BioTime Inc. Affiliate Company OncoCyte Corporation Reports Successful Results With DetermaVu™ Diagnostic Test for Lung Can...
30 1월 2019 - 10:00PM
BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology
company focused on degenerative diseases, today announced that its
affiliate company, OncoCyte Corporation (OncoCyte)
(OCX), a developer of novel,
non-invasive tests for the early detection of cancer, has reported
positive results from an R&D validation study of DetermaVu™, a
non-invasive, liquid biopsy test intended to facilitate clinical
decision making in lung cancer diagnosis. As outlined in OncoCyte’s
announcement, the R&D validation study demonstrated a
sensitivity of 90% (95% CI 82%-95%) and specificity of 75% (95% CI
68%-81%) of DetermaVu™ on a prospectively collected cohort of 250
patient blood samples that were blinded to laboratory operators. A
95% confidence interval (CI) suggests that there is a 95% chance
that test performance will be within the stated range.
According to OncoCyte, these results indicate
that DetermaVu™ significantly exceeds the critical parameters
necessary for use in lung cancer diagnosis and clearly outperforms
reported results from competitors’ tests and other clinical models.
OncoCyte believes that the potential U.S. market opportunity for
DetermaVu™ is $4.7 billion. OncoCyte intends to make
DetermaVu™ commercially available in the second half of
2019.
“As the largest shareholder of OncoCyte, we wish
to congratulate the entire team on obtaining positive results from
the validation study of DetermaVu™ which were announced yesterday
morning,” stated Brian M. Culley, Chief Executive Officer of
BioTime, Inc. “BioTime owns approximately 36% of Oncocyte’s
outstanding common stock and we look forward to the commercial
launch of DetermaVu™ which OncoCyte expects to occur later this
year.”
DetermaVu™ is OncoCyte’s confirmatory,
non-invasive, liquid biopsy test intended to facilitate clinical
decision making in lung cancer diagnosis. DetermaVu™ is being
developed as a confirmatory test for presence or absence of lung
cancer to reduce the need for unnecessary invasive biopsies when
suspicious lung nodules are detected by imaging modalities such as
x-rays or other scans. DetermaVu™ is a trademark of OncoCyte
Corporation.
About OncoCyte Corporation OncoCyte is focused
on the development and commercialization of novel, non-invasive
blood and urine (“liquid biopsy”) diagnostic tests for the early
detection of cancer. Early detection of cancer can improve health
outcomes, reduce the cost of care, and improve patients’ quality of
life. Liquid biopsy diagnostic tests like those OncoCyte is
developing may reduce the need for costlier and riskier diagnostic
procedures such as invasive biopsy procedures. OncoCyte’s is
focusing its efforts on developing DetermaVu™ as a non-invasive
confirmatory diagnostic test for lung cancer. DetermaVu™ is being
developed using proprietary sets of genetic and protein molecular
markers to detect the presence of lung cancer. OncoCyte also plans
to conduct research to identify additional molecular markers,
acquire or license markers and related technology, and develop
cancer tests based on those markers.
About BioTime, Inc.
BioTime is a clinical-stage biotechnology company focused on
the development and commercialization of novel therapies for the
treatment of degenerative diseases. BioTime’s pipeline is based on
two platform technologies which encompass cell replacement and
cell/drug delivery. BioTime’s lead cell replacement product
candidate is OpRegen®, a retinal pigment epithelium transplant
therapy in Phase 2 development for the treatment of dry age-related
macular degeneration, the leading cause of blindness in the
developed world. BioTime’s lead cell delivery clinical program is
Renevia®, an investigational medical device being developed as an
alternative for whole adipose tissue transfer procedures.
BioTime common stock is traded on the NYSE American and TASE
under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company on
Twitter, LinkedIn, Facebook, YouTube, and Google+. To
receive ongoing BioTime corporate communications, please
click on the following link to join the Company’s email alert
list: http://news.biotime.com.
Forward-Looking
StatementsCertain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Any statements that are
not historical fact including, but not limited to statements that
contain words such as “will,” “believes,” “plans,” “anticipates,”
“expects,” “estimates” should also be considered forward-looking
statements. Forward-looking statements involve risks and
uncertainties. Actual results may differ materially from the
results anticipated in these forward-looking statements and as such
should be evaluated together with the many uncertainties that
affect the business of BioTime, Inc. and its subsidiaries,
particularly those mentioned in the cautionary statements found in
more detail in the “Risk Factors” section of BioTime’s Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q (copies of
which may be obtained at www.sec.gov). Subsequent events and
developments may cause these forward-looking statements to change.
BioTime specifically disclaims any obligation or intention to
update or revise these forward-looking statements as a result of
changed events or circumstances that occur after the date of this
release, except as required by applicable law.
BioTime Inc. IRIoana C.
Hone(ir@biotimeinc.com)(510) 871-4188
Solebury Trout IRGitanjali Jain Ogawa
(Gogawa@troutgroup.com) (646) 378-2949
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