SAN DIEGO, Feb. 9, 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
that President and CEO Michael W.
Nall has issued the following letter to stockholders:
To Our Stockholders and Friends:
The entire team at Biocept looks forward to 2017, as we work to
advance our position as a commercial leader in liquid biopsy.
The past year was eventful as we introduced new high-value
biomarker assays, signed in-network provider agreements with major
health plans, and reported positive clinical study results that
further validate our Target Selector™ platform. It was
gratifying to see these accomplishments reflected in our improved
operational and financial performance, with strong year-over-year
growth in sample volumes and the achievement of our first
million-dollar quarter in the third quarter of 2016.
Among our notable achievements, we commercialized our liquid
biopsy test for PD-L1 protein expression last June. The
determination of PD-L1 status is necessary to qualify patients for
certain targeted immuno-oncology therapeutics. This test was well
received by the medical community and physician demand has been
strong since its launch. The quantification of protein
expression for tests like PD-L1 is performed on circulating tumor
cells (CTCs) and cannot be determined from circulating tumor DNA
(ctDNA). This is an example of how our Target Selector™
dual-platform, which analyzes cancer biomarkers found on CTCs and
in ctDNA, can provide a more comprehensive answer than other liquid
biopsy tests that only analyze ctDNA.
We started 2017 by announcing an in-network agreement with the
largest health plan in Texas. This
is a significant milestone for Biocept, as Texas is one of our largest markets. Today, I
am pleased to report that we also recently entered into a
group-purchasing agreement with a large, national health plan
association. This agreement substantially increases the opportunity
for Biocept to enter into additional in-network agreements with
member plans throughout this network. The selection of our liquid
biopsy offering resulted from a rigorous RFP process conducted by
the health plan association, and establishes pricing for member
plans that wish to contract with Biocept.
We also began 2017 with improvements in billing and collections
as a result of the numerous actions we've taken to improve this
aspect of our business. This effort is led by our CFO and
Senior Vice President of Operations Tim
Kennedy, who joined us last July and brings significant
experience in this function. Tim and his team continue to
make strides in streamlining our billing and operating
procedures.
This year we expect to deliver on another significant milestone
in the accounting function with our anticipated transition to
accrual accounting, rather than our current method of reporting
revenue on a cash basis. Accrual accounting will allow us to
record revenues as our tests are performed, thereby providing for a
more timely reflection of revenue associated with our test volume,
and better alignment of revenues and expenses.
I'm pleased to share our priorities for 2017, which are aimed at
growing our customer base, driving test volumes, and further
building our leadership position.
These include:
- increasing the number of physicians ordering our liquid biopsy
tests and expanding test volumes from our current base of
accounts;
- signing additional health plan agreements to support
third-party reimbursement for our tests;
- collaborating with top-tier oncology institutions to expand the
commercial adoption of our liquid biopsy platform, and to conduct
clinical studies that further validate the use of our tests;
- broadening our test menu with the introduction of new
clinically actionable oncology biomarker assays; and
- forming partnerships in the U.S. and overseas to expand the
distribution of our tests.
We look forward to reporting our progress on these priorities
throughout the year.
We are optimistic about our future for numerous reasons
including that we are an established player in a market that Wall
Street analysts' project to exceed $10
billion by 2025. Our liquid biopsy tests are aligned
with today's healthcare environment in which practitioners and
providers seek to improve patient outcomes while reducing the cost
of care. Compared with invasive tissue biopsies, our tests
provide a non-invasive, cost-effective and accurate means of
detecting and monitoring oncology biomarkers with the use of a
simple blood sample. Clinical studies continue to validate
our technology for high clinical sensitivity and concordance with
tissue biopsy.
Importantly, there are four key areas of our business that we
believe provide Biocept with a sustainable competitive advantage in
the liquid biopsy market.
- First, our Target Selector™ dual-platform features a
comprehensive menu of assays focused only on clinically validated
cancer biomarkers, which is key to oncologists and their patients
for tumor profiling and cancer monitoring. This menu uniquely
includes tests for oncogenic mutations, gene fusions,
amplifications, translocations, and proteins.
- Second, our CTC and ctDNA platforms leverage our proprietary
biomarker enrichment technologies, resulting in industry-leading
test performance.
- Third, our liquid biopsy solutions are cost-effective given
their application in clinically actionable situations and their
alignment with payer reimbursement policies. This increases the
efficiency of our claims collections and assists in expanding the
in-network coverage of Target Selector™ with major health plans
that reimburse based on clinical utility, medical necessity, and
cost.
- And lastly, our technologies are amenable to the development of
Target Selector™ in vitro diagnostic (IVD) kits, allowing
our liquid biopsy tests to be performed in laboratories around the
world.
Later this year, we plan to initiate a commercial pilot program
that will enable hospital-based pathologists to interpret the
results of our liquid biopsy tests locally. This strategy is
anticipated to increase the uptake of our novel testing platform by
engaging molecular pathologists in hospital systems across the
country. We also plan to initiate a clinical study for our
Target Selector™ microchannel technology, which is the first step
toward the development of our IVD kits. Our kit strategy will take
time to develop and launch, given the requirement to conduct a
clinical trial and obtain the necessary regulatory approvals.
Nevertheless, by developing IVD kits based on our Target Selector™
technology, there is an opportunity to substantially leverage our
liquid biopsy brand and expand our test volumes, our sales, and our
operating margins in the future.
In closing, we have set forth a pathway to build on our many
accomplishments, and seek to deliver additional value to patients,
customers and our shareholders in 2017. On behalf of my
colleagues, our Board, and our advisors, thank you for your
continued support of Biocept.
Sincerely,
Michael W. Nall
President and Chief Executive Officer
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 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 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
diagnosis and treatment of cancer, our ability to advance our
position as a commercial leader in liquid biopsy, our ability to
increase physician demand for our tests, our ability to transition
to accrual accounting in 2017, our ability to implement our
priorities in 2017 and their ability to grow our customer base,
drive test volume and build our leadership position, the
anticipated commercial opportunity of the liquid biopsy market, our
ability to develop our IVD kit business, and our ability to enter
into clinical studies to further validate the use of our tests,
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.
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SOURCE Biocept, Inc.