SAN DIEGO, Aug. 17, 2017 /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 cancer patients, announces it has entered into a clinical study agreement with the
University of Texas Southwestern Medical Center (UT Southwestern Medical Center). Led by recognized
oncologist and ALK mutation researcher Dr. Saad Khan, the study is designed to evaluate the
clinical utility of Biocept's Target Selector™ platform for patients diagnosed with ALK-positive non-small cell lung
cancer and treated with ALK-inhibitor therapy. A second arm of the study will evaluate patients with rare cancers such as
anaplastic thyroid cancer to determine if driver mutations such as ALK rearrangements can be identified and treated with
targeted therapy to improve patient outcomes.
"Identifying ALK rearrangements in patients with lung cancer has become important as new targeted therapies are
available to help manage disease in patients harboring this type of alteration," said Saad Khan,
MD, Medical Oncologist and Assistant Professor of Internal Medicine at UT Southwestern Medical Center. "We have designed this
study to demonstrate the ability to rapidly identify ALK rearrangements, and to provide further evidence that patients
with both non-small cell lung cancer and rare cancers harboring ALK alterations can benefit from targeted therapy and
serial monitoring of ALK and other key alterations."
"Demonstrating the clinical utility of our Target Selector™ platform in studies conducted by top researchers like Dr. Khan is
important to expand the clinical adoption of our liquid biopsy offering in oncology," said Biocept's President and Chief
Executive Officer Michael Nall. "We continue to evaluate our Target Selector™ platform in clinical
studies in which the identification of ALK fusions and other alterations with our assays can help guide treatment
decisions resulting in improved patient outcomes. Our Target Selector™ tests can be used to help physicians rapidly obtain the
actionable information they need to design personalized treatment plans for their cancer patients."
About ALK Rearrangements in Lung Cancer
The ALK gene encodes the anaplastic lymphoma kinase (ALK) protein, which belongs to a family of receptor
tyrosine kinases involved in transmitting cell surface signals to the inside of the cell. In approximately 5% of non-small cell
lung cancer patients, a portion of the ALK gene is abnormally rearranged when DNA is replicated during cell division.
Fusion of ALK DNA sequences to another gene results in the disruption of normal ALK protein function, causing uncontrolled
cell growth as is characteristic in cancer. Various ALK gene arrangements, or translocations, have been observed in NSCLC;
the majority of variants involve gene fusions between the ALK and EML4 genes. Biocept's Target Selector™ platform
is able to identify ALK translocations in circulating tumor cells (CTCs) using fluorescence in situ hybridization (FISH)
probes that are also commonly used for molecular profiling in tissue. Non-small cell lung cancer patients who test positive for
an ALK fusion are likely to respond to ALK inhibitor therapy such as Xalkori® (crizotinib). Biocept's liquid biopsy
testing may be used to identify ALK translocations to guide treatment decisions and selection of an appropriate targeted
therapy.
About Biocept
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and
prostate cancers, and melanoma. The Company leverages its proprietary liquid biopsy technology to provide physicians with
clinically actionable information for treating and monitoring patients diagnosed with cancer. Biocept's patented Target
Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor
cells (CTCs) and in circulating tumor DNA (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 news 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 be 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 news release are not strictly
historical, including, without limitation, statements as to our ability to improve the outcomes of cancer patients, the success
of the UT Southwestern Medical Center study and its ability to meet its objectives, our ability to further validate our liquid
biopsy technology, and our ability to increase the clinical adoption of our testing services, 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 news 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 at www.sec.gov
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SOURCE Biocept, Inc.