Biocept Announces Commercial Launch of Target Selector™ NGS Breast Panel, the Company's Second Multi-Gene Tumor-Specific Panel

SAN DIEGO, June 18, 2019 /PRNewswire/ -- 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 launch of its Target Selector™ NGS Breast Panel, the Company's multi-gene liquid biopsy panel specifically developed for breast cancer. The panel runs on Thermo Fisher Scientific's Ion Torrent™ next generation sequencing (NGS) platform and will be marketed to physicians and researchers for the detection and monitoring of actionable genomic biomarkers associated with breast cancer.

The Target Selector™ NGS Breast Panel combines Biocept's laboratory and commercial infrastructure, as well as the Company's expertise in blood sample preservation and DNA/RNA isolation, with Thermo Fisher's industry-leading NGS panel and informatics technology, branded as Oncomine™.  Biocept believes that this offering also has potential to further enrich the content supporting Biocept's collaboration with artificial intelligence solutions provider Prognos Health, Inc.

Breast cancer is the most commonly diagnosed cancer in women and the second leading cause of cancer death among women¹. It is estimated that each year over 250,000 women in the United States will be diagnosed and more than 40,000 will die from the disease¹. Molecular profiling is used to determine the status of actionable biomarkers such as ER, PR and HER2 to guide clinicians in their treatment selection for women with breast cancer. These key targets help doctors understand which therapies may have the best chance of success and can also be used to help breast cancer patients qualify for clinical trials.

Published guidelines from the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) outline standards for determining biomarker status in patients diagnosed with breast cancer^2-5. Excision biopsies to retest initial negative results are included in clinical practice recommendations.⁵ These guidelines help to ensure that patients with breast cancer have an opportunity to qualify for potentially effective targeted therapies. However, for many breast cancer patients a metastatic biopsy may be difficult or impossible to obtain due to the physical location of a distal lesion, such as the bone, lung, brain or other hard to biopsy site. Biocept's innovative liquid biopsy solutions allow clinicians to evaluate or monitor biomarker status in patients with metastatic breast cancer utilizing its 12-gene Target Selector™ NGS Breast Panel, or its Target Selector™ single biomarker tests based on the Company's proprietary circulating tumor DNA (ctDNA) or recently expanded circulating tumor cell (CTC) detection platforms.

"We are extremely pleased to launch our second multi-gene liquid biopsy panel, this one tailored to breast cancer, which expands our Target Selector family of offerings to physicians and researchers in both academic centers and the pharmaceutical industry," said Michael Nall, Biocept's President and Chief Executive Officer. "This additional offering provides a unique liquid biopsy platform interrogating both CTCs and ctDNA in patients with breast cancer. We believe this dual approach enhances the identification of actionable genomic alterations to provide personalized treatment options.

"The multi-gene panel has undergone robust and extensive analytical and clinical validation to identify all main classes of genomic aberrations encountered in breast cancer, with an overall clinical accuracy of 99.8%, specificity of greater than 99% and sensitivity of greater than 90%," he added.  "Biocept remains the only commercial liquid biopsy company that can offer customers the flexibility to order either customized single biomarker assays or a larger NGS-based liquid biopsy test panel for use when more comprehensive testing is desired."

About Biocept's Target Selector™ NGS Breast Panel

Biocept's multi-gene tumor-specific NGS-based liquid biopsy panels allow physicians and researchers to use a simple blood sample to analyze actionable biomarkers associated with specific solid tumor types. The biomarkers included in the Target Selector™ NGS Breast Panel are those physicians frequently rely upon when making treatment decisions for their patients diagnosed with breast cancer and includes reporting powered by the Oncomine™ Knowledge Reporter. For more information about the Target Selector™ NGS Lung Panel, 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 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, the commercial success of our Target Selector™ NGS Breast Panel and the success of our collaboration with Prognos Health, Inc., 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 http://www.sec.gov/.

References:

[1] National Breast Cancer Foundation; https://www.nationalbreastcancer.org/breast-cancer-facts.

[2] Andre, F., Ismaila, N., Henry, N. L., Somerfield, M. R., Bast, R. C., Barlow, W., Collyar, D. E., Hammond, M. E., Kuderer, N. M., Liu, M. C., Poznak, C. V., Wolff, A. C., and Stearns, V. (2019) Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update—Integration of Results From TAILORx, Journal of Clinical Oncology 37, JCO.19.00945.

[3] Burstein, H. J., Lacchetti, C., Anderson, H., Buchholz, T. A., Davidson, N. E., Gelmon, K. A., Giordano, S. H., Hudis, C. A., Solky, A. J., Stearns, V., Winer, E. P., and Griggs, J. J. (2019) Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update, Journal of clinical oncology : official journal of the American Society of Clinical Oncology 37, 423-438.

[4] Giordano, S. H., Temin, S., Chandarlapaty, S., Crews, J. R., Esteva, F. J., Kirshner, J. J., Krop, I. E., Levinson, J., Lin, N. U., Modi, S., Patt, D. A., Perlmutter, J., Ramakrishna, N., Winer, E. P., and Davidson, N. E. (2018) Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Clinical Practice Guideline Update, Journal of clinical oncology : official journal of the American Society of Clinical Oncology 36, 2736-2740.

[5] Wolff, A. C., Hammond, M. E. H., Allison, K. H., Harvey, B. E., Mangu, P. B., Bartlett, J. M. S., Bilous, M., Ellis, I. O., Fitzgibbons, P., Hanna, W., Jenkins, R. B., Press, M. F., Spears, P. A., Vance, G. H., Viale, G., McShane, L. M., and Dowsett, M. (2018) Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update, Archives of pathology & laboratory medicine 142, 1364-1382.

Contact:
LHA Investor Relations
Jody Cain
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310-691-7100

SOURCE Biocept, Inc.

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