CLN Article

Industry Playbook

Circulogene, University of Alabama Team to Validate Finger-Stick Liquid Biopsy

Circulogene Theranostics and the University of Alabama at Birmingham (UAB) are collaborating to validate a liquid biopsy developed by Circulogene for monitoring and managing cancer treatment. Circulogene’s test works by first enriching cell-free DNA (cfDNA) from a single blood drop, followed by next-generation sequencing to detect nearly 3,000 oncogenic mutations on 50 well-established genes associated with 10 cancer types, including breast, lung, and colon cancer. Clinical research that the company recently published shows that, from 20–50 µL of blood, its proprietary method collects 100 times more cfDNA than the current industry standard for non-invasive liquid biopsy testing.

Circulogene is now working with UAB scientists specializing in gynecologic, gastrointestinal, and urologic oncology to confirm these results and demonstrate the viability and applicability of its liquid biopsy service. The details of the studies that UAB is conducting are currently undisclosed, but the partnership aims to publish its findings as early as the first quarter of 2016. Circulogene’s CLIA-certified lab is also based in Birmingham and the company chose to team with UAB due to the university’s standing as one of the top 20 cancer centers in the U.S.

With these validation studies underway, Circulogene is currently offering its liquid biopsy to oncologists as a laboratory-developed test.

“Circulogene’s proprietary method could be more sensitive and more specific than other liquid biopsies, and could also be simpler and more convenient,” said Scott Rezek, Circulogene co-founder and chief operating officer. “This is important technology that could help known, diagnosed cancer patients right now, when doctors have exhausted the tumor tissue they can test or they can’t reach the tissue anymore. When this happens, the way to monitor tumors is through cell-free DNA.”

Quest to Take Charge of Lab Operations at Barnabas Health Hospitals

Quest Diagnostics and Barnabas Health, New Jersey’s largest not-for-profit integrated healthcare delivery system, have signed an agreement under which Quest will manage laboratory operations for all seven Barnabas Health Hospitals. This partnership aims to expand information connectivity options, reduce laboratory testing costs, and provide access to Quest’s IntelliTest Analytics utilization solution. “Leading hospitals are increasingly focusing on their core business and turning to Quest to help them evaluate and execute their lab strategy so they can do what they do best—deliver great patient care,” said Steve Rusckowski, president and CEO of Quest Diagnostics. “This partnership follows a model for delivering high-value diagnostic information services for our nation’s cost-pressured health systems.”

Vanderbilt University, Diatherix Join Forces to Advance Infectious Diseases Testing

Diatherix Laboratories, an independent, high complexity lab specializing in infectious diseases testing, has established a multi-year partnership with Vanderbilt University Medical Center (VUMC) and the Vanderbilt Vaccine Research Program. Under the terms of this collaboration, Diatherix will provide clinical laboratory services using its proprietary multiplex molecular diagnostic platform for the detection of infectious diseases. Through various research programs, the two organizations aim to enhance and expand their abilities to detect bacterial and viral infections in both pediatric and adult patient populations. “In the current climate of complex infections and antimicrobial resistance, securing a microbiologic diagnosis as quickly as possible is an important aspect of patient care,” said C. Buddy Creech, MD, MPH, a principal investigator at VUMC. “We are excited about the prospect of improving our ability to make rapid diagnosis in some of our most challenging patients, such as children with bone and joint infections, as well as those with infections of the central nervous system.”

LabCorp to Buy Women’s Health Lab

LabCorp has entered a definitive agreement to buy all of the operating assets of Pathology, Inc., including the patient centers used to conduct Pathology, Inc.’s medical testing and its services business. Pathology, Inc. is a full-service independent women’s health laboratory that provides expertise in reproductive donor testing, as well as general clinical laboratory testing and anatomic, molecular, and digital pathology services.

“Pathology, Inc. is a premier laboratory known for quality, science, and innovation in women’s health testing,” said David P. King, chairman and CEO of LabCorp. “It is an excellent fit with LabCorp’s existing women’s health service offerings and supports our mission to provide world class diagnostic solutions that improve health and improve lives.”

The terms of the agreement were not disclosed, but the transaction is expected to wrap up in the first quarter of 2016. Upon closing of the transaction, Pathology, Inc. will cease operations.

Illumina, Novogene Team on Prenatal and Oncology Tests for Chinese Market

Illumina and the Beijing-based company, Novogene, have joined forces to develop advanced clinical applications based on next-generation sequencing (NGS) technology, signaling the increasing importance of genomic applications to improving healthcare in China. The two companies expect to develop for the Chinese market a user-friendly diagnostic system for clinical prenatal DNA and oncology testing. To accomplish this, the partnership will leverage Novogene’s advanced clinical application development capabilities, including its nucleic acid extraction, library preparation, and data analysis software, while Illumina will provide NGS instrument components and related reagents.

“Novogene is pleased to partner with Illumina to advance the application of NGS technology in precision medicine,” said Ruiqiang Li, PhD, Novogene founder and CEO. “As the first company in China to purchase Illumina’s HiSeq X Ten System and the largest provider of Illumina-based sequencing capacity in China, Novogene welcomes this opportunity to improve the quality of care enjoyed by the Chinese people.”

Human Longevity Acquires Genome Informatics Company

Human Longevity, Inc. (HLI), the creator of an extensive database of whole genome, phenotype, and clinical data, has acquired the genome informatics company, Cypher Genomics. Cypher’s proprietary software, Mantis, provides comprehensive interpretation of genomic sequencing data, enabling customers to uncover clinically significant variants. The company has also developed Coral, a biomarker discovery service. Industry collaborators for these products include Celgene, Illumina, and Sequenom. Cypher also has a number of key academic partnerships with Scripps Translational Science Institute, University of Pennsylvania, and Clinic for Special Children.

“We developed Mantis and Coral to provide rapid, automated genome interpretation at a scale enabling disease gene identification, population-based studies, diagnostic development, and biomarker identification,” said Ashley Van Zeeland, PhD, Cypher’s CEO and co-founder who now heads Human Longevity’s pediatric business. “We look forward to joining the HLI team and to helping advance HLI's mission of applying the power of human genomics and informatics to improve healthcare."