Good Start Genetics® Announces The Expansion of its Next-Generation DNA Sequencing -Based Carrier Screening Service

SAN DIEGO and CAMBRIDGE, Mass., Oct. 22, 2012 /PRNewswire/ -- Good Start Genetics®, a leading and innovative molecular diagnostics company offering the new gold standard for genetic disease carrier screening, announced today that it has launched an expanded menu of testing services. The announcement, made at this week's annual meeting of the American Society for Reproductive Medicine (ASRM), means that Good Start Genetics' screening service, GoodStart Select™, now offers state-of-the-art testing for all 23 of the diseases recommended in guidelines set by the major medical societies, including the American Congress of Obstetricians & Gynecologists (ACOG), the American College of Medical Genetics and Genomics (ACMG) and societies supporting the Ashkenazi Jewish population. Good Start's screening services centers on the revolutionary, next- generation DNA sequencing platform - which can detect far more disease-causing mutations than the older, genotyping-based platform - with the goal of providing the highest carrier detection rates possible.

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In addition to its menu of pan-ethnic tests (e.g. cystic fibrosis, fragile X syndrome and spinal muscular atrophy), tests for hemoglobinopathies (sickle cell anemia, alpha thalassemia and beta thalassemia) and routine tests for the Ashkenazi Jewish population, Good Start now offers the following additional tests: dihydrolipoamide dehydrogenase deficiency, familial hyperinsulinism, glycogen storage disease type 1a, Joubert syndrome 2, maple syrup urine diseases type A/B, nemaline myopathy, Usher syndrome type 1F, Usher syndrome type III, and Walker-Warburg syndrome.

Good Start performs testing in its CAP- and CLIA-accredited, state-of-the-art laboratory facility located in Cambridge, MA, and has built a dedicated team of customer care specialists, genetic counselors and board certified medical geneticists to support patients and clinics. Good Start works closely with patients and their insurance providers to simplify the billing and payment process. In addition, as part of its mission to provide accurate, simple and responsible testing, Good Start has launched a new web site, which includes patient and physician-friendly tools that facilitate in the test selection process. (Good Start's test menu can be customized for each patient based on family history, patient ethnicity, or any other criteria the clinician deems important.)

"Reproductive healthcare professionals have long followed guideline recommendations for carrier screening for their patients planning pregnancy," said Michael Alper, M.D., Medical Director & Reproductive Endocrinologist, Boston IVF. "However, conventional screening methods have, to date, been limited by either their rigidity or the relatively small number of mutations that can be analyzed in a specific gene. Given recent advancements with the next-generation sequencing technology, we are pleased to be able to offer Good Start's technology to our patients in routine clinical practice."

"We are excited to make these additional tests available, and to meet the growing screening needs of new families and those wishing to start families," said Don Hardison, Good Start Genetics President and Chief Executive Officer. "And, using our next generation sequencing platform, we are already detecting mutations that other laboratories simply cannot. With this powerful technology, combined with our intense customer focus, we are confident we are delivering the best screening experience possible for patients and clinicians and, most importantly, critical information that can help increase a couple's chance of having a healthy baby. As a result, we expect that our sequencing-based approach to screening will continue to replace older, genotyping-based approaches and solidify our reputation as a leader in the carrier screening market."

Background
According to figures from the U.S. Human Genome Project, there are more than 6,000 known single-gene disorders, which in aggregate affect about 1 out of every 200 births.[1] National organizations, such as ACOG and ACMG, recommend that preconception and prenatal carrier screening be made available for couples for a numerous genetic disorders, so that healthcare providers and their patients can better understand the risks of the patient being a carrier of a genetic disorder, and, therefore, the risk of passing that gene or disease on to their offspring.

Routine genetic carrier screening has traditionally employed targeted mutation analysis technologies via 'genotyping' platforms, which, due to cost considerations, are designed to detect only a small number of the most common disease-causing mutations which are prevalent in only specific populations. The next-generation sequencing platform developed by Good Start Genetics, however, allows for a more comprehensive determination of carrier status in routine clinical practice because it is not limited to a small targeted mutation set and, therefore, can achieve high clinical sensitivities regardless of ethnicity.

About Good Start Genetics
Good Start Genetics is setting the new gold standard in carrier screening in routine clinical practice by making testing for the most comprehensive set of disease-causing mutations. After years of development and rigorous validation, Good Start Genetics has harnessed the power of next-generation sequencing and other best-in-class technologies to provide highly accurate, actionable, and affordable tests for all ACOG-and ACMG-recommended disorders. For these reasons, fertility specialists and their patients can have a high degree of confidence in their carrier screening results, and no longer have to compromise accuracy for price.  For online information about Good Start Genetics, please visit www.goodstartgenetics.com.

These tests were developed and their performance characteristics determined by Good Start Genetics®. They have not been cleared or approved by the U.S. Food and Drug Administration. However, the laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical testing and the tests have been analytically validated in accordance with CLIA standards. Good Start Genetics is both CLIA- and CAP-accredited.

[1] http://www.ornl.gov/sci/techresources/Human_Genome/medicine/assist.shtml

SOURCE Good Start Genetics