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Biocept, Inc. (symbol: BIOC) is a leading molecular oncology diagnostics company, specializing in the analysis of circulating tumor-associated DNA. The company focuses on both circulating tumor cells (CTCs) and cell-free circulating tumor DNA (ctDNA) in plasma. Biocept’s mission is to enhance cancer patient outcomes through the advancement of oncology diagnostics.
Utilizing patented and innovative technologies, Biocept delivers clinically relevant prognostic and predictive assessments to physicians, aiding in the treatment course for cancer patients. Their key offering, the Target Selector™ technology, is renowned for its ability to consistently capture extremely rare cells, which may be found in as few as 1 in 50-100 billion blood cells. This technology allows for precise biomarker analysis, assisting in better disease management and treatment decisions.
Beyond direct patient services, Biocept extends its expertise to other laboratory testing providers, academic institutions, research organizations, and biopharmaceutical companies. They play a vital role in clinical trial support, contributing to the development of new cancer therapies.
Biocept’s recent achievements highlight their commitment to innovation and excellence in oncology diagnostics. The company continually strives to expand its technological capabilities and partnerships, ensuring the delivery of high-quality diagnostics solutions to the oncology community.
Biocept, Inc. (NASDAQ: BIOC) reported a significant increase in COVID-19 RT-PCR testing volume in 2022, attributed to the Omicron variant. Since 2022, the company has processed over 40,000 samples, adding to more than 765,000 since June 2020. Biocept's testing is noted for its high sensitivity and accuracy, detecting multiple gene targets. Demand has surged primarily from skilled nursing facilities, though community college demand has decreased due to vaccination mandates. Biocept has renewed its contract with the Foundation for California Community Colleges, extending through 2022.
Biocept, Inc. (NASDAQ: BIOC) will present at the H.C. Wainwright BioConnect Virtual Conference from January 10-13, 2022. CEO Michael Nall emphasized the company's focus on generating clinical data to support the adoption of CNSide™, a cerebrospinal fluid assay for diagnosing metastatic brain cancer. This assay addresses significant clinical needs in cancer diagnosis. Additionally, Biocept continues its COVID-19 testing efforts, which help fund its long-term oncology strategy. The presentation will be accessible on the Investor Relations section of the Biocept website starting January 10, 2022, at 7:00 AM ET.
Biocept, Inc. (NASDAQ: BIOC) presented a study on December 8, 2021, at the San Antonio Breast Cancer Symposium, demonstrating the effectiveness of its CNSide™ assay in identifying HER2 and actionable tumor alterations in cerebrospinal fluid (CSF) from patients with breast cancer and leptomeningeal disease (LMD). The study revealed that 56% of patients exhibited HER2 amplification, while 38% had differing HER2 status between primary tumors and LMD. The CNSide assay aims to improve treatment decisions for patients suffering from LMD, potentially enhancing survival and quality of life.
Aegea Biotechnologies has announced the validation of its PCR-based COVID-19 assay by Biocept, Inc. This test is notable for its high sensitivity and specificity, capable of quantifying SARS-CoV-2 viral load, essential for assessing infection levels and contagiousness. The assay demonstrated a 100% detection rate in clinical validation and sensitivity for single RNA copies, making it a potentially superior option compared to existing tests. Aegea is engaging with the FDA regarding regulatory paths for the assay.
Biocept (NASDAQ: BIOC) has expanded its COVID-19 testing services to include a new assay that simultaneously detects and differentiates between SARS-CoV-2 and influenza. This initiative, which began in June 2020, has processed over 670,000 samples. The new test provides timely results within approximately 48 hours and aims to enhance treatment decisions and public health initiatives. However, the commercialization of the co-developed AEGEA Biotechnologies COVID-19 assay will face delays due to new FDA requirements for laboratory-developed tests.
Biocept, Inc. (Nasdaq: BIOC) announced a presentation at the Society for Neuro-Oncology Annual Meeting on Nov. 19, 2021, showcasing a case series that validates the effectiveness of its CNSide™ assay for monitoring treatment in metastatic breast cancer patients with leptomeningeal disease (LMD). This assay outperformed traditional cytology in detecting tumor cells, revealing a significant decrease in cancer cell counts, indicating positive treatment responses. The study included four patients across multiple institutions, enhancing confidence in treatment decisions.
Biocept, Inc. (Nasdaq: BIOC) reported significant growth for Q3 2021, with revenues of $17.5 million, a 165% increase from the previous year, primarily driven by RT-PCR COVID-19 testing. The company achieved profitability with a cash balance of $27.7 million as of September 30, 2021. CNSide™, Biocept's neuro-oncology test, saw robust volume growth and expanded customer base. Additionally, Biocept received positive Medicare coverage for the Target Selector breast cancer assay, reinforcing its position in oncology diagnostics.
Biocept has released a study revealing a significant increase in assay sensitivity through its innovative Switch-Blocker technology. The research published in the Journal of Molecular Diagnostics indicates that this technology can enhance sensitivity by over 200 to 1,000 times for detecting rare cancer mutations in blood samples. This advancement is crucial for accurately identifying oncogenic mutations, thus improving cancer treatment monitoring and selection. The Switch-Blocker platform is validated for clinical applications with strong implications for early disease detection and therapeutic assessment.
Biocept, a provider of molecular diagnostic assays, will release its financial results for the three and nine months ended September 30, 2021, on November 15, 2021, after market close. An investor conference call will follow at 4:30 p.m. ET to discuss the results. Biocept specializes in molecular diagnostics for cancer treatment and monitoring, including a unique cerebrospinal fluid assay, CNSide™, for detecting metastasized cancer. The company also offers COVID-19 RT-PCR testing to support public health efforts.
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