Clinical OMICS

MAY-JUN 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 43 of 50 42 Clinical OMICs May/June 2019 S herlock Biosciences isn't named for Sherlock Holmes, but for one of its foundational platform technolo- gies, officially called "Specific High-sensitivity Enzymatic Reporter unLOCKing," and licensed from the Broad Insti- tute of MIT and Harvard. Just as Sir Arthur Conan Doyle's fictional detective combed for clues using observation and deduction, SHERLOCK is designed to detect genetic fin- gerprints across multiple organisms or sample types, as described in four papers published in Science. Sherlock is also developing INSPECTR (INternal Splint-Pairing Expression Cassette Translation Reaction), a synthetic biology-based molecular diagnostics platform that can be programmed to distinguish targets based on a sin- gle nucleotide without an instrument, at room temperature. INSPECTR was developed by co-founder James J. Collins, Ph.D., and colleagues at the Wyss Institute for Biologically Inspired Engineering at Harvard University, and licensed from Harvard's Office of Technology Development. Despite its advanced technologies, Sherlock's goals are elementary: "Making diagnostic testing better, faster, and more affordable." The company was launched in March with $35 million in initial financing, includ- ing a $17.5 million non-dilutive grant from the Open Philanthropy Project and other undisclosed investors. "At Sherlock Biosciences, we aim to disrupt molecular diagnostics with bet- ter, faster, more affordable tests that can target any genetic signature, including infectious diseases and oncol- ogy, as well as non-clinical applications, such as agricultural testing without the need of complex lab instruments, allow- ing for rapid results in virtually any setting," noted Rahul K. Dhanda, company co-founder, president, and CEO. Dhanda is among the diagnostic veterans and scientific trailblazers who co-founded Sherlock. They include CRISPR pioneer Feng Zhang, Ph.D., of The Broad Institute, who chairs Sherlock's scientific advisory board. "We are on the cusp of solving challenges ranging any- where from faster pathogen detection and simpler testing for cancer to improved food safety," Dhanda added. "We envi- sion a world where our products will enable users to make more effective decisions wherever results are needed." B eing the mother of a son with autism spectrum dis- order (ASD), Stemina Biomarker Discovery CEO Elizabeth L.R. Donley has experienced many of the frus- trations of parents with children on the spectrum—from delays in diagnosis, to searches for effective solutions and treatments. Stemina's NeuroPointDX business unit aims to address the unmet need for earlier diagnosis and more precise treatment of ASD, with which 1 in 59 U.S. chil- dren are diagnosed. "We are identifying children as young as 18 months for earlier intervention with behavioral therapy and devel- oping paired therapies to treat the metabolic imbalances we see in children with ASD," said Donley. "Some of these will be supplements or medical foods, and others will be targets for new drugs—or additional indications for existing drugs—all based on the underlying metabolic differences of the child with ASD." Donley said the NeuroPointDX ASD test can identify about 30 percent of children with ASD with an increased risk of the disorder. Using proprietary analytical methods, the company has created tests to identify unique subtypes of metabolism in children with ASD. In a study published February 15 in the journal Biological Psychiatry, the company identified some of these subtypes, which are associated with dysregulation of amino acids and branched-chain amino acids. The study offered the first results from the NIH-funded Children's Autism Metabolome Project (CAMP), the larg- est clinical study of the metabolism of children with ASD. CAMP is a large-scale effort to define autism biomarkers based on metabolomic analyses of blood samples from 1,100 children ages 18 to 48 months. "The size and design of this study is the first of its kind calculated to identify differences in metabolism in children in subtypes as small as 5 percent of the ASD cases," Don- ley said. "Metabolism-based stratification of ASD offers the potential for earlier diagnosis and more precise interven- tions based on the child's own metabolism." ELIZABETH L.R. DONLEY CEO, Stemina Biomarker Discovery/ NeuroPointDX RAHUL K. DHANDA Co-founder, president and CEO, Sherlock theasis / E+ / Getty Images

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