FDA Cleared Testing at CytoGenX

CytoGenX is committed to providing the most recent advances in FDA approved genetic technologies.

AneuVysion™ (FISH): In addition to our comprehensive panel of prenatal genetic tests, CytoGenX offers the only FDA-cleared prenatal genetic test available in the United States. The DNA-based STAT prenatal genetic test (AneuVysion™) answers urgent, important questions about a fetus. Using fetal cells obtained from amniotic fluid,

the test is a simple, quick and accurate way of determining if chromosomes 13, 18, 21, X and Y are present in their proper number. Together these conditions account for nearly two-thirds of all abnormalities identified at the time of amniocentesis, and 85-90% of clinically significant chromosomal abnormalities detected in live-born infants. At CytoGenX the results of this new FDA-cleared test are routinely issued in as little as 24 hours.

UroVysion™ (Bladder Cancer): CytoGenX is offering the first FDA approved gene-based test, UroVysion™ as an aid for initial diagnosis of bladder cancer in patients with Hematuria. UroVysion™ in combination with cystoscopy offers the best available combination of sensitivity and specificity in the detection of recurrent bladder cancer. This new test allows a physician and patient to now have a previously unavailable non-invasive option to accurately diagnose and manage bladder cancer recurrence.

Cystic Fibrosis: CytoGenX is now providing the new FDA approved expanded 60 mutation panel for cystic fibrosis carrier screening.  This test simultaneously screens for the 23 CFTR gene mutation/deletions recommended by ACOG/ACMG plus 37 additional mutation/deletions and 4 variants common in the ethnically diverse North American population.

PathVysion™ (HER-2/neu): CytoGenX is offering FDA approved  PathVysion™ testing which is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.The identification of HER-2 over expression by immunohistochemistry in conjunction with gene amplification detected by FISH is associated with a comprehensive positive response to the humanized, monoclonal antibody Herceptin® in patients that have failed standard chemotherapy treatment.  The detection of HER-2 gene amplification by FISH analysis is linked with rapid cancer cell proliferation, decreased disease-free survival and poor overall survival in both node-negative and node-positive ductal breast cancers.  In patients with advanced breast carcinoma, HER-2 amplification predicts responsiveness to transtuzumab (Herceptin®) therapy and poor response to standard chemotherapy.