Welcome to our dedicated page for Aspira Womens Health news (Ticker: AWH), a resource for investors and traders seeking the latest updates and insights on Aspira Womens Health stock.
Comprehensive Overview
Aspira Womens Health Inc (AWH) is a bio-analytical company dedicated to the development and commercialization of noninvasive, AI-powered diagnostic tests that aid in the detection and assessment of gynecologic diseases. Integrating advanced biomarker technology with proprietary algorithms, the company addresses critical unmet needs in the realm of ovarian cancer risk and other serious gynecologic conditions. With a portfolio of blood tests marketed under the OvaSuite name, Aspira offers clinicians diagnostic tools such as OvaWatch and Ova1Plus, each designed to enhance diagnostic accuracy while reducing unnecessary surgical interventions.
Innovative Diagnostic Solutions
The diagnostic tests developed by Aspira are based on the principles of precision medicine, combining protein markers, microRNA, and patient clinical data to generate risk assessments for ovarian malignancy. AI-powered algorithms and sophisticated data analytics form the backbone of these tests, ensuring high negative predictive values and clinical reliability in routine gynecologic evaluations.
Core Product Portfolio
Aspira’s product range is built around the need to improve diagnostic accuracy in women presenting with adnexal masses. The company’s core solutions include:
- OvaWatch: A noninvasive blood test designed to assess ovarian cancer risk in patients deemed to have indeterminate or benign masses upon initial clinical evaluation, significantly enhancing the clinician's ability to monitor disease progression without immediate surgical intervention.
- Ova1Plus: A reflex testing portfolio that combines two FDA-cleared in vitro diagnostic tests, offering clinicians a robust toolset to further evaluate malignancy risk and plan appropriate patient management prior to surgery.
Clinical Impact and Market Significance
The comprehensive offerings of Aspira are positioned to make a meaningful impact on women’s health management. By providing a refined risk stratification process, the company ensures that patients receive appropriately tailored care. The noninvasive nature of these diagnostics reduces the dependency on surgical procedures, thereby lowering patient risk and associated healthcare costs. Aspira’s tests support a more conservative yet informed clinical decision-making process, ensuring that interventions are reserved for those with a genuine need for surgical evaluation.
Operational Excellence and Strategic Collaborations
Operational efficiency is at the heart of Aspira’s business model. The company has built a mature commercial infrastructure supported by strategic collaborations with clinical laboratories and healthcare providers. Its focus on integrating diagnostic testing with electronic medical records (EMR) systems enhances the delivery and accessibility of test results, thereby advancing the standard of care. Furthermore, Aspira leverages ongoing partnerships with scientific collaborators and healthcare organizations to continuously refine its diagnostic algorithms and expand its product portfolio.
Technological Edge and Expertise
At the core of Aspira’s success are its innovative, technology-driven approaches. The company employs AI and machine learning techniques to analyze a complex array of biomarkers, ensuring high sensitivity and specificity in the detection of ovarian cancer. This technical expertise is complemented by robust clinical validation, which has positioned its tests as integral tools in the diagnostic landscape of women’s health. By harnessing the power of data and evolving diagnostic technologies, Aspira exemplifies a scientific rigor that is essential for advancing modern healthcare.
Industry Position and Value Proposition
Within the competitive field of diagnostic testing, Aspira distinguishes itself through its focused approach on gynecologic diseases and its exclusive reliance on noninvasive testing methodologies. The company’s value proposition is strongly anchored in its ability to offer clinicians a reliable, rapid, and non-surgical diagnostic alternative for assessing ovarian malignancy risk. This solid scientific foundation, together with its AI-powered innovations, reinforces Aspira’s authoritative stance in the diagnostics domain, ensuring its continued relevance in an ever-evolving market.
Frequently Asked Questions
Below are some common queries addressed by Aspira’s comprehensive approach to diagnostic testing in women’s health, providing insights into its operational and scientific methodologies.
Aspira Women's Health has expanded its co-marketing and distribution collaboration with BioReference to include OvaWatch® in their portfolio. The partnership, which has included Ova1Plus® since 2022, will now market Aspira's complete OvaSuite portfolio to BioReference's healthcare provider clients. This expansion follows OvaWatch's approval by the New York State Department of Health's Clinical Laboratory Evaluation Program, making it available to over 15 million women in New York and New Jersey.
Aspira Women's Health (Nasdaq: AWH) has scheduled its Q3 2024 earnings release for Thursday, November 14, 2024. The company will discuss financial results for the three and nine months ended September 30, 2024. Management will host a conference call at 8:30 am ET to present financial results and provide a corporate update. The call will be accessible via toll-free number (877-545-0320) and international number (973-528-0002) with access code 436613. A webcast replay will be available on the company's Investor Relations website.
