New lab designed to significantly increase company's genetic testing volume while decreasing turnaround times with a continued focus on its already best-in-industry accuracy

ALISO VIEJO, Calif., Feb. 18, 2016 — (PRNewswire) —   Ambry Genetics (Ambry), a leader in clinical genetic diagnostics and genetics software solutions, today opened its Super Lab, one of the largest, most state-of-the-art laboratories featuring some of the most sophisticated equipment of any commercial or academic laboratory in the world.

At 65,000-square-feet, the new Super Lab is more than four times larger than Ambry's previous operations.  With the new lab, the company will initially triple the number of patient samples it currently processes on a daily basis, though the Super Lab is designed to increase the current capacity nine fold.  Importantly, the lab's fully-automated system allows technicians to start analyzing samples faster so that more samples can be processed with quicker turnaround times – meaning that physicians and genetic counselors have results faster, when every week matters for their patients.  Along with an increased volume and speed, the Super Lab will improve on Ambry's already best-in-industry accuracy through expanded quality control measures. 

"Ever since I started Ambry, I've been driven to make genetics a more empowered, collaborative science to fulfill the promise of the human genome and help people live healthier, better lives. We customized this lab to help us collect the wealth of genomic data and support the kind of research that will achieve this mission," said Charles Dunlop, Founder and CEO, Ambry Genetics.  "As a company, Ambry has always been committed to high-quality science, uncompromising accuracy, and industry-leading service, all to offer healthcare providers with the best information possible to help them make the most informed decisions about their patients' care.  The Super Lab is truly one of the best laboratories in the industry, with technologies that you won't find in other commercial or academic labs in the United States."

Since 1999, Ambry Genetics has made Orange County its home base, and remains committed to growing its operations in the area.  The company started in a small office above a motorcycle shop with one genetic test for cystic fibrosis.  Since then, Ambry has grown to be one of the premier, scientist-led laboratories in the world, employing more than 700 people and offering the most comprehensive suite of genetic testing solutions in the world, with strength in oncology, neurology, and cardiology.

"Aliso Viejo is known worldwide as a prominent technology and medical-device corporate and research-and-development hub," said Mayor Mike Munzing.  "To have one of the world's largest, most state-of-the-art commercial labs working to help people live better, healthier lives located in our city is incredible and certainly puts Aliso Viejo on the international stage."

Building One of the Most Advanced Laboratories
The Super Lab represents the next phase in Ambry's continuing growth and success. The following are some key highlights of the new facility:

• Fully automated: Every technology is automated to improve efficiency and reduce the risk of human error. For example, a custom-built conveyor belt system moves samples through each part of the testing process, photographing the sample and scanning the sample barcode along the way. Automation allows Ambry staff added time to conduct research that provides the medical community with new insights into potential genetic risks;

• Customized and flexibly designed: The Super Lab's Laboratory Information Management System (LIMS), which supports workflow and data tracking, was custom built specifically for the company's needs. The Super Lab's custom in-house design also allows for any upgrades or changes to be made to the facility without ever disrupting normal operation;

• Shorter turnaround times: Automation means testing analysis can begin faster so results can get in the hands of healthcare providers in less time. Ambry expects, for example, the turnaround times for one of its cancer panels to be about one to two weeks faster;

• Continued focused accuracy: Ambry's laboratory team has studied thousands of samples to determine the ideal balance between sensitivity and specificity in an effort to minimize the possibility of both false negatives and false positives. The company's bioinformatics pipeline allows for the lowest possible false positive rate without sacrificing sensitivity. Sanger sequencing (another method of DNA sequencing) is used to confirm the reported results and ensure they are correct;

• Increased quality control measures: Microarrays and next generation sequencing are run concurrently in the new lab to call out deletions and/or duplications. Every sample is DNA fingerprinted to avoid sample tracking issues throughout the workflow and an accuracy check on every sample;

• Improved testing integrity: Ambry installed separate DNA accessioning and isolation areas in the new lab, a practice that is not common in the industry but lowers the risk of sample contamination. Zero-vibration flooring throughout helps the building withstand seismic tremors so even a 747 aircraft could land on the second floor without shaking the equipment and causing errors to the results;

• Greater genomic insights: The new facility includes a variant assessment lab, which will support further investigation of genetic variants of unknown significance. The dedicated multidisciplinary team for variant interpretation includes M.D. and Ph.D. laboratory directors, biostatisticians/bioinformaticians, structural biologists, variant scientists, and genetic counselors, who work together to interpret clinical findings and support the publication and sharing of these data with the scientific community;

• Always operational: Ambry's laboratory is a 24/7 operation protected by one of the largest industrial generators, powerful enough to keep the entire facility running for ten days in the event of total power failure.

"The Ambry Super Lab was designed to include the best technologies in the industry, enabling us to provide healthcare providers with the fastest, most accurate results," said Aaron Elliott, Ph.D., Chief Operating Officer and Interim Chief Scientific Officer, Ambry Genetics.  "As a scientist, I am excited by the possibilities this lab offers in terms of improving our company's research capabilities and speeding up our ability to discover new genetic markers that may have significant implications for clinical practice."

An Experienced Laboratory with Many Firsts
Ambry's new Super Lab is built on the company's experience and history.  Since 2001, the company has performed hundreds of thousands of genetic tests and identified more than 45,000 mutations in over 500 different genes, including more than 100,000 next generation sequencing (NGS) panels.  Ambry was the first commercial lab to offer NGS and hereditary cancer NGS panels.  It also was the first lab to include BRCA1/2 on NGS.  In addition, Ambry was the first lab to offer clinical diagnostic exome sequencing, which looks at the functional part of the human genome and provides a wealth of information for essentially every human disease.

ABOUT AMBRY GENETICS®
Ambry Genetics is a privately-held healthcare information company with the most comprehensive suite of genetic testing solutions for inherited and non-inherited diseases.  Since 1999, Ambry has tested approximately half a million patient samples benefiting 90% of all U.S. patients covered by public and private insurers.  Ambry is both College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified.  The company leads in clinical genetic diagnostics and genetics software solutions, combining both to offer the most comprehensive testing menu in the industry. Ambry has established a reputation for sharing data while safeguarding patient privacy, unparalleled service, and responsibly applying new technologies to the clinical molecular diagnostics market. For more information about Ambry Genetics, visit www.ambrygen.com. 

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