QIAGEN, iSpecimen, Riffyn, And More: News From October 2018

October 31, 2018 | October featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including QIAGEN, iSpecimen, Riffyn, and more.

QIAGEN announced the launch of a breakthrough technology enabling faster, simpler library preparation for RNA sequencing. A key element of this portfolio is the QIAseq FastSelectRNA Removal Kit which provides a novel solution for scientists to target RNA types that are irrelevant to their research and remove them from RNA-seq libraries for next-generation sequencing (NGS). The global market size for library preparation kits for RNA-seq is believed to be about $400 million. “The QIAseq FastSelect RNA Removal Kit allows rapid selective removal of RNA classes from any sample, even the most difficult FFPE samples, enabling researchers to attain high quality, reproducible RNA sequencing results while at the same time minimizing time requirements and cost. The QIAseq Fastselect RNA kit can accomplish in one simple workflow step what current RNA sequencing library preparation solutions achieve in over 30 steps. By using a range of proprietary, novel technologies, the QIAseq FastSelect RNA Removal kit therefore radically simplifies and speeds up RNA removal. Off-the-shelf options include rRNA or globin mRNA removal, while custom RNA removal solutions for selected transcripts can be designed by QIAGEN,” said Thomas Schweins, Senior Vice President of QIAGEN’s Life Sciences Business Area, in a press release. Press release

Riffyn has launched Riffyn Open Access which provides free use of its patented Scientific Development Environment (SDE) to any member of a non-profit organization. Open Access users have a full-featured Riffyn SDE account to create and openly share reusable experimental methods and data on the platform. “Riffyn SDE represents a paradigm shift in the design, execution and sharing of scientific procedures and data analysis,” Timothy Gardner, Founder/CEO of Riffyn, said in a press release. “Riffyn SDE has undergone four years of intensive development in industrial biotech and pharmaceutical R&D settings. We felt it was time to offer the capability openly to the academic community, most of whom do not have the means to implement industrially-proven data systems like Riffyn SDE.” Riffyn SDE was created to address the crisis in scientific reproducibility and demands for more cost-efficient drug development. Its potential to transform the quality and reusability of scientific work was recently demonstrated in a ground-breaking study published in Scientific Data by Delft University of Technology and Riffyn. The study harnessed Riffyn SDE to execute a complex set of microbial fermentation experiments. Press release

DNA Script announced that it has successfully synthesized the world’s first 150-nucleotide (nt) strand of DNA by de novo enzymatic synthesis. DNA Script’s enzymatic approach reaches up to 99.5% efficacy for each nucleotide added, achieving parity with traditional chemical synthesis. “The technology developed by DNA Script is now on par with the performance of current commercial solutions done with the aid of phosphoramidite reagents. DNA Script is the first organization — commercial or academic — to demonstrate the feasibility of enzymatic DNA synthesis, proving the incredible potential of this nascent technology. In May, we announced a world-first with the enzymatic synthesis of a 50 nt strand of DNA, and we have been able to triple our performance in just four months. By 2019, we expect to be able to synthesize DNA strands several hundred nucleotides in length. The speed at which our enzymatic synthesis technique has progressed — from a single incorporation to 150 nt in just four years — significantly outperforms the historical trend for phosphoramidite chemistry,” said Thomas Ybert, CEO and cofounder of DNA Script, in a press release. In the experiments routinely run by the R&D team at DNA Script, sequences of the four natural nucleotides are randomly generated in silico and then automatically synthesized in vitro on the hardware platform developed by the company, without any physical template. Press release

iSpecimen has significantly upgraded its online exchange for biospecimens, making it easier for healthcare organizations to offer their valuable biospecimen collections to researchers around the world, and for researchers to obtain the specimens they desperately need. iSpecimen Marketplace 2.0 went online today, and the newly enhanced platform remains free for researchers and suppliers to join. The iSpecimen Marketplace, launched in 2017, is an online exchange designed to close the specimen gap that prevents researchers from readily obtaining the biofluids, tissues and cells they need to develop new therapeutics and diagnostics. Doing for research what Amazon has done for reading, the marketplace also addresses biobanks' financial sustainability challenges and the expectations of philanthropic patients. Press release

