Aspira Women’s Health Inc. (“Aspira”), a bio-analytical based
women’s health company focused on gynecologic disease, today
announced that the 2023 Omnibus Spending Bill passed by Congress
and awaiting President Biden’s signature contains language
directing the Center for Medicare & Medicaid Services (CMS) to
cover multi-marker tests for ovarian cancer. The company believes
all of its commercially available ovarian cancer risk assessment
blood tests would fall under the recommended coverage expansion,
which is expected to significantly increase access for women with
pelvic masses in both Medicare and Medicare Advantage plans. It
also sets the stage for commercial payers to adopt similar coverage
policies.
Connecticut Rep. Rosa DeLauro, Chair of the House Appropriations
Committee stated, “The fight against ovarian cancer is very
personal to me. I am a more than 30-year survivor of the disease,
but consider myself lucky that it was caught and treated early. The
reality is that for too many women, gaps in ovarian cancer
diagnostics and care still remain, and to save lives we must change
this. That is why the 2023 government funding bill
increases funding for research and puts ovarian cancer multimarker
testing directly on the path to CMS coverage, so more women can
gain access to care.”
Nicole Sandford, President and CEO of Aspira, added, “Aspira is
proud to have participated with clinicians, women’s health advocacy
groups, and most importantly, patients, to raise Congressional
awareness about the need for broader access to clinically superior
ovarian cancer tests. We believe this is critical for improving
outcomes for women with ovarian cancer, and are firmly committed to
the cause.”
Valerie Palmieri, Executive Chair of Aspira’s Board of Directors
noted, “This was truly a patient-centric effort. Patient insights
and input were included every step of the way as the bill was
constructed. I want to personally acknowledge Diane Powis, the
Company’s Chief Spokeswoman, who advocated for this legislation
right up until the day she lost her battle with ovarian cancer in
December 2021. Her effort to raise awareness of this devastating
disease among lawmakers was truly heroic. This is a proud day for
Diane’s family, and a proud day for Aspira.”
Aspira also announced that it has expanded Ova1Plus Medicaid
access in five states during 2022 including: Virginia, Alabama,
Maine, Pennsylvania, and Rhode Island. Broadening Medicaid coverage
is consistent with the Company’s goal of making OvaSuite products
available and affordable to all women regardless of socioeconomic
status. Aspira has now secured Medicaid coverage in 27 states,
representing 77% of Medicaid lives.
Lastly, the Company announced the American Medical Association
(AMA) has approved a new Proprietary Laboratory Assay (PLA) code
for OvaWatch, the Company’s recently launched non-invasive ovarian
cancer risk assessment for use in the initial clinical assessment
of adnexal masses. The PLA code will be used to bill all payers
effective April 1, 2023. A PLA code uniquely identifies OvaWatch,
distinguishing it from other tests and allowing for a more
streamlined reimbursement process.
Greg Richard, Senior Vice President of Market Access and
Business Development at Aspira, stated, “Expanding insurance
coverage for our OvaSuite product portfolio is critical to improved
patient outcomes and to Aspira’s success. Each of these three
milestones – the advancement of national Medicare coverage for
multi-marker tests through the Omnibus Spending Bill, expanded
Medicaid coverage in five new states, and the establishment of a
PLA Code for OvaWatch - are each important achievements in their
own right. Taken together, though, they demonstrate powerful
momentum towards achieving our reimbursement and access goals for
both Ova1Plus and OvaWatch.”
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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