Biocept Issues Letter to Stockholders
To My Fellow Stockholders:
Oncology testing is our foundation for long-term success. We are proud to provide critical information to help physicians select the optimal treatment for their patients with cancer.
Among key initiatives for the coming year is to advance our Target Selector™ CSF assays toward standard of care for diagnosing and monitoring central nervous system metastases. This unique offering afforded by our proprietary rare cell capture technology platform presents an opportunity to serve a sizable market with more than 100,000 patients per year diagnosed with metastatic tumors to the brain in the
Focus on Neuro-Oncology
Last year we launched our Target Selector™ CSF assays for diagnosing and monitoring lung and breast cancer that has metastasized to the brain and central nervous system. Depending on the type of cancer, between 10% and 30% of adults with cancer will develop brain metastases. Detecting metastases in CSF is critical as advances in treatment strategies and new targeted therapies are helping patients with this type of metastatic cancer to live significantly longer.
Our new assays fill a significant market need as the current standard of care, CSF cytology, has very limited sensitivity to detect metastases and provides no information about molecular targets for therapy choice. Further, CSF cytology frequently results in negative results when tumor involvement of the central nervous system is suspected, which often leads to repeat attempts to collect CSF samples from lumbar punctures. Our initial studies show that Target Selector™ allows for a more sensitive, cell-specific and quantitative assessment of tumors in CSF, allowing for the diagnosis of metastases and providing information about molecular alterations that can aid in the choice of therapy.
We are beginning to gain recognition within the medical community as our study results were featured at several major international scientific meetings last year. Additional initiatives underway to support physician adoption include working with key opinion leaders as study collaborators to further establish the clinical utility of our Target Selector™ CSF assays and advance our assays toward standard of care. While CSF assays currently represent a small percentage of our business, we expect volumes to continue to increase each quarter as we progress through 2021.
This groundbreaking work in CSF and overall advancements with our oncology business are being led by
Update on Oncology Testing Business
Like other molecular biology companies, our oncology testing business has been impacted by the pandemic. We fully expect test volumes will return to historical levels as the pandemic subsides. In the meantime, our strategy is to take actions that position us for a strong future. Among these is entering into new provider agreements with integrated health systems and other capitated plans that provide quality healthcare delivered cost-effectively. By using a liquid biopsy with blood or CSF, our oncology assays are a cost-efficient means to profile for biomarkers that impact therapy and to monitor disease progression over time.
As a notable win last year, we signed an agreement for all Target Selector™ assays with
Update on COVID-19 Testing Initiatives
To date we have been purchasing the components for COVID-19 collection kits from third parties, assembling the kits in-house and distributing them to customers. Last year we announced our intention to develop our own COVID-19 specimen collection media. We have received independent validation that the
We are now in the process of completing the final validation and testing phase of the COVID-19 assay development project with Aegea Biotechnologies and we expect the assay to be ready for deployment in clinical testing laboratories in the first quarter of 2021. The Aegea COVID-19 assay will utilize the patented Switch-Blocker technology. This COVID-19 assay incorporates several unique features that could potentially aid caregivers in their clinical decision. Those capabilities include the ability to determine which COVID-19 strain is present, which may be important in determining therapeutic strategy. Also the assay is quantitative so physicians can measure the viral load, which can potentially be used to monitor disease progression. When development is complete,
Beyond our COVID-19 initiatives, corporate priorities for our core oncology business in 2021 are as follows:
- Increasing market penetration of Target Selector™ assays with a focus on neuro-oncology, in addition to urology, breast and lung cancer;
- Entering into additional studies with respected institutions to further prove the clinical utility of our offerings;
- Publishing clinical case studies and presenting data at scientific conferences that further validate our Target Selector™ testing;
- Growing sales of our Target Selector™ molecular assay research-use only (RUO) kits and our CEE-Sure blood collection tubes;
- Receiving payment from Medicare for our Target Selector™ NGS assay developed under our collaboration with Thermo Fisher;
- Entering into additional strategic commercial and technology partnerships, both global and domestic;
Signing additional agreements with third-party health plans including capitated plans, and expanding our relationship within the
Blue Cross Blue Shieldnetwork;
- Launching additional assays both in blood and CSF; and
Strengthening our patent portfolio in the
To support our many priorities, we are fortunate to have resources aligned to pursue these markets. In addition, we recently relocated to a new facility in
I am so very proud of our hard-working team at
President and Chief Executive Officer
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 regarding the ability of our assays to provide physicians with clinically actionable information to improve patient outcomes, our ability to advance our Target Selector™ CSF assays toward standard of care for diagnosing and monitoring central nervous system metastases, anticipated revenues for full year 2020, our expectations regarding COVID-19 testing as a component of our business during 2021, our expectations regarding volumes of CSF assays during 2021, our expectations regarding oncology test volumes returning to historical levels as the pandemic subsides, the timing of availability of
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