About Aspira Women's Health
Aspira Women’s Health Inc., together with its subsidiaries, engages in developing and commercializing diagnostic tests for gynecologic disease in the United States The company markets and sells the following products and related services: Ova1, a blood test intended as an aid to further assess the likelihood of malignancy in women with an ovarian adnexal mass for which surgery is planned when the physician’s independent clinical and radiological evaluation does not indicate malignancy; Overa, a second-generation biomarker reflex intended to maintain Ova1’s high sensitivity while improving specificity; Ova1Plus, a reflex offering which uses Ova1 as the primary test and Overa as a confirmation for Ova1 intermediate range results; and OvaWatch, a lab developed blood test intended to assist in the initial clinical assessment of malignancy risk in all women with an adnexal mass. Collectively, these tests are referred to and marketed as OvaSuite. For the year ended December 31, 2022, the company’s product and related revenue was limited to these products, and Aspira GenetiX which was discontinued in the third quarter of 2022. The company’s products are distributed through its own national sales force, through its proprietary decentralized testing platform and cloud service marketed as Aspira Synergy, and through a marketing and distribution agreement with BioReference Health, LLC. The company’s focus on translational biomarkers and informatics enables it to address the market for novel diagnostic tests that simultaneously measure multiple biomarkers. A biomarker is a biomolecule or variant biomolecule (e.g., DNA, RNA or protein) that is present at measurably greater or lesser concentrations, or is present in an altered form, in a disease state versus a normal condition. Conventional protein tests measure a single protein biomarker whereas most diseases are complex. The company’s Ova1 test received FDA de novo classification in September 2009. Ova1 comprises instruments, assays, reagents, and the OvaCalc software, which includes a proprietary algorithm that produces a risk score. The company’s Overa test, which includes an updated version of OvaCalc, received FDA 510(k) clearance in March 2016. Ova1, Overa and OvaWatch, the company’s first LDT, each use the Roche Cobas 4000, 6000 and 8000 platforms for analysis of proteins. Revenue from these sources (in addition to revenue from Aspira GenetiX, which was discontinued in September 2022) is included in the results of operations in total revenue for the year ended December 31, 2022. In 2021, the company began entering into decentralized arrangements with large healthcare networks and physician practices for its Aspira Synergy platform, its decentralized testing platform and cloud service for decentralized global access of protein biomarker testing. Ova1, Overa, and Ova1Plus continue to be available through the Aspira Synergy platform. The company has entered into four technology transfer agreements since the launch of Aspira Synergy. Two of the agreements are with independent regional laboratories and are in the process of being launched and piloted. OvaWatch has been developed and is validated for use in Aspira’s CLIA-certified lab as a non-invasive blood-based risk assessment test for use in conjunction with clinical assessment and imaging to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. The commercialization plan for OvaWatch will occur in two phases. Outside of the United States, the company has sponsored studies in both the Philippines and Israel, which are intended to validate Overa and Ova1 in specific populations. In June 2022, a manuscript arising from clinical research efforts in the Philippines, which the company sponsored, was accepted for publication in the International Journal of Environmental Research and Public Health. The company owns and operates Aspira Labs, based in Austin, Texas, a Clinical Chemistry and Endocrinology Laboratory accredited by the College of American Pathologists, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. Aspira Labs provides expert diagnostic services using a state-of-the-art biomarker-based risk assessment to aid in clinical decision making and advance personalized treatment plans. The lab performs the company’s Ova1, Overa, Ova1Plus, and OvaWatch testing, as well as additional tumour and hormone tests, and it plans to expand the testing to other gynecologic conditions with high unmet need. Aspira Labs holds a CLIA Certificate of Accreditation and a state laboratory license in California, Maryland, New York, Pennsylvania and Rhode Island. In the United States, revenue for diagnostic tests comes from several sources, including third-party payers such as insurance companies, government healthcare programs, such as Medicare and Medicaid, client bill accounts and patients. Novitas Solutions, a Medicare contractor, covers and reimburses for Ova1 tests performed in certain states, including Texas. Due to Ova1 tests billed by the company being performed exclusively at Aspira Labs in Texas, the local coverage determination from Novitas Solutions essentially provides national coverage for patients enrolled in Medicare, as well as Medicare Advantage health plans. Aspira Labs also bills third-party commercial and other government payers, as well as client bill accounts and patients for Ova1. The company is well positioned to introduce new gynecologic diagnostic products and it plans to expand its product offerings to additional women’s gynecologic health diseases by adding additional gynecologic bio-analytic solutions involving biomarkers, genetics, other modalities (e.g., imaging), clinical risk factors and patient data to aid diagnosis and risk stratification. Future product expansions will be accelerated by the development of lab developed testing in a CLIA environment, or relationships with strategic research and development partners, and access to specimens in its biobank. OvaWatch is a non-invasive blood-based risk assessment test to determine ovarian cancer risk for patients with an adnexal mass whose adnexal mass has been determined by an initial clinical assessment as indeterminate or benign. OvaWatch is designed to support a physician’s planned clinical management through additional clinical data at the time of initial assessment, and by potentially monitoring - in conjunction with ultrasounds and other clinical assessments – to safely decrease or delay unnecessary surgery. OvaWatch was designed for launch in two stages. Phase I, which was launched during the fourth quarter of 2022 is a single use point in time test, and Phase II will allow for serial monitoring. The launch of the serial monitoring test is targeted for 2023 upon obtaining sufficient data from the ongoing prospective serial monitoring clinical study. Phase I of the OvaWatch test has a 99% negative predictive value, which will allow physicians to initially assess and serially monitor women with a mass to safely delay or reduce premature or