Genetic Engineering & Biotechnology News

SEP1 2016

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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Genetic Engineering & Biotechnology News | GENengnews.com | SEPTEMBER 1, 2016 | 11 tibodies. The sensor also detects the bacteria's condition (dead or alive) and number of bacte- ria in the sample. Data is transmitted by Blue- tooth or WiFi to a desktop or mobile device. Fluid-Screen technology, says Weber, can identify a range of bacterial targets to "cap- ture the broad spectrum of pathogen." It is especially beneficial in identifying not only Escherichia coli, but also Mycoplasma, Le- gionella, and other bacteria for which false- positives often occur in culture. "We are de- veloping a chip that will test for multiple types of bacteria simultaneously," Weber asserts. "It's at the prototype stage now. We expect to release it in about two years." Sample analysis is as simple as placing the system's intake tube in the sample for in-device separation and analysis. Because no special training is needed, the test, Weber insists, can "overcome human error." Results are available within 30 minutes. Because analysis occurs on site, errors that may occur during handoffs and transportation to offsite labs are eliminated. Currently, results are analyzed using Ex- cel or other business software. Eventually, Fluid-Screen plans to develop software tools to streamline reporting. Multiple Industry Applications Fluid-Screen technology may be used in any industry for which bacterial contamination is a concern. "We decided to work with pharma first, because the requirements for sterility are the most rigorous," notes Weber. Then, based on those results, Fluid-Screen plans to expand into food, water, and healthcare applications. To see the potential, consider the impli- cations for quality assurance testing. "Fast, accurate bacterial testing means that each product batch can be assayed before it leaves the manufacturing facility or compound- ing laboratory, thus reducing the need for recalls, risks to patients, liability risks, and reputational damage, each of which far ex- ceeds the consequences of losing a batch of product," Weber points out. Water testing offers another application, letting pharmaceutical and food manufactur- ers identify contamination events throughout the production cycle early, enabling targeted shutdowns of the production process and thus limiting the spread of contamination. Envi- ronmental applications include testing storm- runoff to ensure recreational waters are safe. In the clinic, Fluid-Screen's use as a point- of-care assay lets physicians quickly and ac- curately detect bacterial infections in bodily fluids and thereby develop more accurate diagnoses unaffected by the false-positive re- sults that plague some testing methods (such as dip-stick testing for bacterial urinary tract infections). With faster, more reliable diagno- ses, physicians can prescribe specific, rather than broad spectrum, antibiotics, thus easing the pressures that contribute to the growing antibiotic resistance problem. "We believe this is a life-saving technology," states Weber. Fluid-Screen Looks Forward Weber estimates potential U.S. markets at $1.4 billion for pharmaceutical applications and at $5 billion for water testing. She expects that the technology will eventually be devel- oped for the medical diagnostics market. Although no guarantee of business success, the large number of wins and high-level finish- es does suggest Fluid-Screen has a command- ing, and potentially disruptive, technology and a well-conceived business plan that can take the product through manufacturing and com- mercialization. With pilot projects underway, Weber says that she is looking forward to the next phases of development. She is already is talking with global manufacturers. © 2015 Cell Signaling Technology, Inc. Cell Signaling Technology, CST, PTMScan, and SimpeChIP are trademarks of Cell Signaling Technology, Inc. 15PADEPIGNONE0079ENG_00 For Research Use Only. Not For Use In Diagnostic Procedures. © 2016 Cell Signaling Technology, Inc. Cell Signaling Technology, CellSimple, and CST are trademarks of Cell Signaling Technology, Inc. 16PADCSCA0041ENG Visit our website for more information or to download a brochure. www.cellsignal.com/cellsimple CELL SIGNALING TECHNOLOGY Fast. Simple. Powerful. Aff ordable. Portable. CORPORATE PROFILE Fluid-Screen Location Lab Central 700 Main Street Cambridge, MA, 02139 Phone (203) 654-9627 Website www.fluid-screen.com Principal Monika Weber CEO Number of Employees 7 Focus Fluid-Screen has developed a hand-held bacterial detection sys- tem that delivers results within 30 minutes of sample collection for quality assurance, manufacturing, clinical, point-of-care, and other applications. Vital Signs

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