Aspira Women’s Health announces the publication of a paper validating the OvaWatch™ algorithm in detecting ovarian cancer

Aspira Girls’s Well being Inc.

A paper revealed within the June on-line challenge of JCO Scientific Most cancers Informatics

AUSTIN, Texas, June 16, 2022 (GLOBE NEWSWIRE) — Aspira Girls’s Well being Inc. (“Aspira”), a ladies’s well being bioanalytical firm centered on gynecology, right now introduced the publication of on-line analysis confirming the validity of the OvaWatch™. An algorithm in detecting ovarian most cancers within the June challenge of JCO Scientific Most cancers Informatics.

The paper is entitled:Analytical validation of a deep neural community algorithm for ovarian most cancers detectionDemonstrates the potential of OvaWatch in precisely assessing the chance of ovarian malignancy in sufferers with pelvic lots. Ovarian most cancers is likely one of the most harmful forms of gynecological cancers, with most circumstances identified at a late stage. Early detection of ovarian most cancers is essential to serving to cut back Mortality fee; nonetheless, present non-invasive threat evaluation measures available on the market differ of their usefulness.

“There’s a super want for early detection and stratification of ovarian most cancers, particularly for girls with adnexal clumps. It has been demonstrated that OvaWatch will help consider therapy methods, addressing lots of the limitations of present biomarker-based blood exams,” he stated. Dr. Gerard Riley, Director of Scientific Analysis and Innovation at Axia Girls’s Well being and one of many lead authors of the paper. “The widespread use of this noninvasive check may assist consider acceptable care methods for sufferers with a pelvic mass.”

Nicole Sandford, CEO of Aspira Girls’s Well being, stated: “We’re very happy to see the outcomes of this examine revealed in a good journal. As soon as launched, we consider our OvaWatch threat evaluation will turn into a beneficial instrument to assist clinicians decide acceptable therapy methods for every lady with an appendix mass, And its adoption has the potential to enhance well being outcomes for girls with ovarian most cancers.”

About Aspira Girls’s Well being Inc.
Aspira Girls’s Well being Inc. Reworking ladies’s well being by discovering, creating, and commercializing modern testing choices and bioanalytical options that assist clinicians assess dangers, enhance affected person administration, and enhance ladies’s well being outcomes. Aspira Girls’s Well being locations particular emphasis on bridging the racial disparity in ovarian most cancers threat evaluation and creating options for pelvic ailments reminiscent of mass pelvic threat evaluation and endometriosis. OVA1plus™ combines our FDA-approved merchandise, OVA1® and OVERA®, to display screen for the chance of ovarian malignancy in ladies with adnexal lots. The Aspira GenetiX™ Take a look at gives each complete and focused genetic testing choices with a gynecological focus. With greater than 10 years of expertise assessing ovarian most cancers threat, Aspira Girls’s Well being delivers a variety of pelvic mass merchandise over a affected person’s lifetime via our cutting-edge analysis. The subsequent era of merchandise in growth embody OvaWatch™ and EndoCheck™. To enhance affected person entry, Aspira Girls’s Well being not too long ago launched the Aspira Synergy™ know-how switch platform to allow well being techniques, teachers, regional labs, and doctor group labs to conduct genetic and specialty testing in-house. Go to our web site for extra data at www.aspirawh.com.