unnecessary surgery. EndoCheck, an in-development non-invasive blood test to be used in conjunction with other non-surgical modalities, is designed as an aid in the identification of endometriosis to guide clinical care for patients with suspected endometriosis earlier in their prognosis journey. Detection methods for endometriosis require surgery and a surgical biopsy diagnosis and/or visualization diagnosis. EndoCheck is intended to address this large patient population by using a non-invasive solution with comparable sensitivity and specificity when compared to invasive methods, such as surgical biopsy and/or visualization. The company ultimately plans to commercialize OvaSuite and EndoCheck on a global scale and hold CE marks for Ova1 and Overa. In June 2022, in connection with its global expansion plans, a manuscript arising from clinical research efforts in the Philippines, which it sponsored, was accepted for publication in the International Journal of Environmental Research and Public Health. Commercialization and Distribution The company markets and distributes its products through a national sales team, the Aspira Synergy cloud-based technology transfer platform, and various commercial partnerships. In October 2022, the company launched a co-marketing and distribution collaboration with BioReference Health, LLC, a subsidiary of OPKO Health, Inc. (BRL), as a new channel for volume growth. Under terms of the agreement, the Aspira and BioReference sales teams will collaborate to sell Ova1Plus to gynecologists and other women’s healthcare providers nationwide. Starting in 2014, the company offered Ova1 via Aspira Labs. In March 2015, the company entered into a commercial agreement with Quest Diagnostics Incorporated. The company has active international distribution agreements for Overa with Pro-Genetics LTD in Israel and MacroHealth, Inc. in the Philippines. Customers In the United States, the company’s clinical customer base can be segmented into four major groups: physicians (including women’s care super-groups), physician office laboratories and national and regional laboratories. Both within and outside the United States, its customer specimens are sent directly to it, and it bills either through payer contracts or client bill arrangements. The company also offers access to its Ova1 and Overa assays via its decentralized technology transfer relationships established between it and authorized distributors. Commercial Operations The company has a commercial infrastructure, including sales and marketing and reimbursement expertise. The company also operates a national CLIA certified clinical laboratory, Aspira Labs. The company’s sales representatives work to identify opportunities for educating general gynecologists and gynecologic oncologists on the benefits of Ova1. The company holds CE marks for Ova1 and Overa. The company is targeting markets outside of the United States that it has Overa cleared on the Roche cobas platform, which is available globally. Aspira Women’s Health successfully launched a comarketing arrangement for Ova1Plus with BioReference Laboratories on October 5, 2022. Under terms of the agreement, the Aspira and BioReference sales teams will collaborate to sell Ova1Plus to gynecologists and other women’s healthcare providers nationwide. Intellectual Property Protection As of December 31, 2022, the company’s clinical diagnostics patent portfolio included 20 issued United States patents, 12 pending United States patent applications and numerous pending patent applications and issued patents outside the United States. Suppliers The company’s principal supplier is Roche Diagnostics Corporation. Strategy The company’s plan is to broaden its focus to the differential diagnoses of other gynecologic diseases that typically cannot be assessed through traditional non-invasive clinical procedures. The company expects to continue commercializing its existing and new technology and to distribute its tests through its decentralized technology transfer service platform, Aspira Synergy. The company also intends to continue to raise public awareness regarding the diagnostic superiority of Ova1 as compared to cancer antigen 125 (CA125) on its own for all women, but especially for racially diverse women with adnexal masses, as well as the superior performance of machine learning algorithms in detecting ovarian cancer in different racial and ethnic populations. The company plans to continue to expand access to its tests among Medicaid patients as part of its corporate mission to make the best care available to all women, and it plans to advocate for legislation and the adoption of its technology in professional society guidelines to provide broad access to its products and services. In 2022, the company has continued to grow Ova1Plus product volume and revenue through its commercial team. In addition, in October 2022, the company launched a co-marketing and distribution collaboration with BioReference Health, LLC, a subsidiary of OPKO Health, Inc. (BRL), as a new channel for volume growth. Also in the fourth quarter, the company announced that the American Medical Association assigned a new Proprietary Laboratory Assay code for OvaWatch, which will enable payers to identify OvaWatch specifically in the claims adjudication process beginning in April 2023. In addition, the Federal Omnibus bill passed by Congress in December 2022 mandates coverage for multi-marker testing for ovarian cancer, such as Ova1Plus and OvaWatch via a National Coverage Determination within 180 days of the bill’s effective date. The company intends to launch the second phase, which will be used for serial mass monitoring, in 2023. The company plans to accelerate the development of its endometriosis product portfolio by supplementing its internal development and validation program with its partnership with Harvard’s Dana-Farber Cancer Institute (DFCI), Brigham & Women’s Hospital (BWH), and Medical University of Lodz through a sponsored research agreement that it entered into in the third quarter of 2022. The company is committed to launching a first-generation non-invasive endometriosis diagnostic tool in the second half of 2023. Trademarks The company’s registered and unregistered trademarks and service marks include VERMILLION, ASPIRA WOMEN’S HEALTH, OVA1, OVERA, ASPIRA LABS, OVACALC, OVASUITE, ASPIRA GENETIX, OVA1PLUS, OVAWATCH, ENDOCHECK, OVAINHERIT, ASPIRA SYNERGY, OVA360, ASPIRA IVD, OVASUITE, and YOUR HEALTH, and OUR PASSION. Government Regulations As a manufacturer of in vitro diagnostics (IVDs), the company is subject to regulatory oversight by the Food and Drug Administration under provisions of the Federal Food, Drug, and Cosmetic Act (the FDC Act) and regulations thereunder. The company is required to register and list its products with the Food and Drug Administration and to comply with the Quality System Regulation (QSR). History Aspira Women's Health Inc. was founded in 1993. The company was incorporated in the state of Delaware in 1993.
