Medherant, EightSpokes, Cambridge Semantics, And More: News From November 2017

December 5, 2017 | November featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including Medherant, EightSpokes, Cambridge Semantics, and more.

Medherant announced they have been awarded the “Excellence in Science & Technology Award” at the Coventry Telegraph Business Awards. These Awards are a celebration of companies in Coventry and Warwickshire which have achieved success for themselves, their staff and their customers. The award recognizes Medherant’s rapid progress and innovation in the development of next-generation transdermal drug delivery patches. Medherant, founded by David Haddleton and the University of Warwick in 2015, has created a drug delivery platform, TEPI Patch, designed to address many of the disadvantages of previous transdermal drug delivery patches. It enables a wider range of drugs to be delivered through the skin, has increased drug loading capacity, and provides a better patient user experience than patches currently on the market. Medherant has also developed a high-throughput system for assessing the rate of drug delivery from its patches, which enables the company to rapidly test a range of potential formulations for each drug and optimise the final product. The company is already working with pharmaceutical companies to test their drugs in its TEPI Patch platform. Press release

EightSpokes introduced Peer-to-Peer (P2P) Feedback with its latest release of Enlighten, the world’s first cloud-based Enterprise Project Collaboration (EPC) solution. It enables real-time feedback from colleagues collaborating on a project – from drug development to commercialization. With P2P Feedback, users can ensure that every assignment achieves its intended outcome and that team members receive timely and relevant feedback to course-correct as needed, while it still matters. It also naturally propels organizations to continuously improve performance, ultimately ratcheting employee engagement enterprise-wide. P2P Feedback allows colleagues to privately offer candid feedback to one another without reprisal from superiors for continuous improvement over the course of a project. In the Enlighten dashboard, all task assigners are alerted when a task is completed. Then, they are asked to rate the quality of the work completed using a simple scale of one to five stars. The tool then enables assigners to fine-tune their assessment using various attributes of work quality, such as accuracy, completeness, and resourcefulness. Last, assigners can provide freehand feedback to add clarity or provide suggestions. Enlighten EPC connects and aligns everyone who touches a project – from regulatory, medical affairs, market access, and supply chain stakeholders…to sales and marketing teams. It is an entirely new category of software, and unlike traditional project management tools in its ability to clearly show the many important interdependencies across teams around the world. With the integration of P2P Feedback, Enlighten helps improve the quality of deliverables at every step. Press release

Cambridge Semantics announced multi-cloud support for Anzo Smart Data Lake (SDL) 4.0, its flagship product that brings business meaning to all enterprise data. Incorporating several new technical advancements designed to deliver a generational shift over current data lake, data management and data analytics offerings, Anzo SDL 4.0 now supports all three major cloud platforms - Google Cloud Platform, Amazon Web Services (AWS), and Microsoft Azure. The vision for multi-cloud capability enabled by Anzo will allow enterprises to choose from any combination of on-premise, hybrid cloud or multi-cloud solutions that makes the most sense for their business environment. “Organizations today view their data assets as key business drivers for competitive advantage,” said Sean Martin, CTO of Cambridge Semantics, in a press release. “However, for many, the cost of running analytic solutions is drastically increasing, while speed-to-deployment remains a major challenge. Therefore, we are seeing an accelerated movement to the cloud and its variable cost model.” Press release

GenomeWeb has a nice look at BGI’s testing plans for a sequencing-based HPV test that relies on self-sampling technology for screening women for cervical cancer in rural areas of China. Na Liu, BGI Genomics' vice president, said that the China Food and Drug Administration (CFDA) approved the test in June to run on the BGISEQ-100, one of BGI's internally developed CFDA-approved sequencers that is based on semiconductor sequencing technology similar to that of Thermo Fisher's Ion Torrent. Full article

In collaboration with University of Heidelberg, Germany, results from a clinical study of pancreatic cancer is published in the Pancreas scientific journal. The results demonstrate that Biovica’s DiviTum assay can provide an accurate prognosis and evaluation of treatment efficacy. The proof of concept study, including 404 patients, provides evidence for using DiviTum as a dynamic biomarker before and during therapy to give important answers regarding prognosis and how effective therapy is. Biovica’s assay was prognostic for overall survival in all patients. For patients receiving therapy ahead of surgery, preoperative low DiviTum values demonstrated significantly higher overall survival compared to patients with high values. Pancreatic cancer is one of the deadliest forms of cancer. Hence, tools that can provide more and early information regarding the disease is in great need. With better and faster evaluation of treatments Biovica aims to provide a better tool when evaluating therapy options. The study provides additional evidence and future expanded clinical potential outside of breast cancer for DiviTum. The DiviTum assay determines thymidine kinase activity in a blood sample and is a practical, non-invasive tool for predicting outcome and monitoring efficacy in solid tumors. Biovica have an ongoing trial program including more than 10 clinical studies and 1,500 patients to document the unique capabilities of the assay in solid tumors. Press release

