In This Issue...

UCSF, Quest Alliance Aims to Advance Precision Medicine
Quest Diagnostics and the University of California, San Francisco (UCSF) have joined forces to translate precision medicine research into clinical diagnostics. With an initial focus on autism, oncology, neurology, and women's health, this partnership will combine the discoveries and research capabilities of UCSF with Quest's expertise in data pooling and analysis. The collaboration launches with two projects already underway. One aims to identify genetic mutations associated with autism to aid in its diagnosis, while the second focuses on identifying biomarkers to guide the treatment of glioma brain tumors. As a resource, scientists from both organizations will use laboratory-based diagnostics, imaging procedures, and population analysis based on Quest's national Health Trends database, which is the largest private clinical database in the U.S. Quest will then independently develop and validate any lab-developed tests for clinical use that emerge from the collaboration's research.

"Advances in technology and science have identified many promising opportunities to improve outcomes through insights revealed by novel diagnostic solutions, yet fulfilling the full potential of these opportunities often hinges on translational clinical studies which validate their value," said Jay Wohlgemuth, MD, senior vice president of science and innovation at Quest. "This unique collaboration between UCSF and Quest brings together the finest researchers and clinicians in the country to accelerate the development of a product pipeline of scientific discoveries as clinically valuable diagnostic solutions that enable precision medicine for improved outcomes."

Horizon Discovery and AstraZeneca Search for Novel Oncology Drug Targets
Horizon Discovery and AstraZeneca have extended their current partnership with an agreement to identify occurrences of synthetic lethality in oncology-relevant genotypes, and to validate these as drug targets. Synthetic lethality happens when a combination of mutations in two or more genes leads to cell death, but a mutation in one of those genes does not. These pairs of mutations could potentially be used to kill cancer cells while leaving normal cells relatively unharmed. Under the terms of this collaboration, Horizon will use its proprietary small interfering RNA platform to screen a set of genotypes for synthetic lethality. The company will then validate the resulting RNA interference hits using techniques such as pathway analysis, confirmation of activity in endogenously mutant versus wild type cell lines, functional assays, or gene knock-in/knockout assays. AstraZeneca may exercise exclusivity over any validated targets.

Regeneron, Geisinger Undertake Major Genetics Study
Regeneron Pharmaceuticals and Geisinger Health System have embarked on a major research collaboration to study the genetic causes of human disease. During the initial 5-year term of this partnership, Geisinger plans to collect samples from more than 100,000 patient volunteers, while Regeneron's wholly-owned subsidiary, Regeneron Genetics Center, performs sequencing and genotyping to generate de-identified genomic data. This study's participants comprise one of the biggest groups used in the U.S. for the analysis and sequencing of genetic material and comparison to long-term health outcomes. Regeneron and Geisinger intend the size and scope of this project to enable greater precision in identifying and validating the associations between genes and disease. To handle the large number of samples the study generates, the two parties will leverage Geisinger's state-of-the-art sample collection and storage capabilities, the MyCode biorepository, and extensive electronic medical records. Regeneron also intends to use its translational research and functional biology capabilities, including its VelociGene technology, to validate observed genetic associations.

Illumina and Amgen Partner on NGS-Based Co-Diagnostic for Colon Cancer
Illumina and Amgen are collaborating to develop and commercialize a multigene, next-generation sequencing (NGS)–based test as a companion diagnostic for Vectibix (panitumumab), a fully human anti-EGFR monoclonal antibody therapeutic for the treatment of metastatic colorectal cancer. As part of this agreement, the two companies will seek to validate a test platform that determines a patient's RAS mutation status and if treatment with Vectibix would be appropriate. The test will also be designed for use with Illumina's MiSeqDx instrument, the first NGS system to receive U.S. Food and Drug Administration clearance. As a multigene NGS panel, this test could potentially inform treatment decisions better than traditional technologies by providing a more complete genetic picture of patients' tumors, according to Rick Klausner, MD, chief medical officer and acting general manager of Illumina's Oncology business.

"NGS provides an advantage over traditional technologies that typically detect only one or a few variants," said Klausner. "We see the development of multigene diagnostic tests as a natural evolution to improve cancer care and outcomes."

Qiagen and Exosome to Develop Non-Invasive Test for Lung, Other Cancers
Qiagen has expanded its strategic partnership with Exosome Diagnostics to develop a novel blood-based test that will detect certain mutations of an undisclosed gene associated with non-small cell lung cancer and other malignancies. The test will have the potential for use as a co-diagnostic with several new cancer therapeutics. Its design will integrate Qiagen's sample technologies with proprietary technology from Exosome that enables non-invasive detection of disease-associated gene mutations and expressions without the need for a surgical tissue biopsy. Exosome's technology works by detecting and measuring the nucleic acids carried by exosomes and other microvesicles found in blood, urine, and cerebrospinal fluid.

Following clinical validation and regulatory approval of the test, Qiagen will have worldwide exclusive rights for commercialization.

VWR to Distribute MedMira's Rapid Testing Solutions
MedMira, a developer of rapid testing technologies and solutions, has signed a U.S. distribution agreement with VWR International. MedMira's tests enable the rapid detection of diseases such as HIV and hepatitis C in 3 minutes. Under the terms of this deal, VWR will sell MedMira's Miriad platform technology and Reveal G3 rapid HIV test, and plans to expand its portfolio to include more of MedMira's rapid testing products in the future. "MedMira's proven technology and rapid tests will offer our customers the benefits of faster test times and simplified test procedures," said Mark McLoughlin, senior vice president and president of VWR's U.S. lab business. "We are very excited to add MedMira's products to our extensive portfolio and to work closely with MedMira on their strategic U.S. expansion."