Spectra Logic announced that the Advanced Computing Center for Research and Education (ACCRE) at Vanderbilt University has deployed a Spectra T950 Tape Library and Spectra BlackPearl Converged Storage System to store and archive research data. ACCRE is the foremost resource for the high-performance computing (HPC) requirements of the various research projects across the Vanderbilt community. The ACCRE cluster is used for research in a wide variety of fields, including genetics research, particle physics, and astronomy. ACCRE processes and stores data produced by more than 850 researchers across more than 50 departments and centers within Vanderbilt University. The center needed to increase capacity, due to expected growth estimated to reach 10PB by the end of 2018, and significantly higher by 2020. Various departments, research teams, and grant projects rely on ACCRE for many services, from accessing their Big Data cluster to utilizing their large high-bandwidth storage network, to employing their tape backup services. With guidance from Teradactyl, a company specializing in complex heterogeneous computing environments that include specialty file systems for high performance computing and wide area networks, ACCRE upgraded to a Spectra T950 Tape Library with 11 LTO-8 tape drives and an additional media frame. The center also deployed a Spectra Black Pearl Converged Storage System, enabling direct end user access to archival storage. The BlackPearl design supports numerous concurrent workflows by eliminating the need for costly third-party data movers through its integration of Spectra S3 with a range of certified clients and simple file movers. This object storage platform combines NAS and Spectra S3-based interface with multiple storage targets, creating a simple and affordable solution. Press release

Vineti announced the appointment of Christophe Suchet as Chief Product Officer. Suchet joins Vineti's industry-leading, multi-disciplinary team and will oversee product and ecosystem innovation and compliance. He will also be a key member of the team developing solutions for Vineti's cell and gene therapy clients and partners. Suchet brings more than 20 years of information technology and senior executive experience consulting to, developing, and deploying innovative IT solutions for leading biopharmaceutical companies. With cell and gene therapy expertise in high demand, Suchet's experience and track record will bring invaluable, seasoned insights to Vineti and its customers. "Christophe is an exceptional leader and pioneer in the critical technologies that enable the cell and gene therapy industry," said Amy DuRoss, CEO and Co-Founder of Vineti, in a press release. "His experience further expands the impact of the Vineti platform and team, and we are pleased to have him join us as Product lead. As we scale our business, his experience knitting together complex, cloud-based systems will be invaluable in addressing the unique opportunities and challenges of moving new therapies through clinical trials and into mainstream medicine." Press release

Genetics Research announced that the U.S. Patent and Trademark Office granted the Company U.S. Patent No. 10,081,829, entitled "Detection of targeted sequence regions.” The patent covers a novel method for enriching sequence specific nucleic acids called Negative Enrichment, in which Cas endonuclease complexes are used to protect targeted sequences of interest in the presence of exonucleases. The exonucleases degrade substantially all of the nucleic acid in a sample except for the nucleic acid of interest, leaving the nucleic acid of interest isolated and amenable to analysis. In a press release Tony Shuber, President and COO of Genetics Research, said, “Our Negative Enrichmentplatform is agnostic to the size of the targeted sequence of interest, and our research team has demonstrated the ability to apply our Cas9-associated Negative Enrichmentplatform to multiple, sequence-specific applications. These include long DNA analysis and short fragment enrichment, such as circulating cfDNA. We have also taken advantage of the specificity associated with Cas9/sgRNA complexes and can demonstrate the ability to achieve single base discrimination by Negative Enrichment.” Press release

Nu-Med Plus announced a new articulation of the startup’s unique and patented technology through the medical device company’s website: https://nu-medplus.com/. Nu-Med Plus engineers and builds the next generation of nitric oxide delivery systems. Jeff Robins CEO of Nu-Med Plus said in a press release, “The patented and patent-pending technology Nu-Med Plus is building to safely deliver nitric oxide is being purpose-built to disrupt current markets and open new markets. Those markets in the treatment of malaria, COPD, tuberculosis, ARDS and wound healing present billions of dollars in annual value and more importantly present the potential to save and better millions of lives.” Press release

Rgenix announced that it has raised $40 million in a Series C financing in support of further development of the company’s clinical and pre-clinical oncology programs and for general corporate purposes. The Series C financing was led by Lepu Medical, a publicly traded global healthcare firm, and includes Oceanpine Capital and WuXi AppTec’s Corporate Venture Fund. Existing investors also participated in the financing round, including Novo Holdings A/S, Sofinnova Partners, Alexandria Venture Investments, and the Partnership Fund for New York City’s Innovate NY Fund and associated entities. The financing will support Phase 1b/2 clinical trials of the lead program RGX-104 in multiple cancer indications, including in checkpoint inhibitor refractory patients. It will also support early clinical development of RGX-202, a first-in-class cancer metabolism program, as well as discovery stage programs arising from the Rgenix target discovery platform. Press release