Aspira Women's Health (Nasdaq: AWH) announced it has been awarded $10 million over two years from the Advanced Research Projects Agency for Health (ARPA-H) as part of the Sprint for Women's Health initiative. The funding will support the development of ENDOinform™, a multi-marker blood test for endometriosis detection using AI-enabled algorithms combining protein and microRNA biomarkers. Selected as one of 23 awardees from over 1,700 submissions, Aspira received one of only six Launchpad awards for advanced-stage projects. The company expects to meet its first milestone in Q4 2024, triggering a $2 million payment. The company will host a virtual R&D Day on October 29, 2024, to discuss the development pipeline.
Aspira Women's Health (Nasdaq: AWH) has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program. The funding, distributed over two years through milestone-based payments, will support the development of EndoMDx, a multi-marker miRNA blood test for endometriosis detection. Selected from over 1,700 submissions, Aspira will collaborate with ARPA-H Program Manager and Investor Catalyst Hub for test development and commercial launch. The project addresses a critical need, as endometriosis affects up to six million women in the US, currently requiring invasive laparoscopic surgery for diagnosis, with patients typically facing 7-10 years delay in diagnosis.
Aspira Women's Health Inc. (Nasdaq: AWH) has received approval from the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for OvaWatch®. This non-invasive blood test assesses ovarian cancer risk in women with adnexal masses initially determined as indeterminate or benign. The CLEP approval, required for all lab-developed tests in New York, ensures compliance with state regulatory standards and includes a comprehensive review of Quality Management Systems.
CEO Nicole Sandford highlighted the significance of this approval, stating it opens doors to one of the nation's largest healthcare markets with over 10 million women in New York state. The CLEP approval is viewed as a validation of the test's rigorous science, potentially strengthening Aspira's credibility in other markets and positioning the company well for future regulatory pathways.
Aspira Women's Health (Nasdaq: AWH) has published data in Gynecologic Oncology demonstrating improved performance of its in-development blood test for assessing malignancy risk in adnexal masses. The study shows that combining miRNA with protein biomarkers, age, and menopausal status offers the most accurate classification for identifying early-stage ovarian cancer.
Key findings include:
- 92% sensitivity at 80% specificity overall
- 80% sensitivity for early-stage cancers
- 100% sensitivity for later-stage cancers
- 78% sensitivity for early-stage, serous ovarian cancers
- 82% sensitivity for early-stage, non-serous cancers
The combined model improved ROC AUC on internal (0.9) and external (0.95) validation sets compared to miRNA alone or proteins plus metadata without miRNA.
Aspira Women's Health (Nasdaq: AWH), a bio-analytical women's health company, announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel. CEO Nicole Sandford will deliver a presentation, available on-demand from September 9 at 7:00 am ET for registered attendees.
Company management will be available for in-person one-on-one meetings on September 10 and 11. Interested investors should contact H.C. Wainwright representatives. A replay of the presentation will be posted on the Events page of Aspira's Investors section on their website when available.
Aspira Women's Health Inc. (Nasdaq: AWH) has been selected as a spoke for the Investor Catalyst Hub, a regional hub of ARPANET-H, a nationwide health innovation network launched by the Advanced Research Projects Agency for Health (ARPA-H). This designation acknowledges Aspira's position as an innovator in women's health and provides new opportunities for funding, thought leadership, and networking.
The Investor Catalyst Hub, based in the Greater Boston area and managed by VentureWell, aims to accelerate the commercialization of groundbreaking biomedical solutions. As a spoke, Aspira gains access to potential funding, flexible contracting, and opportunities to provide input on ARPA-H challenge areas and priorities. The company joins a diverse network of organizations aligned with ARPA-H's mission to improve health outcomes through research focus areas such as health science futures, proactive health, scalable solutions, and resilient systems.
Aspira Women's Health Inc. (Nasdaq: AWH) has partnered with Dorsata, a healthcare software company, to develop a protocol workflow tool for the clinical treatment of adnexal masses. This custom care module will be integrated into Dorsata's electronic medical records (EMR) tool, which is used at over 300 clinical sites serving 2,500 clinical users. The module aims to improve the quality and consistency of patient care for women with adnexal masses and is expected to aggregate clinical data from a nationwide network of providers and patients.
Development of the module will begin immediately, with the goal of having the first provider contracted in Q4 2024 and completing all iterative design activities in Q1 2025. This collaboration is expected to help physicians more effectively identify patients who may benefit from innovative tools like biomarker blood tests.
Aspira Women's Health Inc. (Nasdaq: AWH) reported its Q2 2024 financial results. Key highlights include:
- OvaSuiteSM revenue of $2.4 million with 6,471 units sold
- Cash utilization decreased by 16% compared to Q1 2024
- Full year 2024 cash guidance reduced to $13-$14.5 million
- OvaWatch product volume grew 48% year-over-year
- Expanded addressable market to 2-4 million tests per year
- Gross profit margin of 59%
- Raised $4 million through private placement and warrant exercise
- Appointed John Kallassy as interim CFO
The company focuses on developing gynecologic disease diagnostic tools and aims to make OvaSuite the standard of care for adnexal mass diagnosis.
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