Feasibility Data Presented at ASHG and ASRM Annual Meetings; Additional Data Highlight Clinical Value of GoodStart Select™ Versus Other Carrier Screening Technologies
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Good Start Genetics®, Inc., a commercial-stage molecular genetic information company, today announced that five abstracts were presented this week at the 2014 annual meetings of the American Society for Human Genetics (ASHG) and the American Society of Reproductive Medicine (ASRM). The abstracts showcase the broadening clinical application of Good Start’s next-generation DNA sequencing (NGS) technology and provide updated data demonstrating that the company’s NGS-based carrier screening tests more comprehensively evaluate carrier status, resulting in fewer missed carriers compared to other technologies.
“Next-generation sequencing is an extremely powerful tool, and it is exciting to present data that support clinical applications in reproductive medicine beyond carrier screening,” stated Don Hardison, president and chief executive officer of Good Start Genetics. “We look forward to continuing to expand the body of evidence in support of our carrier screening test, GoodStart Select™, and exploring additional ways our proprietary technology may provide actionable information to clinicians, patients and their partners prior to pregnancy.”
At both meetings, Good Start presented initial data supporting the feasibility of a new method to evaluate embryos for the correct number of chromosomes prior to implantation in an in vitro fertilization (IVF) setting. There is increasing evidence that this practice, known as preimplantation genetic screening (PGS), increases implantation and decreases miscarriage rates. However, widespread adoption of PGS has been limited in part due to the high cost associated with traditional approaches. The data presented by Good Start details an automated PCR-based method that can be used to infer copy number for each chromosome. Initial studies show accurate detection of abnormal chromosome copy numbers with high sensitivity and specificity. These initial results highlight the potential for Good Start’s method to be applied to PGS in the IVF setting.
At ASRM, Good Start also presented updated clinical data demonstrating that the company’s NGS platform detected significantly more mutations than common screening assays, specifically 63.1 percent of distinct disease causing mutations detected by NGS would have been missed with traditional screening. In a clinical setting (IVF centers across the U.S.), 2,309 pathogenic mutations among 15 genes were detected across 48,761 patients. Had traditional screening assays from six leading laboratories been used, 14-22 percent of all carriers identified would have been missed, increasing the risk of a reproductive couple conceiving a child with a debilitating or fatal genetic disorder.
About ASHG
The American Society for Human Genetics is the primary professional membership organization for human genetics specialists worldwide. The Society’s nearly 8,000 members include researchers, academicians, clinicians, laboratory practice professionals, genetic counselors, nurses and others who have a special interest in the field of human genetics. The 2014 ASHG Annual Meeting is attended by research scientists and health professionals from around the world who are dedicated to genetics research, education and support.
About ASRM
ASRM is a multidisciplinary organization dedicated to the advancement of the art, science and practice of reproductive medicine. The 2014 ASRM Annual Meeting is dedicated to transforming reproductive medicine worldwide and is attended by global thought-leaders and practitioners from the reproductive health community, including reproductive endocrinologists, embryologists and allied health professionals.
About GoodStart Select™
GoodStart Select is Good Start Genetics’ menu of genetic carrier screening tests that, for diseases such as cystic fibrosis, detects many more disease-causing mutations than traditional genotyping- based screening tests, regardless of patient ethnicity. The product of years of development and rigorous validation, GoodStart Select includes a suite of proprietary technologies, processes and algorithms designed to harness the power of next-generation DNA sequencing (NGS), to provide highly accurate and actionable tests resulting in higher mutation detection rates and fewer missed carriers.
To support its genetic carrier screening capabilities, Good Start Genetics has a dedicated team of customer care specialists and board certified genetic counselors who provide step-by-step support, from test selection through results, analysis and reporting. Good Start Genetics seeks to enable reproductive health specialists and their patients to have the highest degree of confidence in their genetic carrier screening results.
About Good Start Genetics, Inc.
Good Start Genetics is a commercial-stage molecular genetic information company focused on fundamentally transforming the standard of care in reproductive medicine by providing physicians and their patients with clinically relevant and actionable information concerning inherited genetic disorders. Good Start Genetics’ powerful, proprietary next-generation DNA sequencing (NGS) capabilities are supplemented by other proven genetic screening technologies and supported by its commitment to customer care and genetic counseling. Through GoodStart Select, the company provides a comprehensive and clinically actionable menu of genetic carrier screening tests for known and novel mutations that cause inherited genetic disorders. For more information, please visit www.goodstartgenetics.com.
Contacts
Pure Communications
Susan Heins, 864-346-8336
sjheins@purecommunicationsinc.com
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