Genetic Engineering & Biotechnology News

MAY15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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6 | MAY 15, 2017 | | Genetic Engineering & Biotechnology News Gail Dutton Synthego is applying the Agile development methods and entrepreneurial lessons its founders learned at SpaceX to biotech, with the eventual goal of developing a virtual cloud laboratory offering biology as a ser- vice. Its flagship product, CRISPRevolution, is the first step. It streamlines gene editing so that even researchers new to the techniques can succeed. "CRISPRevolution is a family of kits, custom libraries, and other products in the genome engineering space," co-founder and CEO Paul Dabrowski says. "It includes the world's first synthetic single guide RNA kit for CRISPR genome engineering." The ability to manipulate RNA is one of the key components of the genome engi- neering workflow, but creating RNA in the laboratory is traditionally difficult. Synthetic RNA can shave as much as one week off CRISPR experiments, eliminating the need to design, construct, and verify sequences, and avoiding the purification of plasmid or in vitro-transcribed RNA. Synthego's synthetic RNA is completely free of DNA and "allows scientists to manip- ulate the cell much better," Dabrowski notes. It offers up to 90% knockout efficiency. "The quality of our RNA is higher than scientists typically can create in the field, so high-fidelity editing is possible," he con- tinues. "Because the CRISPR functions can be more precise, cells can be modified more quickly than with other methods. For exam- ple, CRISPRevolution enables results to be generated in a couple of days rather than in a couple of weeks." Some of the speed emanates from sim- plifying the validation process. Although validation is still required, CRISPRevolution modifies 80–90% of the cells correctly ver- sus about 10–30% of those created by older technologies. Scientists, therefore, are more likely to successfully validate edited cells each time. The Future of CRISPR Research Synthego's 2017 Future of CRISPR Re- search report indicates that 87% of new CRISPR users are also new to gene edit- ing. "That's both surprising and telling," remarks Sam Liu, Synthego's vice presi- dent of commercial marketing. "It shows the appeal and power of CRISPR, which brings new scientists into gene editing and increases the population of researchers." Those researchers will require a new gen- eration of tools that streamline the work, thereby delivering results faster and more efficiently. Dabrowski and Liu say it's too early to discuss new products in development, but Synthego's team is addressing challenges in efficiency, verification of edits, and delivery/ transfection—the top three pain points in gene editing. "We want world-class tools for all researchers," Dabrowski emphasizes. The patent lawsuits surrounding CRIS- PR haven't affected Synthego. "Our tech- nology is focused on the basic hardware and software to run the scientific workflow related to gene editing," Dabrowski insists. "We're closely engaged with all the play- ers in CRISPR's development, and they see these kits as adding value to their intellec- tual property flow." SpaceX Methods Port to Biotech Synthego founders Paul and Michael Dabrowski were once engineers at SpaceX. That experience introduced the brothers to an innovative, entrepreneurial culture based on Agile methodology and agile thinking. Agile development methods are based on close collaboration among stake- holders to develop projects in smaller, itera- tive steps—typically every few weeks. Con- sequently, missteps are minimized because course corrections are made throughout development. That was perfect for SpaceX and its grand vision to help colonize Mars. SpaceX engineers realized that rapid iteration could make a huge impact. "The ability to write and test code within hours was important, so SpaceX manufacturing and testing engineers Synthetic RNA: One Small Step for Synthego, One Giant Leap for Biology as a Service SpaceX-Style Gene Editing Achieves Liftoff Corporate Profile Synthego's CRISPRevolution is a portfolio of synthetic RNA designed for CRISPR genome editing and research. The company's offerings include sgRNA kits, cr:tracrRNA kits, and custom and modified RNA. According to Synthego, the benefits of synthetic RNA over plasmid-derived or in vitro-transcribed guides include faster transfection readiness, greater accuracy and consistency, less laboratory time, and lower labor costs. Insights Industry Watch Abbott Laboratories and Alere have good reason to expect their long-planned merger to be completed by the third quarter as announced, following an agree- ment that revises key pieces of the deal. The revised deal cuts the price Abbott will pay for the diagnostics developer from $5.8 billion to $5.3 billion—by lowering the per-share price of Alere stock from $56 to $51. "We believe shareholders would have approved anything at $50+ so we expect majority shareholder approval will not be a problem," Canaccord Genuity diagnostics analyst Mark Massaro said in a note to in- vestors. "We are positive, relieved, and modestly surprised by the news." The settlement was less surprising, Reuters columnist Robert Cyran observed, given the difficulty of walking away from a mergers and acquisitions agreement based on a "material adverse change" (MAC) in circumstances since the deal was reached. That difficulty, according to Cyran, stems from a 2001 court case in which the Delaware Court of Chancery defined a MAC as "unknown events that substantially threaten the overall earnings potential of the target in a durationally significant manner." Abbott contended late last year that a MAC had occurred which warranted ending the acquisition deal. Abbott sued Alere in December in Delaware Chancery Court, citing a "substantial" 42% loss in Alere's value due to a series of developments since the companies announced their plans to merge on February 1, 2016. Among developments cited by Abbott were: • Multiple U.S. Justice Department subpoenas served on Alere • A Centers for Medicare & Medicaid Services decision to revoke the billing privileges of Alere's Arriva Medical division • The permanent removal from the market of Alere's INRatio® and INRatio2® PT/INR Monitoring System • Alere's five-month delay in filing its 10K annual report, coupled with restatement of its 2013–2015 financials Abbott's lawsuit was just the latest in a legal back-and- forth between the companies. In August, Alere sued Abbott, seeking to force completion of the deal by pursuing clear- ance in accordance with federal antitrust law. In amending their acquisition agreement, Abbott and Alere agreed to dismiss the lawsuits each filed against the other. n With M&A Marriage Easier Than Divorce—Abbott, Alere Headed at Last for the Altar

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