BioDiscovery launched, at the 2017 American Society of Human Genetics Meeting, a unique software solution for interrogation of copy number, sequence variants, and allelic changes obtained from a single NGS assay. NxClinical 4.0 is a system that brings together cytogenetics and molecular genetics to increase diagnostic yield while decreasing costs. Typical testing procedures involve isolated analyses of copy number/allelic changes and sequence variant changes, and when both are required they involve multiple tests in a sequential manner prolonging return of a diagnosis. Not only does this increase costs in obtaining, maintaining, and training on different systems or reagents for wet lab work and instrumentation for analysis, but it can also lead to overlooking compound events in a single case. NxClinical 4.0 derives copy number and AOH changes directly from the same NGS assay used for sequence variant analysis. The system then incorporates all these genomic variations into a single database system where a compound heterozygous event can easily be detected with interactive browser view and advanced filtering schemas that quickly narrow down the list of potential causal variants. “Obtaining copy number from sequencing data is now gaining momentum in the clinical market. We developed this capability several years ago and it has been available in our research product, Nexus Copy Number, for many years. Since then, the algorithm has evolved to its 4th generation with good enough performance to be incorporated into NxClinical, to enable clinical labs to achieve a single assay system for genetic testing,” said Soheil Shams, President, BioDiscovery, in a press release. Press release

Dolomite Bio announced the launch of the Nadia single cell platform, a groundbreaking system set to escalate scRNA-Seq to new heights, offering the fast-growing single cell research sector an innovative solution for a wide range of potential applications. The Nadia instrument is a touchscreen-controlled, droplet-based microfluidic platform for single cell research, combining superior microfluidics, automated temperature control and gentle cell/bead agitation to offer a single compact instrument that delivers highly precise and reliable results. One, two, four, or eight samples can be run in parallel, generating up to 6,000 high quality, single cell libraries per sample in approximately 15 minutes. Configuration with the Nadia Innovate protocol development platform transforms the system into a scalable, open system for the creation of new procedures and applications. Users can alter parameters – such as droplet size and frequency, temperature, agitation and timings – and optimize protocols with the aid of real-time visualization, enabling straightforward development of new single cell protocols and applications. Press release

ACH Foam Technologies announces DuraTherm PLUS+, an advanced cold chain shipping solution that assures payload temperatures remain between 2⁰ to 8⁰ Celsius for a 24-hour delivery window. Validated to International Safe Transit Association (ISTA) 7D standards, DuraTherm PLUS+ is available in summer and winter profiles to accommodate off-the-shelf seasonal packout solutions for pharmaceuticals and other products with acute temperature sensitivity. “The ISTA’s validation of DuraTherm PLUS+sets a high benchmark and will provide customers great confidence in their product’s protection during shipment,” says Frank Kiesecker, Senior Vice President Sales & Marketing with ACH Foam Technologies, in a press release. ISTA’s rigorous testing assures that product temperatures can be controlled within a very narrow range for up to 24-hours. DuraTherm PLUS+ is also pre-qualified to ISTA 7E for summer and winter profiles. A key facet of DuraTherm PLUS+’s ability to maintain near-constant temperatures is the expanded polystyrene (EPS) foam cooler core, which boasts superior insulation properties. ACH Foam Technologies’ laboratory developed packaging kit includes the DuraTherm PLUS+ cooler, inner payload packaging, gel pack refrigerants, outer corrugated shipping box, and precise packout instructions. Press release

Celmatix announced that the Fertilome genetic test has received full regulatory approval by the New York State (NYS) Department of Health (DOH) Clinical Laboratory Evaluation Program (CLEP). The Fertilome test is the first multigene panel test for reproductive conditions to be approved by NYS, which is known for having the most stringent requirements of the state agencies that regulate laboratory developed tests (LDTs). LDTs are not currently regulated by the FDA. Announced in January 2017, the Fertilome test has already been ordered for hundreds of women by over 80 reproductive specialists and OB-GYNs in the U.S. through a pre-approval program administered by NYS. The test offers physicians genetic insights into how a woman’s DNA may be impacting her reproductive health in sub-clinical ways that may not be apparent through traditional fertility tests that interrogate hormone levels. The test was developed after seven years of research. Celmatix scientists combined insights from over 1.1 million data points from more than 5,000 published clinical studies with findings from thousands of functional studies. This big data analysis resulted in the identification and statistical validation of 49 variants in 32 genes that have been associated with reproductive conditions that can impact a woman’s fertility including endometriosis, recurrent pregnancy loss, polycystic ovary syndrome, and early menopause. “We chose to launch in New York--the only state that requires that a test demonstrate both clinical validity and clinical utility to be eligible for approval--because from the beginning, we were committed to creating a test that is both clinically valid and useful,” said Piraye Yurttas Beim, Founder and CEO of Celmatix, in a press release. “We are very sensitive to the emotional and financial burdens on women considering egg freezing or undergoing fertility treatments. Personalized medicine, which leverages genetic insights about an individual to guide treatment and counseling decisions, is nascent in the field of reproductive health. Many genomics companies launch in New York State last or not at all because of the high bar set by the NYS DOH. We felt it was important, both to deliver peace of mind to our customers and also to set the standards high for the field, to hold ourselves to the highest standards from day one.” Press release

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