Current Platform
Our ASP System is ROSE ready* and is based on a series of innovations guided by extensive market research that identified the need for:
Value Proposition
For institutions that do not perform rapid on-site evaluation (ROSE) or have challenges in their current ROSE offering during FNA procedures, ASP Health’s technology platform offers:
Quality
samples that are equal to or better than current manual processes;
Automation
to reduce the pressure on cytotechnologists that prepare samples manually during a patient procedure;
Efficient Process
to ensure sample preparation does not prolong the physician’s FNA procedure and the patient’s time under anesthesia;
Consistency/
Standardization
to reduce the variability in sample preparation and to standardize protocols to enhance patient safety and workflow efficiency.
AI Compatibility
to enhance the evaluation and detection of cancer;
Sample Custody
of clinically important specimens separated into individual collection vials for future molecular/genetic testing to guide downstream patient therapy.
Ultimately, our platform will help guide physicians’ decisions on treatment options.
Key market research learnings from three cohorts:
Interventional Pulmonologists:
“ROSE is the new standard; we could use better and faster devices in our O.R.s and other settings to meet the demand for FNAs and shorten procedure times”
Cytopathologists:
“Producing consistent standardized samples quickly would reduce stress on our cytotechnologists”
Futurists:
“Consistent automated samples will lead to remote and automated reading of these specimen slides as well as expansion to other opportunities”
The current national shortage of cytopathologists and cytotechnologists, particularly in rural areas, significantly limits the number of institutions that can perform ROSE. Our automated technology provides a cost-effective solution to this problem, a solution that will help more people survive cancer.
Commercialization
Phased Rollout:
Our initial focus is on the successful development and pilot commercialization of the automated ROSE sample preparation system using ASP Health’s proprietary technology platform. Additional instruments and tools to enhance evaluations in the pathology lab will follow.
Intellectual Property:
ASP Health is establishing broad coverage of its intellectual property rights through design and utility patents for its instrument and disposables, and for future software applications. Currently, we have five patent applications and two provisional patents submitted.
Regulatory:
As a Class 1 device, our technology is already registered with the U.S. Food and Drug Administration (FDA) and its safety has been tested by Underwriters Laboratories (UL).
Partnership:
We intend to partner with a commercial company that has the reach to successfully implement ASP Health’s ROSE system nationwide and support the long-term mission of the company.
Reimbursement:
The ROSE procedure is already covered under existing codes; new coding for our platform is not needed.
*NOTE
ROSE is a laboratory test that must be performed in accordance with the mandates of CLIA. The scope of practice for a ROSE service is dependent on the needs of the individual health care environment and best determined by the physicians and health care providers in each unique practice setting. The ASP System may only be used with reagents that are indicated for use. Other reagents may be used for research purposes only and need to be independently validated by the users of the ASP System. Sites are responsible to follow the most current version of the CLIA regulations Part 493.