CLN Article

Industry Playbook

Theranos to Implement Laboratory Services at Cleveland Clinic

Theranos and Cleveland Clinic have entered a long-term strategic alliance with the aim of exploring the potential of Theranos’s less invasive testing technology to enhance clinical quality, improve turnaround times, and reduce the cost of care. Cleveland Clinic’s pathology team in the Robert J. Tomisch Pathology and Laboratory Medicine Institute will collaborate with Theranos to provide advanced clinical diagnostic services and, over time, implement Theranos’s CLIA-certified laboratory services for Cleveland Clinic.

According to Theranos, its proprietary phlebotomy process enables the company to run a full spectrum of laboratory tests, from common panels to highly specialized assays, on blood samples as small as a few drops. With this technology, the company hopes to eliminate the need for using larger needles and collecting the numerous vials of blood required for many lab tests. Theranos believes its minimally invasive sample collection will be particularly beneficial for patients receiving oncologic, pediatric, and other inpatient treatment requiring frequent blood draws. The company’s tests are priced at 50% or less of Medicare reimbursement rates to reduce the overall cost of care.

The long-term strategic collaboration between Theranos and Cleveland Clinic includes additional opportunities to pursue research studies, clinical trials, new test development, and the provision of reference laboratory services through Cleveland Clinic Laboratories. The collaboration may also extend to other Cleveland Clinic hospitals and family health centers.

Theranos currently provides laboratory services through its network of Theranos Wellness Centers, located inside Walgreens stores across Arizona and in Northern California.

Four Organizations Partner on Tool to Advance Colon Cancer Treatment

Selah Genomics, a subsidiary of EKF Diagnostics, has entered a four-way collaboration with Greenville Health System in Greenville, South Carolina, DecisionQ Corporation, and BD to improve clinical decision support in the treatment of colon cancer patients by uniting classic clinical annotations with proprietary next-generation sequencing (NGS) technology and artificial intelligence-based decision support algorithms. Using its PrecisionPath NGS technology, Selah Genomics will first determine the genetic profiles of tumor samples provided by the Institute for Translational Oncology Research, which is part of the Greenville Health System’s Cancer Institute. The samples, from colon cancer patients with known outcomes, will be provided with full clinical annotation. DecisionQ will then employ its advanced machine-learning platform to integrate genetic profile data with clinical annotations to produce a model designed to aid clinical decisions related to colon cancer treatment, specifically in the community-based setting. The research project is being funded in part by BD.

TGAC, Optalysys Partner to Reduce Energy Consumption of Genomic Analysis

The Genome Analysis Centre (TGAC) and high performance computing hardware provider Optalysys have joined forces to develop an optical processing device that will reduce by more than 95% the energy needed to perform large-scale DNA sequence searches for genomic research. As gene-sequencing technologies continue to evolve, public sequencing databases are doubling in size every 18 months or less, making it increasingly expensive for researchers to perform the extensive database searches needed to identify and understand newly sequenced genes.

A contributing factor to the prohibitive cost of searching such large databases is that they require access to large, high performance computing resources that consume vast amounts of energy for power and cooling. By developing a genetic search system with dramatically lower energy requirements, TGAC hopes to make genomic analysis available to a much broader base of companies and institutions which currently are unable to perform it due to capacity constraints and high costs.

Qiagen, 12 Other Organizations Form Allele Frequency Community

Qiagen has joined a coalition of 12 other life science and diagnostics organizations to form the Allele Frequency Community, an initiative whose aim is to create an extensive and ethnically diverse collection of human genomes that is freely accessible. To accomplish this, the Community’s 13 founding organizations have agreed to pool their extensive human exome- and genome-wide variant call datasets in a secure and anonymized fashion.

Until now, labs often collected their own private allele frequency libraries, but did not have the infrastructure and incentives to integrate their resources into a freely available community asset. By developing a centralized, public library, the Allele Frequency Community hopes to increase the accuracy of findings from data generated by molecular analyses, such as next-generation sequencing. The Community’s database already holds more than 70,000 variant call datasets, including 8,000 whole genomes, and has been shown in internal benchmarking studies to generate a 43% average reduction in false-positive rates in causal variant identification.

Other founding collaborators of the Allele Frequency Community include Columbia University Institute for Genomic Medicine, Emory Genetics Laboratory, Icahn Institute for Genomics and Multiscale Biology at Mount Sinai, LabCorp business Enlighten Health Genomics, New York Genome Center, and Weill Cornell Medical College.

Illumina Files Lawsuit Against Premaitha as Company Makes First European Sale

Illumina and its wholly-owned subsidiary Verinata Health have filed a patent infringement suit against Premaitha in the U.K. asserting that Premaitha’s Iona test infringes upon European Patent (UK) 0 994 963 B2 and European Patent (UK) 1 981 995 B1. The Iona test is the first non-invasive prenatal test (NIPT) product to receive the CE mark, and uses next-generation sequencing technology to estimate the risk of a fetus having trisomies 21, 18, and 13 by analyzing cell-free fetal DNA from a sample of maternal blood.

The announcement of this suit coincided with Premaitha Health inking a deal with Esperite, under the terms of which Esperite’s subsidiary, Genoma, will have the right to use Premaitha’s Iona test for its NIPT service. As Premaitha’s first sale in Europe, this agreement with Genoma marks a major milestone in the company’s efforts to accelerate the broad dissemination of NIPT in Europe with its Iona test. In a prepared statement, the directors of Premaitha Health stated that they do not believe that the Iona test infringes the patents as claimed by Illumina.

Biodesix, Inivata Collaborate on Lung Cancer Liquid Biopsy

Biodesix and Inivata have teamed to develop and commercialize next-generation sequencing (NGS) blood-based tests for clinical applications in lung cancer. “Approximately 30% of [non-small cell lung cancer] patients are unable to obtain a biopsy or have insufficient tissue from a lung cancer biopsy to provide the diagnostic information needed for their care,” said Inivata CEO Michael Stocum. “Blood-based diagnostics can make a real difference in such cases. Using Inivata’s circulating tumor DNA analysis platform, we can now provide information that was previously unattainable for these patients, leading to better outcomes.”

This agreement will leverage Inivata’s proprietary NGS technology platform, Tam-Seq, as well as Biodesix’ development and commercialization capabilities in the U.S. market. Under its terms, the two companies will use Inivata’s platform to conduct jointly funded studies to establish the clinical utility of an NGS-based test for non-small cell lung cancer, and will initiate an observational study later this year.