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Diagnostics Oncology Product Launch

 News Release - November 21, 2019

Biocept Announces the Launch of its Liquid Biopsy Test to Detect TRK Biomarkers in the Blood of Patients Diagnosed with Cancer

Biocept's patented Target Selector™ test for identification of TRK proteins enables physicians to rapidly and cost-effectively identify the potential presence of NTRK fusions used to inform on treatment options

SAN DIEGO, Nov. 21, 2019 -- (Healthcare Sales & Marketing Network) -- Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the commercial availability of its Target Selector™ pan-TRK assay for the detection of TRK proteins. With the Biocept assay, a simple blood sample can help inform physicians on the potential presence of NTRK fusions, which are actionable biomarkers that can be used to qualify patients for treatment with TRK inhibitor therapies. With the launch of this new assay, Biocept now offers 20 CLIA-certified liquid biopsy tests utilizing its Target Selector™ platform to determine the status of actionable solid tumor biomarkers.

"Biocept's Target Selector pan-TRK assay utilizes our proprietary circulating tumor cell (CTC) platform, which enables a simple blood-based test to screen for TRK gene alternations, a unique liquid biopsy offering," said Veena Singh, MD, Senior Vice President and Senior Medical Director at Biocept. "Biocept's novel liquid biopsy tests are designed to help physicians rapidly and in real-time identify key biomarkers of interest to facilitate the clinical decision making process."

"We continue to execute on expanding our menu of non-invasive and cost-effective biomarker tests," said Biocept's President and Chief Executive Officer Michael Nall. "Biocept now offers 20 commercially available liquid biopsy assays including two tumor-specific next generation sequencing panels that cover the most actionable genomic alterations for solid tumors. We believe that this comprehensive offering, including the addition of our Target Selector™ pan-TRK test, will help us increase adoption of our liquid biopsy platform in the oncology market."

About Biocept's Liquid Biopsy pan-TRK Test for Potential NTRK Fusions

Precision medicine in oncology continues to evolve as the number of clinically validated biomarkers to determine treatment pathways for specific tumor types is growing. Genomic profiling has identified fusions of the NTRK gene, involving either NTRK1, NTRK2 or NTRK3, which encode for the protein receptors TRKA, TRKB and TRKC, respectively1. The presence of TRK proteins has been associated with more aggressive cancer in certain tumor types, such as lung cancer2. Currently, for qualified patients with NTRK fusions, there are two approved first-generation TRK inhibitor therapies on the market, Vitrakvi® (larotrectinib) and Rozlytrek® (entrectinib), which are associated with high clinical response rates (>75%)3. While the prevalence of NTRK fusions is low, they can be found across a broad range of tumor types, therefore testing patients for this family of biomarkers may be warranted4. Biocept's novel Target Selector™ pan-TRK assay is a liquid biopsy test designed to detect NTRK antibodies from a patient's blood sample. Sensitivity and specificity between the presence of TRK proteins and FISH detection of NTRK fusions is 95.2% and 100%5, respectively, therefore, Biocept's pan-TRK assay can be used as a simple and cost-effective method for determining the potential presence of NTRK fusions and whether further testing is advised. For more information about Biocept's Target Selector™ testing, please contact Biocept Customer Services at 888.332.7729.

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both CTCs and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the outcomes of patients diagnosed with cancer, the potential clinical utility of our proprietary technology platform and our ability to increase adoption of our liquid biopsy platform in the oncology market, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

References:
  1. A. Drilon, et al. Efficacy of Larotrectinib in TRK Fusion-Positive Cancers in Adults and Children. N Engl J Med. 378:731-739, 2018.
  2. A. Lange, et al. Inhibiting TRK Proteins in Clinical Cancer Therapy. Cancers (Basel) 2018 Apr; 10(4): 105.
  3. E. Coco, et al. NTRK Fusion-Positive Cancers and TRK Inhibitor Therapy. Nat Rev Clin Oncol 15: 737-747, 2018.
  4. Matthew Stenger, Larotrectinib for Solid Tumors With NTRK Gene Fusions. The ASCO Post. Dec, 2018.
  5. J. Hechtman, et al. Pan-Trk Immunohistochemistry is an Efficient and Reliable Screen for the Detection of NTRK Fusions. Am J Surg Pathol. 2017 Nov; 41(11): 1547–1551.


Source: Biocept

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