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CytoGenX Corp. Announces the Release of Assure™

CytoGenX Corp. Announces the Release of Assure™ Whole-Genome Microarray

CytoGenX Corp, a leading provider of medical genetic testing services, announced today it will be offering Assure™, its new comprehensive whole-genome microarray designed to aid in the detection and identification of disease-causing genetic alterations involved in prenatal and pediatric genetic diseases as well as cancer and infertility.

CytoGenX Corp, a leading provider of medical genetic testing services, announced today it will be offering Assure™, its new comprehensive whole-genome microarray designed to aid in the detection and identification of disease-causing genetic alterations involved in prenatal and pediatric genetic diseases as well as cancer and infertility. “Assure™, is an unprecedented diagnostic-tool capable of analyzing every gene in the human genome and will serve to advance the diagnosis and treatment of countless known and unknown human diseases,” said Joseph A. Gebbia, Ph.D., founder and CEO of CytoGenX Corp.

December, 2013-The American College of Obstetrics and Gynecologists (ACOG) issued new guidelines for the utilization of chromosomal microarray (CMA) in prenatal diagnostic testing. According to these guidelines CMAshould be offered to all patients undergoing an amniocentesis or CVS and should not be restricted to women age 35 and older.

The American College of Medical Genetics (ACMG) issued revised guidelines supporting the utilization of cytogenomic microarray analysis as “first-tier” diagnostic testing for both postnatal and prenatal samples (September, 2013) and for complementing the diagnosis of neoplastic disorders (April, 2013).

The Assure™platform, offered by CytoGenX Corp., will have a profound effect on the ability to provide state of the art genetic technology to patients. Assure™ SNP array can detect complex genomic changes not apparent by either karyotype or FISH and has applications for prenatal, postnatal and oncology.CMA technology provides higher resolution than karyotyping and therefore allows genome wide screening for microdeletions and microduplications. Submicroscopic rearrangements account for as much as 15% of human genetic disease.

Assure™ whole-genome SNP microarray provided, by CytoGenX,targets the entire genome utilizing 2.67 million markers for copy number analysis, 750,000 SNP markers and 1.9 million non-polymorphic probes. The platform offers excellent performance and exceeds current guidelines for specificity and resolution across the entire genome. The high probe density provides comprehensive coverage with 100% Sanger cancer gene coverage, 100% ICCG (formerly ISCA) constitutional gene coverage, 12,000 OMIN and36,000RefSeq genes on a single array. The presence of single-nucleotide polymorphism (SNP) markers enables high-solution copy number analysis to detect gains and losses in DNA,loss of heterozygosity (LOH), regions identical-by-descent, uniparental disomy (UPD)and mosaicism.

About CytoGenX:

CytoGenX provides the most innovative genetic technology available for the diagnosis of complex pregnancy, infertility, cancer and genetic disease. As an international provider of advanced medical genetic services, CytoGenX is committed to providing a multidisciplinary approach in the management of genetic disease.The focus of our highly specialized team of professionals is to empower clinicians and patients with an understanding of genetic disease and risk that allows for the most informed decision-making possible. CytoGenX strives toincrease the quality and longevity of human life through genetic testing. Since our inception, CytoGenX has continuously offered the most recent advances in clinically relevant technologies in medical genetics.

Company Contact:
Joseph A. Gebbia, Ph.D.
Founder & CEO, CytoGenX Corp.
(631)751-0212
Genetics@CytoGenX.com
www.cytogenx.com

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.