CYNOGEN: Founded by Abbott, a leader in molecular diagnostics, including companion diagnostics

 

CYNOGEN is a CLIA-certified molecular laboratory serving clients across the United States.

 

We offer assays that have been the subject of large clinical trials. Increasingly, companion diagnostics is a focus of our laboratory. For example, Vysis ALK, manufactured by Abbott Molecular, is the only FDA-approved ALK companion diagnostic validated in clinical trials for the ALK-directed therapeutic drug XALKORI® used for a specific portion of the non-small cell lung cancer patient population. In addition, CYNOGEN runs the FISH-based UroVysion test, also manufactured by Abbott Molecular and the only FDA-approved molecular test for bladder cancer. As additional diagnostics become available from Abbott Molecular to support personalized medicine, our goal is to make these available from CYNOGEN.

 

Through our testing, we strive to aid physicians in their goal to diagnose and monitor their patients. CYNOGEN provides information that can assist physicians in the application of targeted therapies for patients with cancer.

 

 

VYSIS ALK

Intended Use

The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).

The test is for prescription use only.

 

Limitations of the Procedure

  • FOR IN VITRO DIAGNOSTIC USE ONLY.
  • Optimal performance of this test requires appropriate specimen handling, preparation, and storage as described in the instructions for use.
  • The Vysis ALK Break Apart FISH Probe Kit has been optimized only for identifying and quantifying rearrangements of the ALK gene from formalin-fixed, paraffin-embedded human NSCLC tissue specimens. The assay should be performed only on 10% neutral buffered formalin FFPE human lung cancer tissue. Other types of specimens or fixatives should not be used.
  • The performance of the Vysis ALK Break Apart FISH Probe Kit was established using the procedures provided in the assay package insert only. Modifications to the procedures may alter the performance of the assay.
  • The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
  • Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green, and yellow signals.

 

Caution

United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.

 

XALKORI® is a registered trademark of Pfizer Inc.

FOR IN VITRO DIAGNOSTIC USE ONLY

 

 

UROVYSION

Intended Use: The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the UroVysion Kit are intended for use in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

 

Warnings and Limitations

  1. The UroVysion Kit has been optimized for identifying and quantitating chromosomes 3, 7, and 17, and locus 9p21 in human urine specimens.
  2. The performance of the UroVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
  3. The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  4. UroVysion assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate, e.g., the presence of excessive granulocytes or massive bacteruria.
  5. Technologists performing the UroVysion signal enumeration must be capable of visually distinguishing between the red and green signals.
  6. Positive UroVysion results in the absence of other signs or symptoms of bladder cancer recurrence may be evidence of other urinary tract related cancers, e.g., ureter, urethra, renal, and/or prostate in males, and further patient follow-up is justified. In a study conducted on patients with hematuria, 3 patients whose initial bladder cystoscopy was negative, were subsequently diagnosed with renal cancer within 6 months of this initial study visit. All 3 of these cases were positive by UroVysion.
  7. If UroVysion results are negative but standard clinical or diagnostic tests (e.g., cytology, cystoscopy) are positive, the standard procedures take precedence over the UroVysion test. Although the UroVysion Kit was designed to detect genetic changes associated with most bladder cancers, there will be some bladder cancers whose genetic changes cannot be detected by the UroVysion test.
  8. Ta stage solitary tumors smaller than 5mm could not be detected by UroVysion FISH. UroVysion FISH results are dependent on the amount of tumor cells that are deposited on the slide.

 

Caution:  United States Federal law restricts this device to sale and distribution to, or on the order of, a physician or a clinical laboratory; use is restricted to, by, or on the order of a physician.

 

FOR IN VITRO DIAGNOSTIC USE ONLY

 

Complete Package Insert for Vysis ALK Break Apart FISH Probe Kit

 

Complete Package Insert for the UroVysion® Bladder Cancer Kit