ASP Health, a private medical device company focused on developing and commercializing innovative sample preparation technology to enhance and expand cancer diagnosis, successfully introduced its novel system at the American Society of Cytopathology (ASC) 69th Annual Scientific Meeting.
At the November 11-14, 2021 conference in Las Vegas, attendees learned how ASP Health’s FDA-registered automated sample preparation system can elevate the role of cytotechnologists during a Rapid On-Site Evaluation (ROSE) procedure. The ROSE procedure evaluates the tissue sample acquired through fine-needle aspiration (FNA) to quickly determine if a sufficient sample has been obtained for evaluation by the Cytopathology department.
FNA is a type of biopsy procedure that extracts a tissue sample from a tumor, most commonly in lung, breast, thyroid, pancreas, and lymph nodes. Unfortunately for medical teams and patients, it is common for FNAs to be repeated due to insufficient samples. Depending on the tumor, ROSE can reduce repeat biopsy rates up to 70%.
ASP Health President and CEO John W. Hart said, “It was exciting to launch and showcase our ASP System at the ASC meeting and receive such positive feedback from cytopathologists and cytotechnologists. Their responses confirmed our understanding that ROSE is growing in both use and importance despite the shortage of qualified clinicians. They also expressed their appreciation for our support in helping them improve the quality and efficiency of the ROSE process.
“The ASC meeting also provided the opportunity to discuss future collaborations with other attending companies developing remote-viewing microscopes and novel cell block capabilities intended to improve sample preparation for downstream cytological or molecular analysis.”
The ASP System is fast, efficient, and able to deliver consistent, high-quality samples that are equal to, or better than, those prepared manually. The instrument is lightweight and portable, so it can be placed on a cart and easily moved into operating theatres as needed, with a simple workflow requiring only minimal training to operate.
Three sites are performing clinical trials with the ASP System. Over the next three months, several renowned clinical sites will be enrolled in the study while others will participate in evaluating the units for purchase.
PLATFORM WILL HELP GUIDE PHYSICIANS’ DECISIONS ON CANCER TREATMENT OPTIONS
The ASP System is ROSE ready1 and is designed to help physicians develop treatment plans tailored to the needs of each patient. Working closely with our product development partner, Planet Innovation, extensive market research identified the need for the features that comprise the ASP System:
- a mobile, automated instrument with a simple and intuitive user interface,
- requisite consumables to reduce the risk of sample contamination,
- retention of remaining sample in a collection vial for future evaluation, and
- the ability to complete the entire process in under two minutes.
“It is more than frustrating to have to repeat an FNA. It is as if we have failed the patient,” said Kyle Hogarth, MD, FCCP, Interventional Pulmonologist, University of Chicago Medicine. “It keeps them in limbo until we can get a second surgery scheduled and results evaluated. The ROSE procedure gives us the best chance to avoid repeating FNA procedures.”
“What we need is an automated sample preparation system that can be brought into the operating room,” said Melissa Randolph, Cytopathology Laboratory Manager, Indiana University Health. “The ASP system offers this automation to the cytotechnologists while producing high-quality slides.”
For institutions that do not perform ROSE or have challenges in their current ROSE offering during fine-needle aspiration (FNA) procedures, The ASP System 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,
- an efficient process to ensure sample preparation does not prolong the physician’s FNA procedure and the patient’s time under anesthesia,
- consistency and 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; and
- sample custody of clinically important specimens separated into individual collection vials for future molecular/genetic testing to guide downstream patient therapy.
