Collaboration Marries Good Start’s Proprietary Technology with Roche Diagnostics’ Commercial Expertise for Broad Market Reach
CAMBRIDGE, Mass., December 5, 2016 /PRNewswire/ – Good Start Genetics, an information solutions company delivering best-in-class genetics offerings to growing families, today announced that it has entered into a collaborative agreement with global healthcare leader Roche (SIX: RO, ROG; OTCQX: RHHBY) to sell Good Start’s carrier screening service for inherited genetic disorders. Under the agreement, Roche Diagnostics will offer Good Start Genetics’ GeneVuTM carrier screening test service in conjunction with its HarmonyTM non-invasive prenatal test (NIPT) service to obstetricians and general practitioners caring for pregnant women in the United States.
"We are excited to announce our collaboration with Roche Diagnostics to address the significant market need for prenatal carrier screening utilizing our proprietary next generation sequencing technology platform," said Jeffrey Luber, President and CEO of Good Start Genetics. "It is an honor to team up with a world-class organization like Roche as we address a significant unmet need. Offering GeneVu, our comprehensive and highly accurate carrier screening test service for inherited genetic disorders, with Roche’s Harmony NIPT service, which assesses the risk of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy, provides the 20,000+ OBGYNs in the United States with two best-in-class solutions for their expectant moms.”
As the nation's leading medical organization for women's health, the American College of Obstetricians and Gynecologists (ACOG) recommends that the more than 60 million women of reproductive age in the U.S. be offered genetic testing for cystic fibrosis (CF), while the American College of Medical Genetics and Genomics (ACMG) recommends screening for both CF and spinal muscular atrophy. The GeneVu test service offers screening for these inherited genetic conditions and others.
“The agreement with Good Start Genetics will enable Roche to offer a broader range of screening services to healthcare professionals who provide care for pregnant women and for parents involved in planning a family,” said Whitney Green, Senior Vice President, Commercial Operations for Roche Diagnostics. “Good Start’s GeneVu service is an innovative test that will complement our Harmony prenatal test service to allow prospective parents to confidently assess the risk of various genetic conditions in themselves and in the child.”
About the GeneVu Test
GeneVu is a menu of pre-pregnancy/prenatal screening test services that identify carriers of genetic disorders such as cystic fibrosis, providing critical information to inform couples planning to start a family. GeneVu is the product of years of development and rigorous peer-reviewed validation that detects many more diseasecausing mutations than traditional genotyping-based screening tests, regardless of patient ethnicity. With its suite of proprietary technologies, processes and algorithms, Good Start Genetics was the first company to harness the power of next-generation DNA sequencing (NGS) in the fertility clinic setting with highly accurate and actionable tests, like GeneVu, resulting in higher mutation detection rates and fewer missed carriers. As part of the patient experience, GeneVu is supported by 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.
The GeneVu test has not been cleared or approved for commercial distribution by the FDA. It is available in the U.S. as a laboratory-developed test.
About the Harmony Test
Developed by Ariosa Diagnostics, a CLIA-certified and CAP-accredited laboratory, the Harmony Prenatal Test is a non-invasive blood test for pregnant women that can be used as early as 10 weeks into pregnancy. By evaluating cell-free DNA found in the mother’s blood, the test measures a woman's risk of carrying a baby with a chromosomal condition such as Trisomy 13, 18 or 21 (Down syndrome). It has been validated with the largest clinical data set of any prenatal cell-free DNA test, making it the most broadly studied cell-free DNA test. The Harmony test is available in more than 100 countries and has been used to guide clinical care in over 850,000 pregnancies worldwide.
As with other lab-developed tests, the Harmony test has not been cleared or approved by the FDA and is not available for sale as an IVD in the US. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.
About Good Start Genetics
Good Start Genetics is an information solutions company delivering best-in-class genetics offerings to growing families. Using advanced clinical sequencing, proprietary methods and information tailored to the individual, the Company’s suite of offerings arms clinicians and patients with insightful and actionable information to promote successful pregnancies and help build healthy families. Its flagship genetic carrier screening service, GeneVu, is a comprehensive menu of highly-accurate tests for known and novel mutations that cause inherited genetic disorders, and its proprietary and advanced preimplantation genetic screening test, EmbryVu, based on technologies exclusively licensed from Johns Hopkins University School of Medicine, is helping a wider range of couples find their paths to pregnancy at significantly lower costs. Good Start Genetics complements these offerings with world class customer care and genetic counseling to help families stay well-informed and best prepare for tomorrow. For more information, please visit www.goodstartgenetics.com
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognized as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry eight years in a row by the Dow Jones Sustainability Indices.
The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2015 employed more than 91,700 people worldwide. In 2015, Roche invested CHF 9.3 billion in R&D and posted sales of CHF 48.1 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com or usdiagnostics.roche.com.