ASP Health is an early-stage medical device company focused on developing innovative automated solutions for Point of Care Cancer Diagnostics
Origin Story
ASP Health originated when the founding team was developing an easy-to-use, cost-effective, Point of Care cancer screening test.
Our team recognized that a better sample preparation method would enable automated reading of slides. With a clear problem in mind, we created a new method to produce high-quality monolayer slides.
Our “A Ha” moment came during discussions with external clinical experts. They felt our monolayer slides could significantly impact the pathology industry. They urged us to find partners to help us revolutionize the automation of pathology.
Through collaborations with pathologists nationwide, we created ASP Health to enhance cancer diagnostic techniques and improve patient outcomes.
Market Research
Extensive market research revealed a clear product white space in Point-of-Care Pathology.
One such procedure category is Rapid On-site Evaluation (read more about ROSE here), which involves a Point of Care procedure that provides immediate feedback to the physicians on the quality and adequacy of the specimen. Hence, ASP Health chose as a first indication to fully standardize and automate the ROSE process that is currently being done manually due to the lack of commercially available automated instruments.
Product Development
We partnered with Planet Innovation, a world-class company known for creating breakthrough products and commercially successful businesses. Its expertise in research, design, engineering, and early manufacturing helped us to develop ASP Prep™, an innovative automated sample preparation system designed for Point of Care applications, such as Rapid On-site Evaluation (ROSE).
ASP Prep™ underwent extensive clinical studies at leading institutions, such as Mayo Clinic, University of Chicago, Baylor Scott & White – Dallas, and First Health Regional Center in Pinehurst, NC. These studies helped us refine the ASP Prep™ instrument for our first indication, ROSE.
It is registered with the FDA as a Class I product, classified in the EU as Class A (non-sterile) with CE marking, and certified by UL as conforming to recognized industry safety standards.
Commercial Launch
Following completion of applicable regulatory registrations and certifications, we initiated a pilot launch of the ASP Prep™ system in the United States and Europe, a system designed for the preparation of cytologic specimens for examination, including use in point-of-care workflows such as Rapid On-site Evaluation (ROSE), which serves as our first indication of use.
ROSE is often performed in conjunction with a biopsy test or fine needle aspiration (FNA) at the point of care to determine if the sample is adequate for downstream evaluation.
After a successful pilot launch, the ASP Prep™ system is now commercially available. We are excited to help those clinical sites that have not been able to offer ROSE or have significant challenges in their ROSE practice.
Product Expansion
After our successful pilot launch of the ASP Prep™ system, stakeholders explained how an end-to-end automated solution would provide additional value. This guidance led to our development of two additional innovations:
ASP View™, a fully automated light microscope enables remote viewing and control by a qualified cytopathologist or pathologist for real-time examination of specimen slides. Remote access supports point-of-care pathology workflows by enabling professional review outside the procedure suite, which may improve efficiency.
ASP Assist™, proprietary AI-based remote pathology software integrates with ASP View™ to identify cells of interest in real time to enable quick, accurate, remote adequacy assessment of specimen slides. Utilize AI- and algorithm-driven features for morphologic classification, image analysis, or specimen-content characterization. Note: ASP Assist is intended for Research Use Only until FDA clearance or authorization is obtained.
ASP Health’s End-to-End Solution for ROSE
Our Vision
ASP Health will provide an enriched point of care pathology experience for patients, physicians, and cytotechnologists to enhance cancer diagnosis and therapeutic evaluation, leading to improved patient outcomes.
Contact ASP Health
Please reach us at: 877-5ASPHEALTH (877-527-7432) or by email at info@asp-health.com
ASP Health operates under a Quality Management System certified to ISO 13485:2016 and EN ISO 13485:2016, with a scope covering the design and development of instruments used for sample preparation for in vitro diagnostic applications, including optical instruments used for microscopic examination of tissue samples in support of pathology and cytology applications.