Quick Bacterial Blood Detection Gains Breakthrough Tag

(Public Domain Pictures/Pixabay)

15 March 2018. A technology that detects dangerous bacteria in patients’ blood samples in less than an hour received a breakthrough medical device designation from the U.S. Food and Drug Administration. The technology, known as Biospectrix, is made by 3i Diagnostics Inc. in Germantown, Maryland, which announced the breakthrough status.

The Biospectrix technology aims to provide physicians with a way of identifying bacterial infections in blood much faster than today, which 3i Diagnostics says can take up to 6 days. Much of that time, says the company, is for culturing of blood samples. Other non-culturing analytical methods require anywhere from 6 to 24 hours. Faster results are needed, says 3i Diagnostics, for a correct diagnosis and to prescribe the precise antibiotic needed. While chemical analysis can also return fast results, the technique destroys blood cells and bacteria in the samples, making them unusable for further testing.

The company says its technology employs a microfluidics chip with tiny channels and reservoirs etched into plastic tags that capture the sample of whole blood. Biospectrix then uses inertial forces to separate blood cells by size. After this separation, blood cells are forced through a nanoscale filter that breaks down the blood cells into fragments smaller than bacteria, or other microbes, allowing the microbes to collect unharmed.

At that point, blood cell debris is then removed with another filtering process, and excess water taken out to leave concentrated microbes on a surface made transparent for infrared examination. Infrared is used to perform a spectrometry analysis where the absorption of rays by the captured microbes form unique molecular signatures. 3i Diagnostics says with these signatures, its technology can identify a broad range of bacteria, without making prior guesses or assumptions.

The company says its Biospectrix technology can increase the survival rate for dangerous sepsis infections to more than 80 percent from the current 30 percent, as well as reduce unnecessary prescriptions for antibiotics that feeds the problem of resistance to these drugs.

A breakthrough device is a relatively new designation by FDA, authorized under the 21st Century Cures Act, and begun by FDA in December 2017, which builds on the previous accelerated review process called Expedited Access Pathway. It seeks to reward new devices that offer meaningful advantages over currently cleared technologies, addressing unmet medical needs, and where no other current alternatives exist. Breakthrough devices are given higher priority and more attention from FDA staff to reduce the time needed for agency review.

3i Diagnostics is a 5 year-old enterprise founded by chemical engineer Rajesh Krishnamurthy, who now serves as the company’s chief technologist. Jim Janicki is 3i Diagnostics’ CEO. In an interview in the online publication GenomeWeb published in January, Krishnamurthy and Janicki say the company is raising $5 million to fund further development of its technology.

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