General Questions

  • What are the benefits of having my specimens tested at Gynecor?
    • Cytology and histology samples are simultaneously collected, insufficient sampling is minimized and among successful collections, we have cytology material to examine 100% of the time. Gynecor’s NuFix™ fixative preserves the three dimensional structure of cell aggregates, therefore similar criteria that are used for histology pattern diagnoses are applied to cytology “microbiopsy” diagnoses. When both histology and cytology are available, complementary information from both affords greater reliance on the final diagnosis. In addition, Gynecor delivers rapid results within 72 hours (3 working days) of the specimen being received in our laboratory. All reports can be accessed online at no additional charge through Webdox, and images are posted on abnormal (malignant and premalignant) diagnoses. Clients may call any of Gynecor’s expert pathologists for physician-to-physician consultations, and kits and UPS shipping are provided at no charge.

  • How is Gynecor’s NuFix fixative different from others?
    • Gynecor’s NuFix™ “all purpose” cell and tissue fixative preserves cells, cell aggregates and small tissue fragments, allowing the same criteria that are generally used for histology pattern diagnoses to be applied to cytology diagnoses. NuFix is a proprietary fixative blended by Gynecor under GMP conditions, and it allows fixation and dispersion of the entire sample once it has been collected (allowing for the creation of “representative” cytology and histology slides). It does not distort the architecture of the endometrial glands, endocervical glands, or cervical squamous mucosa.

  • Do I have to use the NuFix fixative for my biopsies?
    • Yes, NuFix™ allows Gynecor the capability to analyze both the histology and cytology components of the specimen. It also removes up to 0.25 ml (about 5 hanging drops) of blood per 15 mL vial. You can also use it for any and all biopsies done in the physician’s office (including LEEPs and small conization specimens) that then can be sent to Gynecor for processing. If you spill the fixative, do not use a different one. Instead, open another Gynecor kit and use one of its vials. Your Gynecor Pathology Sales Representative can provide your practice with extra vials at no charge. We can accept Pipelle®, LEEPs and Cones returned to us in formalin vials, however, we will able to report on histology only.

  • What is the cost for Gynecor’s test kits?
    • Because the brush collection portion must be returned to Gynecor for both cytology and histology testing, the testing kits, as well as the UPS shipping labels to return them to the lab, are all provided at no charge to the physician. Gynecor accepts all insurance plans (with a discount provided for self pay patients when requested).

  • Are Gynecor’s test kits FDA approved?
    • Both Gynecor’s Colposcopy and TruTest™ kits are made up of brushes and fixative. The two cytobrushes along with the fixative do not require 510K because they are Class I devices. The Tao® Brush in the TruTest kit is a Class II device which is FDA approved. The liquid-based method is an anatomical pathology process, which is not FDA regulated (so it cannot be FDA approved). An automated machine is considered a device and therefore requires FDA approval, while Gynecor’s method is manual so it does not. All components of Gynecor’s kits are compliant with FDA regulations and, as stressed above; manual processing does not require FDA approval.

  • Can the ECB cytobrushes provided in the kits detect glandular lesions?
    • Referring to Dr. John Maksem’s paper on ECC vs. ECB, often the brush was the only means by which endocervical adenocarcinoma in situ or glandular involvement by a high grade squamous intraepithelial lesion was detected. There are actually two cytobrushes in each Gynecor kit, both to be used and returned in the same vial of fixative. The first brush is meant to clear excess mucus from the endocervical canal. The second brush is meant to be used vigorously with a watch-winding motion in order to obtain epithelium and tissue microbiopsies from the endocervical canal.

  • What tests can be run off a Gynecor vial?
    • There are many, starting with our standards: cytology and cell block histology. Other add-on options currently include:

      • HPV genotyping by PCR
      • Chlamydia testing by PCR
      • N. gonorrhea testing by PCR
      • Genetic screening for Cystic Fibrosis by PCR
  • Why does Gynecor deliver both histology and cytology?
    • Histology depends on having enough tissue to yield an accurate test result. However, a tissue specimen is sometimes hard to collect, especially in post-menopausal patients. Gynecor’s NuFix™ fixative is multifunctional and can be used for both histology and cytology. Therefore, what is lost to one mode of examination may be detected by the other. For example, cytology outcomes may be available when histology results are not. Unlike other tests that may obtain insufficient tissue sampling, Gynecor's test results are not limited to histology only so they are successful more often with whatever specimen is collected.

  • What benefit does cytology add to histology?
    • Cytologies are very important because they add about 20% more information than is obtained with just the histology. Using this method, Gynecor has been able to diagnose ovarian carcinoma in transit, endometrial intraepithelial neoplasia and endometrial intraepithelial carcinoma. We believe that it would be a great disservice to the patient to not do cytology on the NuFix™ vials that we receive for testing. Since our fixative allows us to do this and to frequently correlate the finding with the histology, we get a much more reliable result.

  • Why use the cytobrushes when doing a colposcopy? Isn’t this a repeat of a Pap?
    • No! An endocervical (Cyto) brushing is not the same thing as a Pap smear. The endocervical brushing gives cytologic as well as histologic material (a cell block is made in most cases) and it serves the same function as the endocervical curettage, which is commonly done with colposcopy. (Diagnostic Cytopatholgy Vol. 34, No. 5, April 2006). The cytobrushes just offer a more comfortable collection for the patient.