Certara announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access. “We are experiencing a period of unprecedented growth in science and technology,” said Synchrogenix President Kelley Kendle, in a press release. “The promise of distributed ledger technologies, such as those used by other highly regulated industries, including financial, legal and insurance, and now in life sciences, is to create an open, transparent and yet confidential infrastructure to reap the many benefits of that explosive growth. For example, by digitizing R&D, lifecycle management, and real-world evidence data in a secure and trusted manner, we can identify the right patients at the right time for a given treatment, while maintaining trust and privacy for all stakeholders. We can also enhance patients’ ability to manage, engage and control how their data can be used to further innovation or advance the availability of treatments.” Press release

Conversant Bio, Folio Bio, Discovery Life Sciences, and Phylogeny announced that they have merged under the name Discovery Life Sciences (Discovery) to create a global market leader in biospecimen analysis and procurement for the pharmaceutical, biotechnology and diagnostics industries. The new company will leverage deep scientific expertise and consultative services, combined with the largest repository of more than 10 million research-quality biospecimens—all available and processed for analysis—to accelerate the discovery, research, and development of novel biomarkers, drug candidates, and diagnostics. Water Street Healthcare Partners, a strategic investor focused exclusively on the healthcare industry, facilitated the merger and invested in the company. Press release

Simplify announced that it has appointed Cindy Lynch to Vice President, General Counsel. Lynch has nearly 15 years of experience providing strategic legal and intellectual property advice to medical device startups. Lynch’s appointment comes at a time when Simplify is expanding commercial efforts in Europe and nearing completion of its two-level U.S. IDE clinical trial for the implantation of its cervical artificial disc. The Company completed enrollment of its one-level trial in February 2018 with 166 patients enrolled at 16 U.S. sites and anticipates complete enrollment of 200 patients at 18 centers in its two-level study by the end of 2018. Lynch specializes in intellectual property law and business venture advising. Prior to consulting for companies including Simplify as in-house Counsel, she worked as the VP of Intellectual Property at Elixir Medical Corporation, Moximed, SpinalMotion, Conor Medsystems, and as a partner at Burns, Doane, Swecker & Mathis. Press release

Abbott has announced the launch of two web-based laboratory information management systems to enable laboratories to make data management simpler, better integrated, and more user-friendly. STARLIMS Life Sciences Solution CL 11.0, which includes the industries of pre-clinical, clinical research, biorepository, molecular and academic research, and STARLIMS Quality Manufacturing Solution QM 11.1, which includes the industries of pharmaceutical, biotech, chemical, food and beverage and petrochemical/refining, are both new offerings built on the latest version of the STARLIMS Technology platform 11.6. Continual improvements in laboratory information management system (LIMS) platforms are crucial as regulatory scrutiny increases, the amount of data grows exponentially, many industries move towards molecular testing and precision medicine, and pressure mounts to bring new products to market faster. Both new products are fully integrated solutions, which include an Advanced Analytics platform. Advanced Analytics allows clients to analyze lab data via enhanced data visualization capabilities, which enables better, faster, and business-critical, decision making. The integrated solution also includes a Scientific Data Management System (SDMS), Electronic Laboratory Notebook (ELN), and mobile capabilities, with a powerful LIMS as the centerpiece. Press release

DNAnexus announced DNAnexus Apollo, an enhanced platform for clinico-genomic data science exploration, analysis, and discovery. Global pharmaceutical research and development (R&D) teams can leverage DNAnexus Apollo in their translational informatics research to rapidly test multiple hypotheses and gain valuable insight into mechanisms of action, biomarkers, and targets. Moving from the initial stages of target identification through clinical development remains a significant challenge for biopharmaceutical companies. In order to achieve actionable insights, pharmaceutical R&D teams need access to massive volumes of combined clinical and genomic data, paired with a robust informatics strategy, to interrogate the data for targets and biomarkers of disease progression and therapy response. To address these challenges DNAnexus Apollo provides a scalable cloud environment, flexible data models, and intuitive analysis and visualization tools to simplify research workflows for R&D teams globally. Working with clinical data requires specialized capabilities to maintain privacy, DNAnexus Apollo leverages the same best-in-class DNAnexus security and privacy framework, which includes compliance in accordance with HIPAA, CLIA, GxP, and FedRAMP, among others. Press release

