minor allele frequency (MAF) to better than 0.01%. The sensitivity of multiplex competitive allele-specific TaqMan assays, commonly used with PCR amplification, were increased greater than 1,000 times, from about 10% MAF to 0.01% or better. The ability to significantly increase the sensitivity of conventional mutation assays using Switch-Blocker technology is critical for helping to find rare genetic events in a wide range of applications, including solid tumor cancers, where a majority of biomarkers in blood occur at less than 1% MAF."

"Biocept (Nasdaq: BIOC)...will present data on its Target Selector™ assay formats for the ultra-sensitive detection of KRAS mutations using Switch-Blocker™ technology, which provides advantages for the assessment of therapeutic tumor response and is cost effective for serial monitoring. Biocept’s presentation is on Sept. 23 at 2:00 p.m. EDT at the Third Annual RAS-Targeted Drug Development Summit...The presentation, titled 'The Ultra-Sensitive Detection of KRAS Mutations Using Switch-Blocker™ to Aid Therapeutic Decisions and Monitoring'..."

"Biocept...today announced that new data show the company’s cerebrospinal fluid assay, CNSide™, detected tumor cells and identified actionable mutations in lung cancer patients with leptomeningeal carcinomatosis, allowing for targeted treatment decisions that may improve outcomes and extend life expectancy. The study will be presented as a poster at the Third Annual Conference on Brain Metastases hosted by the Society for Neuro-Oncology (SNO), being held virtually Aug. 19-20, 2021."

"Biocept, Inc...has received a positive final Local Coverage Determination (LCD) that expands Medicare coverage for use of its Target Selector assay to identify the HER2 biomarker from circulating tumor cells (CTCs). This coverage determination from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDx) was effective July 4, 2021."

"Biocept, Inc...has been awarded a South Korean Patent for its Primer-Switch technology, which detects rare mutations in circulating tumor DNA (ctDNA) using real-time PCR and associated analysis methods. The patent (No. 2252447) is titled Methods for Detecting Nucleic Acid Sequence Variants...This is the fourth issued patent for the technology, which identifies rare cancer biomarkers found in tissue, blood, and cerebrospinal fluid (CSF). Primer-Switch provides a unique method for specifically enriching patient specimens for mutations of interest. It can be used to enhance the performance and specificity of the PCR method, the most widely used amplification approach for research and clinical diagnostic applications. It also enables the interrogation of fragmented DNA that is often found in biological fluids."

"Biocept, Inc...today announced a collaboration with Quest Diagnostics...to provide laboratory testing services to Quest patients for its Target Selector™ NGS-based liquid biopsy targeted lung cancer panel. Quest Diagnostics is the leading provider of diagnostic information services, including in advanced diagnostics...The two parties expect the service to be available to Quest Diagnostics’ providers and patients in the fourth quarter of 2021."

"Biocept, Inc...has announced the full commercial launch of CNSide™, its cerebrospinal fluid (CSF) assay designed to better detect and manage treatment of metastatic cancers involving the central nervous system (CNS). The assay, initially introduced in January 2020, has the ability to offer a timely and accurate method to diagnose disease, identify actionable biomarkers, and assess response to therapy, potentially impacting life expectancy and quality of life."

"Biocept, Inc…will collaborate with Protean BioDiagnostics Inc. to research the ability of Biocept’s Target Selector™ molecular assay to determine EGFR status in non-small cell lung cancer (NSCLC) patients. The research will be conducted in an independent pathology laboratory setting...Protean BioDiagnostics also expects to validate the analytical performance of a laboratory developed test (LDT) based on Biocept’s EGFR assay test kit in accordance with the requirements of the College of American Pathologists (CAP) validation process....'We are pleased to collaborate with Biocept to demonstrate the potential of its assay in determining EGFR status,' said Anthony M. Magliocco..."

"Biocept, Inc...will present data showing that its Target Selector™ molecular assay kit detects mutations in up to 50% of tissue biopsy specimens, from patients diagnosed with non-small cell lung cancer, that were deemed quantity not sufficient (QNS). The study will be presented at the Molecular Med Tri-Con Virtual Conference, Feb. 16-18, 2021...The pilot study utilized Biocept’s Target Selector molecular assay with Switch-Blocker technology, which offers ultra-high sensitivity and requires less tumor sample than most commercial assays. The assay was used to evaluate the presence of several key EGFR and KRAS mutations in formalin-fixed paraformaldehyde embedded (FFPE) tissue slides, supplied by NeoGenomics Laboratories, Inc. that were deemed QNS for next generation sequencing (NGS) analysis. Results showed that EGFR mutations were detected in 50% (3/6) of patient samples, and KRAS mutations in 17% (1/6) of samples."

"Biocept, Inc…announces that it has entered into laboratory services agreements with independent physician associations (IPAs) providing physicians and patients in-network access to Biocept's full array of Target Selector™ liquid biopsy oncology assays and services. Both IPAs are headquartered in San Diego and combined serve more than 70,000 covered lives in the Southern California region."