Meagan developed a tumor in her neck when she was just 17. An endocrinologist took a tissue sample from her thyroid using a long needle. The doctor explained the tumor could be benign or cancerous. This set the stage for a very anxious week.
Several days later she got a call from her physician who said the sample was inadequate — they would need to repeat the process. Unfortunately, more than 20% of the patients undergoing Fine Need Aspiration (FNA) biopsies need to have the procedure repeated.
It took weeks to reschedule. Meagan had to live with the tumor for over a month before she was told, “Meagan, you have cancer.” No one was happy with the diagnosis or the process.
Meagan had her thyroid removed and is doing fine now. She takes thyroid medication daily and enjoys a normal life. Please scroll down to Meagan’s quote, which captures the perspective of countless people who have undergone FNA procedures.
FNA (Fine Needle Aspiration) Procedure
FNA is a type of biopsy procedure that extracts a tissue sample from a tumor, which is then sent to Pathology for evaluation. FNA evaluations can help diagnose or rule out cancer. It is most commonly used for lumps in the thyroid, lungs, pancreas, breasts and lymph nodes. Depending on the tumor, up to 32% of FNAs must be repeated due to insufficient samples. Learn More.
“It was so difficult to live with the fear of cancer and so painful to get your tumor sampled only to wait for a week to hear that the results were not conclusive. I truly hated that I had to come back and get tested again. There has to be a better process.”
Thyroid Cancer Patient
ROSE Procedure (Rapid On-Site Evaluation)
The ROSE procedure evaluates the tissue sample acquired through FNA to quickly determine if a sufficient sample has been obtained. The sample is then sent to Pathology for evaluation. Depending on the tumor, ROSE can reduce repeat biopsy rates up to 70%. Learn More.
Challenges with ROSE
Lack of standards/inconsistencies
- Wide variance in protocols
- Disparity among quality of Cytotechnologists
- Sample drying can cause aerosolization, increasing risk of airborne disease
Disruptive and time consuming
- Cytopathologists and Cytotechnologists required to be on call
- Enormous time spent in OR rather than in lab
- High inflow of samples force Cytotechnologists to multi-task during FNAs
- Physicians extremely demanding
- Only 30% of institutions perform ROSE due to national shortage of Cytopathologists and Cytotechnologists
“The ROSE procedure has become the standard for FNA lung procedures and it is difficult to imagine that today it cannot be performed in every hospital in the country and even the world.”
David Wilson, MD
Based on feedback received to date from leading clinicians, we intend to address marketplace needs by rapidly delivering consistent, high-quality slides for ROSE procedures that are easier to read than conventional methods. Visit our Tech Platform page to learn more.