CLN Article

Industry Playbook

Organizations Partner on Effort to Tailor Initial Breast Cancer Treatments

Paradigm and TME Research have entered a collaboration to create a precision medicine breast cancer registry known as the Paradigm Neoadjuvant Breast Registry. Using Paradigm’s PCDx next-generation sequencing (NGS) test and other advanced molecular capabilities, the project will genomically profile invasive breast cancer in patients undergoing neoadjuvant (pre-surgical) or hormone therapy. PCDx is a comprehensive clinical-grade NGS-based test that identifies the underlying genomic and proteomic alterations of a tumor’s DNA, RNA, and protein. The test interrogates the most relevant genomic targets at over 5,000x average depth of coverage with 67 therapeutic associations. With the information it provides on the individual gene variability driving disease, Paradigm and TME Research envision that caregivers will be able to target neoadjuvant therapies and refine treatment selection to improve patient outcomes.

“While these new molecular tests are more commonly used to inform treatment selection when treating aggressive, rare, or refractory disease, they are also becoming increasingly valuable in earlier breast cancer treatment selection and management,” said Peter Beitsch, MD, co-principal investigator of this initiative at TME Research.

The initial 6-month pilot for this project will enroll 100 patients across eight primary U.S. centers, and will potentially expand in the future to 1,000 patients across 50 U.S. centers.

Lockheed Martin Creates Healthcare Technology Alliance

Lockheed Martin has forged a new healthcare technology alliance that combines the expertise of leading health IT providers, medical technology companies, and academic institutions to advance public health. The alliance’s founding members include Cisco, Cloudera, Illumina, Intel, and Montgomery College. Under the terms of the collaboration, they will develop technology solutions that help improve care in rapidly evolving and growing areas of health technology, such as those that secure patient medical information, leverage advances in genomic research, and apply big data solutions to improve public health.

Alliance partners are already making progress on complex health information technology solutions. In particular, Lockheed Martin and Illumina are currently working on tailored solutions for national-scale genomics programs.

“Federal health IT is a dynamic and growing sector,” said Horace Blackman, vice president of Health and Life Sciences at Lockheed Martin. “Through collaboration between health IT industry and academic partners, this team will develop and refine technologies that will help guide decisions for care, diagnosis, and treatment of disease while protecting critical health information.”

Roche to Buy Enzyme Engineering Company

Roche has signed a definitive agreement to acquire Kapa Biosystems, a provider of genomic tools in the life sciences sector that employs proprietary technologies to optimize enzymes for next-generation sequencing (NGS), as well as PCR and real-time PCR applications. Kapa’s proprietary protein engineering technology is highly customizable, enabling the generation and screening of large numbers of enzyme variants and the rapid selection of custom-made enzymes.

The company’s portfolio of NGS reagents includes enzymes such as novel DNA polymerases that have the potential to improve the performance of the entire sequencing workflow. “Kapa’s technology and products complement our current expertise and offerings such as the portfolio of target enrichment products for NGS,” said Roland Diggelmann, chief operating officer of Roche Diagnostics. “This acquisition builds on Roche’s commitment to develop a differentiated NGS portfolio that will provide our customers with a complete genetic testing solution.”

Illumina, Burning Rock Team on Oncology Molecular Diagnostics in China

Illumina has formed a partnership with Burning Rock, a diagnostics company headquartered in Guanzhou, China, under the terms of which Burning Rock will develop advanced clinical applications for molecular diagnostics in oncology based on Illumina’s next-generation sequencing (NGS) technology. In particular, the two companies will work together to develop a user-friendly, oncology molecular diagnostic kit for the Chinese market. As part of their agreement, Burning Rock will provide its nucleic acid extraction, library preparation, and data analysis software, while Illumina will provide NGS instrument components and related reagents.

This collaboration highlights the increasing importance of genomics to improve healthcare in China. “We have been working to promote the clinical application of genomic technology in China. Oncology molecular diagnosis based on NGS, including non-invasive testing, is being applied in the clinic and we hope to promote it as a standard practice in hospitals,” said Yusheng Han, the founder and CEO of Burning Rock. “Cooperation between our two companies will provide additional high quality molecular diagnostic solutions in the clinical field of oncology.”

Berg, U Miami Collaborate to Find Heart Disease Biomarkers

Berg and the University of Miami Leonard M. Miller School of Medicine are extending a pre-existing partnership to search for biomarkers for the early detection of cardiac dysfunction and heart failure. The University of Miami will provide Berg with access to clinical tissue samples obtained with patients’ consent from the Miller School of Medicine. These samples are representative of South Florida’s diverse population, and are comprised of healthy and diseased cohorts. Berg will then use its artificial intelligence platform, Interrogative Biology, to analyze the tissues in an effort to uncover novel biomarkers of heart disease.

The two organizations hope that these efforts will enable stratification of patients based on disease onset and progression, and facilitate timely clinical intervention to improve patient outcomes. Previously, Berg’s Interrogative Biology platform has also produced clinical and diagnostic assets, as well as biomarkers, in oncology and metabolic diseases.

SeraCare, UCSF to Develop Reference Materials for NIPT

SeraCare Life Sciences has signed a licensing deal with the University of California, San Francisco for trisomy 13, 18, and 21 trophoblast cell line material. SeraCare will use this material to create what could become the first patient-like reference materials for non-invasive prenatal testing (NIPT) of chromosomal abnormalities. As the market for NIPT continues to grow and more labs begin offering these services, there is a need for reliable reference materials to ensure the accuracy of results. This is especially critical as labs scale up their operations and need to train, validate, optimize, and monitor ongoing performance of their next-generation sequencing or microarray assays.

SeraCare will also seek early access partnerships with potential users of these reference materials so that labs can both evaluate and refine them to meet their specific requirements.