AstraZeneca, MHI to Search for Genes  Associated With CVD, Diabetes

AstraZeneca has joined forces with the Montreal Heart Institute (MHI) in Quebec, Canada to search the genomes of up to 80,000 patients for genes associated with cardiovascular disease and diabetes, their complications, and treatment outcomes. This is one of the largest such screens of its type to date and aims to enhance the medical community’s understanding of the biological mechanisms that underlie these conditions.

Under the terms of the collaboration, MHI will genotype up to 80,000 DNA samples from AstraZeneca’s extensive biobank. The samples include both tissue and blood samples, which have been collected over a period of 12 years under informed consent from patients who have entered clinical trials to test cardiovascular and diabetes treatments.

MHI’s Beaulieu-Saucier Pharmacogenomics Centre will initially use genome-wide single-nucleotide polymorphism analysis to identify regions of DNA that predispose one to or cause cardiovascular diseases and diabetes or that are associated with responses to treatments. MHI will then apply other technologies, such as next-generation sequencing, to carry out full gene sequencing of areas of interest to identify new genes associated with disease, with complications such as heart attacks, strokes, diabetic nephropathy, or retinopathy, and with treatment outcomes in terms of responsiveness to medication.

“The information will help us to develop new medicines for these conditions and to target them to patients who respond best using biomarkers and companion diagnostic tests,” said Ruth March, PhD, vice president of Personalized Healthcare and Biomarkers at AstraZeneca. “Together [with MHI] we are taking personalized healthcare beyond its great heritage in oncology to benefit patients with cardiovascular disease and diabetes.”

EMD Millipore to Leverage Singulex’s Single Molecule Counting Technology

EMD Millipore has been granted exclusive rights to further develop and commercialize Singulex’s single molecule counting (SMC) technology—including instruments, assays, and services—for research applications worldwide. Reliable, ultra-sensitive protein detection is a critical unmet need in life science research. Current technologies enable detection of only approximately 5% of proteins in the entire proteome due to the low abundance of many biomarkers, leaving the vast majority of proteins virtually undetectable. Singulex’s novel, patented SMC technology is used in the company’s Erenna immunoassay platform and combines signal enhancement and background reduction coupled with low volume sampling to achieve ultra-high sensitivity protein detection. Millipore plans to add the Erenna platform to its Protein Detection franchise.

“[This agreement] puts our unique technology into the best possible hands to optimize its commercial scale-up and market potential,” said Guido Baechler, president and CEO of Singulex. “This deal enables us to leverage our superior immunoassay technology to create additional opportunities in our other diagnostic businesses, especially within the area of companion diagnostics.”

ARUP, Labceutics to Support Development of Personalized Therapeutics

ARUP Laboratories has formed a strategic alliance with Labceutics to provide the pharmaceutical industry with access to novel test development and commercial testing services. With 60–70% of pharma pipelines dependent upon companion or complementary diagnostics, there is an increasing need to ensure the availability of high-quality novel tests that enable healthcare providers to prescribe the right drug at the right time to the right patient. However, novel diagnostics can take years to diffuse into laboratories serving prescribers in the U.S.

To address this problem, ARUP Laboratories created a novel program over the past several years called PharmaDx that provides customized test development and validation services, as well as clinical research and commercial testing, to meet the unique requirements of the pharmaceutical industry. By building on this model with Labceutics’ efforts to optimize pharma access to companion and complementary diagnostics, the two companies now aim to support targeted therapy launches and ongoing clinical testing with ARUP’s menu of novel emerging tests.

Biocartis, Fast-track Diagnostics Team on Multiplex Infectious Diseases Tests

Biocartis and Fast-track Diagnostics have formed a partnership to develop a range of Fast-track’s syndromic multiplex infectious diseases tests to run on the Biocartis Idylla system. Idylla is a fully-automated molecular diagnostics system that delivers rapid tests in virtually any setting, using almost any biological sample type, and without the need for pre-processing or specialist training. The first assay the collaboration will develop for it is a multiplex respiratory panel for the detection of viral and bacterial targets in upper respiratory tract infections.

Most current methods focus on detecting one or a few pathogens expected to be present in a patient sample. If the sample is negative, a new test will be performed for other pathogens, increasing the time to result. With the syndromic multiplex approach that Biocartis and Fast-track are taking, the initial test will not just look for the most likely pathogen, but also for a range of less likely pathogens, preventing the need to retest.

Biodesix Lung Cancer Prognostic Now Covered by Two Major Insurers

Biodesix’s VeriStrat test has received a positive coverage decision from United Healthcare, one of the largest commercial insurance companies in the U.S., and CareFirst Blue Cross Blue Shield, the largest healthcare insurer in the Mid-Atlantic region. VeriStrat is a blood-based proteomic test that provides physicians with prognostic and predictive information that helps guide treatment of advanced non-small cell lung cancer (NSCLC). Patients with a VeriStrat Poor test result have a shorter median overall survival than those with a VeriStrat Good result. This information can help guide physicians’ decisions on chemotherapy, palliative care, or clinical trials. A health economics study published in Lung Cancer in April 2015 demonstrated that treatment decisions based off of VeriStrat’s results improved overall survival for patients with NSCLC by more than 1 month, and also enhanced quality of life.

Horizon to Develop cfDNA Reference Standards for CareDx

CareDx and the Horizon Discovery Group division Horizon Diagnostics have entered into a collaboration to develop cell-free DNA (cfDNA) reference standards. These reference standards will be part of Horizon’s HDx reference standards offering and will support proficiency testing of CareDx’s solid organ transplant injury monitoring diagnostic tests, as well as being integrated into CLIA laboratory testing. HDx reference standards offer a source of genetically defined, quantitative, and sustainable reference material from an independent third party, which is critical to the validation and routine performance monitoring of CareDx’s next-generation sequencing (NGS)–based donor-derived cfDNA assay. The reference standards mimic plasma cfDNA in the transplant setting both in size and abundance and are the first commercially available standards of their kind.

“This new collaboration with CareDx demonstrates the importance of well-validated controls when developing clinical assays, especially as technologies such as NGS become more widely adopted for diagnostic use,” said Paul Morrill, PhD, president of products business at Horizon.