How It’s Made – Lab Edition: An Overview of the Test Development Process at a Commercial Lab

As the understanding of human genetics expands and more genes are identified to be associated with various diseases, the demand for different types of genetic testing panels increases. But how do genetic testing laboratories decide which tests to offer and which genes to include? How are new tests developed, validated, and launched to healthcare providers and patients?  In this EducateNext session, the speakers will examine the process that one genetic testing laboratory follows to inform test menu decisions, as well as develop, validate, and launch new products to market.

Level of Instruction: Intermediate

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Jessica Profato
Sr. Manager, Product Management, Ambry Genetics
Jessica Profato is a Manager, Product Marketing at Ambry Genetics. She has been a member of the Ambry team since 2015. She is also a Genetic Counselor and earned her master’s degree in Genetic Counseling from Stanford University.

Jessica Profato is a Sr. Manager, Product Management at Ambry Genetics. In this role, she leads a team of product managers who are responsible for developing the product roadmaps across Ambry’s inherited disease menus for oncology, cardiology, neurology, and rare disease. She is passionate about delivering innovative and clinically meaningful genetic testing products to healthcare providers and their patients. Jessica is a Genetic Counselor by training. She received her Master’s in Genetic Counseling and Human Genetics from Stanford University in 2012. Prior to joining Ambry in November of 2015, Jessica was a clinical cancer genetic counselor at MD Anderson Cancer Center in Houston, TX, where she primarily focused on breast cancer and sarcoma patients.

Melissa Parra
Melissa Parra, MS, CGC
Director, Product Development, Ambry Genetics
Melissa Parra is driven by a passion for cross-functional execution and innovation, making her an ideal fit for her role as Vice President of Operations, PMO & Continuous Improvement at Ambry Genetics. In this position, Melissa leads the Continuous Improvement Office and Scaled Agile Delivery Group, transforming how Ambry delivers innovation. Since joining Ambry in […]

Melissa Parra, MS, CGC is the of Director, Product Development at Ambry Genetics.  She obtained her Bachelor of Science degree in Molecular Genetics from UC Davis and Master of Science degree in Genetic Counseling from California State University, Northridge.

Ms. Parra previously worked as a cytogenetics technologist at Cedars-Sinai Medical Center. She then worked as a prenatal genetic counselor at Cedars-Sinai Medical Center before taking a position at the Molecular Diagnostic Laboratory at City of Hope as a laboratory genetic counselor assisting in coordinating genetic testing and results interpretation for cancer genetics, genetic coagulopathies, neuromuscular conditions, connective tissue disorders, and intellectual disability.

Ms. Parra joined Ambry Genetics in 2010 overseeing the launch and reporting of Ambry’s first NextGen sequencing platform, a panel of 81 genes associated with X-linked intellectual disability.  In 2014 Ms. Parra began managing the reporting genetic counseling team and further focused on overseeing launches of new tests including EpilepsyNext, Neurodevelopment panels, and updates to Ambry’s Cardio and Cancer panels.  In 2015, Melissa moved into the role of Director of Product Development and has overseen the launches of products on Ambry’s testing menu, including Cancer, Cardio, Neurology, and RNAInsight offerings as well as oversite of the CARE patient screening platform.

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Kelly Burgess
Genomic Science Liaison, Ambry Genetics

Kelly Burgess is a certified genetic counselor and a Genomic Science Liaison with Ambry Genetics.  She earned an MS in genetic counseling from Wayne State University in 2014. She has been working with Ambry since February 2020 and provides clinical and technical support for hereditary cancer testing to providers across multiple states, including Illinois, Wisconsin, Minnesota, and the Dakotas. Prior to joining Ambry, she worked as a clinical cancer genetic counselor for 6 years with the bulk of her clinical time spent at Rush University Medical Center in Chicago, IL.