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10 | SEPTEMBER 1, 2016 | GENengnews.com | Genetic Engineering & Biotechnology News Gail Dutton Fluid-Screen, a start-up company that in- tends to commercialize Yale University re- search, is developing a quality assurance test for bacteria. The test can deliver results within 30 minutes, rather than the 24 to 48 hours other assays need to grow cultures and deliver results. The test not only gen- erates results in short order, it also offers handheld convenience and a high degree of accuracy. By making such a test available, Fluid-Screen hopes to shake up the bacterial testing industry. "Results are comparable to those of standard culturing followed by polymerase chain reaction (PCR) or mass spectrosco- py analysis, but much, much faster," says Monika Weber, Fluid-Screen's founder and CEO. Speed is the main advantage of the company's newly developed methodology, which Fluid-Screen describes as being po- tentially disruptive. Like the gold standard of bacteria testing methodologies, Fluid- Screen's handheld device offers better than 99% positive identification and is sensitive down to one bacterium per 100 mL of fluid. It also identifies the type of bacteria present in the sample and differentiates between live and dead bacteria. The Fluid-Screen technology currently is in the research phase of development. "We have three ongoing pilots," Weber indicates. Two are underway at major pharmaceutical companies. The other focuses on environ- mental applications and is being conducted with a grant from the Massachusetts Clean Energy Center to test water at beaches, lakes, and rivers to determine whether they are safe for recreational purposes. The technology was spun out of Yale University's Reed Lab in the School of En- gineering and Applied Science. Weber began co-developing the technology in 2009 when she was still a graduate student. (Weber ul- timately secured a master of engineering in microelectronics.) Although the technology has not yet been released, it has already helped Fluid-Screen garner several awards. In 2016, the company was a National Innovation Awardee at Tech- Connect-Washington DC, and it garnered first place in the M2D2 Becton Dickinson Award this year. In 2015, Fluid-Screen won the TechConnect World National Summit Innovation Award. How It Works Fluid-Screen technology is composed of a microfluidics chip and a reader. The sterile, disposable microfluidics chip separates bacte- ria from fluid, and concentrates it using dielec- trophoresis. This chip is plugged into a reus- able, handheld electronic processor that uses functionalized nanowire sensors to identify bacteria based upon its affinity to specific an- An "in Hand" Assay Is at Hand CORPORATE PROFILE > Illumina and Personal Genome Diagnostics Ink In Vitro Cancer Dx Deal Personal Genome Diagnostics (PGDx) signed an agreement with Illumina to de- velop two in vitro diagnostic test kits for use on Illumina's sequencing instruments, including kits for the detection and charac- terization of tumor DNA using both tissue and plasma samples. "PGDx currently offers advanced genom- ic testing services to researchers, drug devel- opers, and physicians and patients through our CLIA-certified laboratory," said Doug Ward, the company's CEO. "We now want to apply our expertise to the development of IVD test kits for both tissue and plasma- based samples that will enable other labo- ratories with next-generation sequencing capability to benefit from our broad experi- ence in cancer genomic testing." > MilliporeSigma to Provide Y-mAbs wtih wtih Provantage Develop- ment and Manufacturing Services Services MilliporeSigma will provide its Provan- tage® end-to-end development and manu- facturing services to Y-mAbs Therapeutics in support of Y-mAbs' monoclonal antibody in late-stage clinical development. The antibody targets refractory leptomeningeal tumor neuroblastoma and diffuse intrin- sic pontine glioma. Following transfer of Y-mAbs' lead cell line to MilliporeSigma, services will include scale-up and GMP manufacturing of an antibody currently in late stage clinical development. > Rubicon Genomics Licences High-Throughput Small RNA Sequencing Method from SomaGenics SomaGenics signed a licensing agree- ment with Rubicon Genomics for com- mercialization of SomaGenics' RealSeq ® - AC library preparation technology for sequencing small RNAs, including micro- RNAs and small fragments of large RNAs. According to Brian Johnston, Ph.D., president and CEO of SomaGenom- ics, the RealSeq - AC platform reduces sequencing bias compared to standard methods for preparing libraries for small RNA sequencing. > Quanterix and Banyan Biomarkers Collab on Development of Biomarkers for TBI Quanterix eintered into a license agree- ment for research use with Banyan Biomark- ers for the development of biomarkers for traumatic brain injury (TBI). Quanterix's Si- moa platform will incorporate the Banyan UCH-L1™ and Banyan GFAP™ assays to help further neurological research for improved TBI diagnosis and treatment. n News Products & Services A Microfluidic Device from Fluid-Screen Provides Gold-Standard Results in 30 Minutes Stem Cell Science Continued from page 8 First, any manipulation of a harvested tissue (separation of cells from fat or culturing or concentrating bone marrow cells) gives the treatment status as a drug. Second, taking cells from one location (such as fat) and put- ting them into another location, such as the bloodstream, also means that the cells must be regulated as a drug. The FDA has been slow to enforce their oversight of these clinics by any meaningful action, and this regrettably has, if not con- doned, permitted the proliferation of sites offering perceived unregulated stem cell treat- ments. But happily this is changing. At the World Stem Cell Summit in 2015, Robert Califf, M.D., the FDA Commissioner, told the gathering of scientists, clinicians, and patient advocate attendees that the FDA is willing to consider complaints about any specific clinic. There is another opportunity to let the FDA know our opinions. In September, the FDA will hold a public hearing on their proposed changes to regulations of stem cell therapies. 3 This meeting, called "Part 15 Hearing on Draft Guidances Relating to the Regulation of HCT/ Ps [Human Cells, Tissues, and Cellular and Tissue-Based Products]," will be held at the NIH headquarters in Bethesda, MD. There are 54 clinics or organizations scheduled to speak at this meeting and forty individuals. What else can be done? Since the public is the victim of these clinics, anyone invested in the development and implementation of le- gitimate therapies must get involved to curtail these opportunists whose money-making ven- tures not only may be harmful but jeopardize by association the real potential of stem cell research in regenerative medicine. Previous at- tempts to expose such clinics have been if not silenced at least muffled by the threat of legal action. We in turn need to turn to the law to safeguard the future of regenerative medicine. Clinics often make patients sign agreements not to disparage them as a condition of pro- viding the treatment. This makes it difficult for individuals to sue the clinics for failing to pro- vide a therapy that has the positive effects ad- vertised, though there has already been a prec- edent. A product liability lawsuit has been filed against one such U.S. clinic. 4 The high costs of these treatments, from $10,000 to $100,000, should motivate individuals seeking these ther- apies to ask for some guarantee or at least the right to seek recourse in the event of harm or non-provision of goods as promised. The public has a major role to play in the protection of regenerative medicine. After all, who has a greater stake in the responsible advancement of the field? References Available online at GENengnews.com. Fluid-Screen's handheld bacteria assay device is built around a sample chip, a disposable module with a built-in filtration system and biosensor. The sample chip plugs into a reader, a reusable electronic processor that identifies the presence, specific type, and condition of bacteria in the sample. The sample chip's biosensor uses antibodies for bacterial detection and identification. The reader sends data via Bluetooth/WiFi to either a desktop or mobile device.