FISH Technologies

Fluorescence in situ Hybridization (FISH) Technologies

TMD has extensive experience performing EGFR and HER2 FISH assays in support of clinical trials in a GLP laboratory setting. TMD has the capabilities to develop and validate custom FISH assays using DNA FISH probes that are commercially available from Vysis (http://www.vysis.com). FISH tests of current interest to TMD are for Akt, Met, PTEN, and BCR-ABL.

Detecting Gene Amplification or Deletion in Cancers
Many cancers feature amplification or deletion of certain genes related to cell growth and proliferation. Detection of gene amplification or deletion using FISH technology is useful for predicting patient response to certain targeted therapeutic agents. For example, HER2/neu amplification in breast cancer patients is correlated with response to the HER2-targeted antibody Herceptin. Similarly, deletion of the tumor suppressor gene PTEN has been associated with resistance to Herceptin therapy.

FISH Capacity
TMD uses commercially available FISH assays that are highly validated or even FDA approved. Our experience includes FISH prescreening for a recently published phase II trial in patients with breast cancer (Abstract #502, 2006 ASCO Annual Meeting).  Although FISH assays are frequently difficult to scale up, TMD’s scientists have been successful in developing protocols which can process up to 40 specimens per day. This allowed TMD to complete a retrospective EGFR FISH analysis of a large Phase III trial in a little over 3 weeks.

FISH Protocol Development
One critical aspect of insuring superior FISH data is customizing the assay to fit the type of tissue specimen to be processed. A number of factors, such as tissue type, specimen age and type of fixation can negatively impact the robustness of the FISH assay. TMD’s scientific team has proven expertise in customizing FISH assays for large clinical trials. Before proceeding with high throughput processing of FISH samples, TMD determines the optimal assay conditions in a pilot study to insure quality results.

The images on the left show breast cancer specimens probed for ErbB1 signals (orange) and chromosome 7 signals (green). (A) ErbB1 non-amplified specimen and (B) ErbB1 amplified specimen. The images on the right show breast cancer specimens probed for ErbB2 signals (orange) and chromosome 17 signals (green). (C) ErbB2 non-amplified specimen and (D) ErbB2 amplified specimen.

Key Benefits

To learn more, review TMD’s Breakthrough Article on FISH.

To order FISH assays, download a requisition or contact TMD’s Translational Biomarker Specialists at 866.897.7350 ex 213 or email TMD Translational Biomarker Services at biomarkers@tmdlab.com.