Research Supports Compassionate New Biopsy Approach
Kylon® Hooked-Fabric Biopsy Technology
Histologics LLC is proud to have developed Soft-ECC® endocervical curette, and the SoftBiopsy® exocervical gynecological biopsy device. Both devices employ a multipatented hooked fabric (Kylon®) that simultaneously biopsies with frictional raking/de-bonding of epithelium from stroma, and traps and stores the tissue for transport to the lab.
The Soft-ECC® and SoftBiopsy® were developed with the patient care experience in mind. The Soft-ECC® design is intended to fit into most endocervical canals and yield an abundant biopsy sample. The ECC procedure is usually performed to remove tissue from the endocervical canal for histological analysis during colposcopy or during the diagnostic work-up of abnormal peri-menopausal or menopausal bleeding. Unlike cytobrush sampling which is a cytologic screening modality, Soft-ECC curettage produces diagnostic histological samples.
The SoftBiospy® device removes abundant tissue from epithelial surfaces of the cervix. The tip of the device comprised of rows of hooked fabric which collect and store the biopsy specimen is snapped free from the handle, and placed in the fixative vial where they are processed in the laboratory. Cervical biopsies are most commonly performed by pressing the device head onto the area of interest on the outer visible part of the cervix using simple rotation or key-turning like motions during colposcopy after an abnormal screening test. Use of the SoftBiopsy® produces multiple, small to moderate histological samples that are removed frictionally, not incision, and are consistent with multiple small punch biopsy samples.
The Kylon® fabric employed in these gynecologic tissue sampling devices captures and retains the specimen for transport. These Kylon® tipped devices are dually registered for clearance for sale with the FDA as both biopsy devices (gynecological biopsy or curette) and as Tissue Collection and Transport Systems because once the tissue is captured in the fabric base and snapped free, its function is as a non-sterile specimen container. The containment aspect of the system has been research-proven to retain an abundant sample for analysis in the lab.