September 1, 2016 (Vol. 36, No. 15)

Gail Dutton

A Microfluidic Device from Fluid-Screen Provides Gold-Standard Results in 30 Minutes

Fluid-Screen, a start-up company that intends to commercialize Yale University research, 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 generates 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 spectroscopy 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 potentially 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 environmental 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 Engineering and Applied Science. Weber began co-developing the technology in 2009 when she was still a graduate student. (Weber ultimately 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 TechConnect-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.


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.

How It Works

Fluid-Screen technology is composed of a microfluidics chip and a reader. The sterile, disposable microfluidics chip separates bacteria from fluid, and concentrates it using dielectrophoresis. This chip is plugged into a reusable, handheld electronic processor that uses functionalized nanowire sensors to identify bacteria based upon its affinity to specific antibodies. The sensor also detects the bacteria’s condition (dead or alive) and number of bacteria in the sample. Data is transmitted by Bluetooth or WiFi to a desktop or mobile device.

Fluid-Screen technology, says Weber, can identify a range of bacterial targets to “capture the broad spectrum of pathogen.” It is especially beneficial in identifying not only Escherichia coli, but also Mycoplasma, Legionella, and other bacteria for which false-positives often occur in culture. “We are developing 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 Excel 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 implications for quality assurance testing. “Fast, accurate bacterial testing means that each product batch can be assayed before it leaves the manufacturing facility or compounding laboratory, thus reducing the need for recalls, risks to patients, liability risks, and reputational damage, each of which far exceeds the consequences of losing a batch of product,” Weber points out.

Water testing offers another application, letting pharmaceutical and food manufacturers identify contamination events throughout the production cycle early, enabling targeted shutdowns of the production process and thus limiting the spread of contamination. Environmental 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 accurately detect bacterial infections in bodily fluids and thereby develop more accurate diagnoses unaffected by the false-positive results that plague some testing methods (such as dip-stick testing for bacterial urinary tract infections). With faster, more reliable diagnoses, 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 developed for the medical diagnostics market.

Although no guarantee of business success, the large number of wins and high-level finishes does suggest Fluid-Screen has a commanding, and potentially disruptive, technology and a well-conceived business plan that can take the product through manufacturing and commercialization. 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.


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 system that delivers results within 30 minutes of sample collection for quality assurance, manufacturing, clinical, point-of-care, and other applications.



























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