Aspira Women’s Health Announces Publication of Real-World Data Validating Use of OvaWatch for the Management of Adnexal Masses
07 January 2023 - 12:00AM
Aspira Women’s Health Inc. (“Aspira”), a bio-analytical based
women’s health company focused on gynecologic disease, today
announced its manuscript, entitled: “Validation of deep neural
network-based algorithm supporting clinical management of adnexal
mass,” has been published in the prestigious peer reviewed journal,
Frontiers in Medicine. The paper presents findings from the
multi-site clinical study of the company’s new assay, OvaWatch,
describing real-world evidence supporting the use of OvaWatch for
the clinical management of adnexal masses.
Conservative management of adnexal masses is warranted when
masses are clinically characterized as benign or indeterminate. Due
to the mortality risk associated with malignancy stemming from a
lack of noninvasive diagnostic tools, patients and healthcare
providers have often opted for a more aggressive surgical plan
resulting in potentially unnecessary surgery, pain for the patient,
and cost to an overburdened healthcare system.
In this multi-site clinical study, OvaWatch assay, was used to
examine malignancy risk in prospective and retrospective samples of
patients with an adnexal mass. In retrospective, low prevalence
(N=1453, 1.5% malignancy rate) data from patients that received an
independent physician assessment of benign, OvaWatch has a
sensitivity of 81.8% and specificity of 87.4% for identifying a
histologically confirmed malignancy, and a negative predictive
value (NPV) of 99.7%. OvaWatch identified 18/22 malignancies missed
by physician assessment. In the prospective real-world data set of
501 patients (2% malignancy rate), the NPV remained at 99%.
Additionally, in an independent analysis set with an intentionally
high malignancy rate (4%) the NPV was 88%. The consistently high
NPV indicates that OvaWatch can aid clinicians in the management of
women with an adnexal mass helping to add assurance that a mass has
low probability of malignancy.
“The data in this study confirm the validity of the test from
the previous retrospective cohorts,” said Dr. Ryan Phan, Chief
Scientific and Chief Operating Officer of Aspira and the senior
author of the study. “OvaWatch demonstrated a high NPV across
diverse data sets and clearly showed benefit as an effective test
supporting clinical management of suspected benign or indeterminate
masses.”
Nicole Sandford, President and CEO of Aspira added, “OvaWatch is
a major step forward for women facing a potential ovarian cancer
diagnosis, providing them with unprecedented peace of mind and
information to guide the decision of when – or even if – they
should have their ovaries removed. It is gratifying to see high
quality, real-world data confirming and further validating the
benefit of using OvaWatch as part of an experienced physician’s
treatment planning. Following the successful launch of OvaWatch
last quarter, healthcare providers now have a reliable tool within
our OvaSuite portfolio of blood tests for the more than 1.2 million
women a year that present with a pelvic mass. We are optimistic
that our products will become part of the standard physician
response for those women.”
About OvaWatchOvaWatch is a non-invasive,
multivariate index assay intended for use in the initial clinical
assessment of ovarian cancer risk in women with benign or
indeterminate adnexal masses. With a negative predictive value
(NPV) of 99%, OvaWatch allows physicians to confidently rule out
ovarian cancer malignancy and choose the right treatment for the
right patient at the right time.
Utilizing a clinically validated, proprietary algorithm that
incorporates seven serum biomarkers and patient features such as
age and menopause status, OvaWatch provides a personalized risk
assessment score and corresponding negative predictive value. A
lower risk score indicates a low probability of malignancy,
providing additional confidence in a clinician’s plan to manage and
monitor. A higher score does not indicate the presence of cancer;
rather, it may guide the clinician to consider additional clinical
assessment, specialist consultation or surgery.
About Aspira Women’s Health Inc.Aspira Women’s
Health Inc. is transforming women’s gynecological health with the
discovery, development, and commercialization of innovative testing
options for women of all races and ethnicities.
Ova1Plus® combines our FDA-cleared products, Ova1® and
OVERA®, to detect risk of ovarian malignancy in women with adnexal
masses planned for surgery. EndoCheckTM, Aspira’s first-of-its-kind
non-invasive diagnostic test for endometriosis, is currently in
development. Visit our website for more information
at www.aspirawh.com.
Forward-Looking StatementsThis
press release contains forward-looking statements, as defined in
the Private Securities Litigation Reform Act of 1995, including
statements regarding the potential effects of widespread use of
OvaWatch and the availability of OvaWatch in New York.
Forward-looking statements involve a number of risks and
uncertainties. Words such as “may,” “expects,” “intends,”
“anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,”
“should,” “continue,” “will,” “potential,” “projects” and similar
expressions are intended to identify forward-looking statements.
These forward-looking statements speak only as of the date of this
press release and are subject to a number of risks, uncertainties
and assumptions, including those described in the section entitled
“Risk Factors” in Aspira’s Annual Report on Form 10-K for the year
ended December 31, 2021, as supplemented by the section entitled
“Risk Factors” in Aspira’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022. These risks include, but are not
limited to: our ability to continue as a going concern; our ability
to comply with Nasdaq’s continued listing requirements; impacts
resulting from potential changes to coverage of Ova1 through our
Medicare Administrative Carrier for Ova1; impacts resulting from or
relating to the COVID-19 pandemic and actions taken to contain it;
anticipated use of capital and its effects; our ability to increase
the volume of our product sales; failures by third-party payers to
reimburse for our products and services or changes to reimbursement
rates; our ability to continue developing existing technologies and
to develop, protect and promote our proprietary technologies; plans
to develop and perform laboratory developed tests; our ability to
comply with Food and Drug Administration (“FDA”) regulations that
relate to our products and to obtain any FDA clearance or approval
required to develop and commercialize medical devices; our ability
to develop and commercialize additional diagnostic products and
achieve market acceptance with respect to these products; our
ability to compete successfully; our ability to obtain any
regulatory approval required for our future diagnostic products; or
our suppliers’ ability to comply with FDA requirements for
production, marketing and post-market monitoring of our products;
our ability to maintain sufficient or acceptable supplies of
immunoassay kits from our suppliers; in the event that we succeed
in commercializing our products outside the United States, the
political, economic and other conditions affecting other countries;
changes in healthcare policy; our ability to comply with
environmental laws; our ability to comply with the additional laws
and regulations that apply to us in connection with the operation
of ASPiRA LABS; our ability to use our net operating loss
carryforwards; our ability to use intellectual property; our
ability to successfully defend our proprietary technology against
third parties; our ability to obtain licenses in the event a third
party successfully asserts proprietary rights; the liquidity and
trading volume of our common stock; the concentration of ownership
of our common stock; our ability to retain key employees; our
ability to secure additional capital on acceptable terms to execute
our business plan; business interruptions; the effectiveness and
availability of our information systems; our ability to integrate
and achieve anticipated results from any acquisitions or strategic
alliances; future litigation against us, including infringement of
intellectual property and product liability exposure; and
additional costs that may be required to make further improvements
to our laboratory operations. The events and circumstances
reflected in Aspira’s forward-looking statements may not be
achieved or occur, and actual results could differ materially from
those projected in the forward-looking statements. Aspira expressly
disclaims any obligation to update, amend or clarify any
forward-looking statements whether as a result of new information,
future events or otherwise, except as required by law.
Investor Relations
Contact:Monique Kosse Managing DirectorLifeSci Advisors,
LLCTel: 212-915-3820
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