forward-looking statements
This press launch incorporates forward-looking statements, as outlined within the Non-public Securities Litigation Reform Act of 1995, together with statements relating to expectations or projections relating to future check volumes, income, value of income, working bills, analysis and growth expenditures, gross margin and money flows. money, outcomes of operations and monetary place; Our plan to broaden our business focus from ovarian most cancers to the differential prognosis of girls with a variety of gynecological situations, together with extra pelvic ailments reminiscent of endometriosis and benign pelvic mass monitoring in addition to genetic threat evaluation, together with breast and ovarian most cancers threat evaluation and provider screening; Deliberate enterprise technique and projected strategic enterprise drivers and impacts, together with partnerships reminiscent of these primarily based on the Aspira Synergy product, in addition to different methods, collaboration and licensing samples; We plan to broaden our present OVA1, OVERA, OVA1plus, Aspira GenetiX and Aspira Synergy merchandise on a worldwide degree, launching and advertising our new merchandise, OvaWatch (previously OVASight), EndoCheck and OVAInherit; plans to develop new algorithms, molecular diagnostic exams, merchandise and instruments, and broaden our product choices, together with plans to develop a product utilizing genetics, proteomics, and different strategies to evaluate most cancers threat when carrying a pathogen variant related to hereditary breast and ovarian most cancers that’s troublesome to detect with a diagnostic check; Plans to create payer protection and individually safe Aspira GenetiX, OvaWatch, EndoCheck and OVAInherit contracts and broaden present protection and contract insurance coverage for OVA1; plans that might handle scientific questions associated to early detection of illness, response to therapy, monitoring of illness development, prognosis, and different points within the fields of oncology and girls’s well being; the anticipated effectiveness of our merchandise, product growth actions, and product improvements, together with our potential to enhance sensitivity and specificity over conventional diagnostic biomarkers; anticipated competitors within the markets through which we compete; Plans associated to ASPiRA LABS, together with plans to broaden or improve ASPiRA LABS testing capabilities; expectations relating to the continuation of future companies offered by Quest Diagnostics Integrated; plans to develop informatics merchandise and to develop and conduct Developed Laboratory Checks (“LDTs”); FDA oversight modifications to lab-developed exams; Plans to develop a racial or ethnic group pelvic threat evaluation; expectations relating to present and future collaboration and partnerships for our merchandise, together with plans to enter right into a decentralized association for the Aspira Synergy product; plans for future publications; expectations relating to potential collaboration with governments, legislatures, and advocacy teams to advertise consciousness and drive coverage to supply broader entry to our exams; our potential to proceed to adjust to relevant authorities rules, expectations relating to pending regulatory filings and plans to acquire regulatory approvals for our exams inside the USA and internationally, as relevant; Our continued potential to broaden and defend our mental property portfolio; anticipated liquidity, capital necessities, future losses and our potential to proceed as a going concern; expectations relating to the capital improve and the anticipated quantity of funding required to fund our deliberate operations; expectations relating to the outcomes of our scientific analysis research and our potential to recruit sufferers to take part in such research; Our potential to make use of internet carry-forward working losses and foreseeable future tax legal responsibility underneath US federal and state earnings tax laws; anticipated market adoption of our diagnostic exams, together with OVA1, OVERA and OVA1plus, in addition to our choices for the Aspira GenetiX and Aspira Synergy platform; expectations relating to our potential to launch, license, co-market or purchase new merchandise that we develop; expectations relating to the scale of the markets for our merchandise; expectations relating to reimbursement for our merchandise, and our potential to acquire such reimbursement, from different payers reminiscent of non-public insurance coverage firms and state insurance coverage; Plan to make use of each AbbVie Inc serum samples. and ObsEva SA plasma samples in EndoCheck product validation research; Plans relating to EndoCheck whether or not or not the Meals and Drug Administration classifies it as a breakthrough gadget; Anticipated goal launch timing for OvaWatch and Endocheck; Expectations relating to compliance with federal and state legal guidelines and rules relating to billing preparations made in coordination with laboratories; Plan to advocate for laws {and professional} neighborhood steerage to broaden entry to our services and products; and expectations relating to the results of or attributable to the COVID-19 pandemic and the actions taken to comprise it. Ahead-looking statements contain quite a lot of dangers and uncertainties. Phrases reminiscent of “might,” “count on,” “intend,” “count on,” “consider,” “estimate,” “plan,” “search,” “may,” “ought to,” “proceed,” “will,” purpose “Tasks” and comparable expressions restrict forward-looking statements. These forward-looking statements communicate solely as of the date of this press launch and are topic to quite a lot of dangers, uncertainties and assumptions, together with these described within the “Threat Elements” part of Aspira’s annual report on Type 10-Ok For the yr ended December 31, 2020, as supplemented by the part titled “Threat Elements” in Aspira’s Quarterly Report on Type 10-Q for the quarter ended June 30, 2021. Occasions and circumstances described in Aspira’s forward-looking statements might not materialize or happen and precise outcomes might differ materially Aspira expressly disclaims any obligation to replace, amend or make clear any forward-looking statements, whether or not because of new data, future occasions or in any other case, besides as required by regulation.

Investor Relations Contact:
Ashley R. Robinson
LifeSci Consultants, LLC
Cellphone 617-535-7742