Eaton has announced the latest version of its Intelligent Power Manager (IPM) software – power management software for virtual environments – which allows for integration with the company’s Docker container platform and Kubernetes container orchestration solution. The integration means that data center and IT professionals can automate the remote shutdown of container-based infrastructure in response to unplanned power events in order to ensure business continuity and to protect mission critical data. Eaton’s IPM software lets managers monitor and manage power devices in virtual environments. The latest version software ensures system uptime, continuity and data integrity by allowing for remote monitoring, management and control of UPSs and other devices on the network. Additionally, the integration of Docker and Kubernetes with IPM provides users with another opportunity to drive recurring revenue by providing their end customers with a complete power management strategy that meets their unique application needs as they continue to transition to cloud and hybrid infrastructures, Eaton says. Press release

Cybrexa announced that it has expanded its Scientific Advisory Board with the appointments of Geoffrey Shapiro, Director of the Dana-Farber Cancer Institute, and Timothy Yap, MRCP(UK), BSc (Hons), PgDip of The University of Texas MD Anderson Cancer Center. Per Hellsund, President & CEO of Cybrexa, said in a press release, “Cybrexa is currently at a major inflection point as we rapidly move toward entering the clinic with the first candidate generated from our paradigm-changing tumor-selective technology platform. Dr. Shapiro and Dr. Yap both bring a wealth of knowledge and experience that is critical as we transform into a clinical-stage company. In particular, Dr. Shapiro’s expertise in the preclinical and clinical development of molecules exploiting cell cycle and DNA repair-related proteins and Dr. Yap’s expertise in first-in-human and combinatorial development of molecularly targeted agents, especially those targeting of the DNA damage response, will be instrumental in our clinical development. These important additions further expand Cybrexa’s collective depth of knowledge and we look forward to their contributions.” Press release

ACD/Labs announced significant updates across its ACD/Spectrus and Percepta platforms. Version 2018.1 delivers greater functionality to all ACD/Labs products, including key tools for analytical and process chemists in pharmaceutical development, NMR spectroscopists, mass spectrometrists, plus LC and GC method development specialists. "Scientific organizations expect a wealth of innovative capabilities in the applications they use to help them solve their most complex scientific challenges. But, they also expect those applications to be continually updated and improved," Andrew Anderson, Vice President of Innovation and Informatics Strategy at ACD/Labs, said in a press release. "This software release offers a wealth of new and valuable functionality—we believe it represents a commitment to our customers to help them improve their productivity, provide deep scientific insight, and facilitate decision-making." ACD/Labs' v2018.1 software release includes analytical knowledge management in pharmaceutical development, NMR and MS dereplication, usability improvements to method development solutions, and physicochemical and ADME/Tox property prediction. Press release

Rigel announced that it had entered into an exclusive license and supply agreement with Kissei to develop and commercialize TAVALISSE in all current and potential indications in Japan, China, Taiwan and the Republic of Korea. Kissei is a Japan-based pharmaceutical company addressing patients' unmet medical needs through its research, development and commercialization efforts, as well as through collaborations with partners. TAVALISSE is commercially available in the U.S. for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Under the terms of the agreement, Rigel will receive an upfront cash payment of $33 million, with the potential for an additional $147 million in development and commercial milestone payments, and will receive product transfer price payments in the mid to upper twenty percent range based on tiered net sales for the exclusive supply of TAVALISSE. Kissei receives exclusive rights to TAVALISSE in ITP and all future indications in Japan, China, Taiwan, and the Republic of Korea. Rigel retains the global rights, excluding these Asian countries, to develop and commercialize TAVALISSE in ITP and any additional indications. Press release

Cofactor announced the launch of a RNA-based immune profiling kit developed for laboratories wishing to derive the immune composition of tumor samples. The tumor’s immune composition is proving to be a valuable indicator of response to current immunotherapies and the numerous drugs in development. Using the ImmunoPrism Immune Profiling Kit, laboratories now have access to the same kit Cofactor Genomics uses to prep, sequence and analyze against Cofactor’s database of machine-learning optimized immune reference expression models. The launch of the kit follows recent ImmunoPrism announcements on collaborations with The Fred Hutchinson Cancer Research Center and the National Cancer Institute (NCI), and most recently, the clinical accreditation of the assay by the College of American Pathologists within Cofactor’s CAP/CLIA lab. Press release