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PositiveID Corporation Publishes White Paper and Data on its Successful Detection of Influenza Virus

PositiveID Corporation, a life sciences company focused on detection and diagnostics, announced that it has published a white paper and data on its successful detection of the influenza virus on its FireflyDX polymerase chain reaction (“PCR”) breadboard prototype pathogen detection system (“prototype system”). The white paper can be found by clicking here.

According to a recent Washington Post article citing federal health officials, this year's flu season is already the most widespread on record, and has already caused the deaths of more children than what normally would be expected at this time of the year. More than 8,900 people have been hospitalized with laboratory-confirmed influenza since the season started October 1.

PositiveID’s FireflyDX prototype system has successfully detected influenza virus. The FireflyDX family of products is designed to provide accurate, rapid pathogen detection at the point-of-care/point-of-need (POC/PON) using real-time PCR in less than 30 minutes, with minimally trained personnel and at a lower cost than existing systems. Current solutions for accurately identifying potential pathogens and bio-threats, especially at the POC/PON, can sometimes take as long as several hours to several days to provide results, dramatically delaying what is often life-saving treatment, while also increasing costs, both personal and financial.

Five different flu virus assays (Type A; Type B; H3N3; H7N1; and, H5N1) were tested on the FireflyDX prototype system; a disposable PCR chip was loaded with the reaction and then inserted onto the FireflyDX prototype system, and the automated runs successfully synthesized cDNA using a reverse transcriptase step and then completed a 40-cycle PCR to produce the detected target results.

PositiveID and its ExcitePCR subsidiary are developing FireflyDX, in both portable and handheld forms, to enable accurate, fast, safe, cost-effective diagnosis in the field, which may offer a highly disruptive breakthrough in combatting influenza, which is often diagnosed with a rapid influenza detection test (“RIDT”). RIDTs are not as accurate, however, as lab-based testing such as PCR. In fact, the CDC recommends that if an important clinical decision is affected by a flu test result, the RIDT result should be confirmed by a molecular assay such as PCR.

“According to the CDC, this year’s flu season is geographically widespread and patients’ health complications are abnormally high,” stated William J. Caragol, Chairman and CEO of PositiveID.  “Unfortunately, as is often the case, because lab-based testing demands both significant time and financial resources, many people being tested at the point of care or point of need with rapid influenza detection tests are getting results that are only partially accurate, or worse, not accurate at all. This may allow the flu epidemic to worsen. Fast, affordable point-of-need diagnostics should be the first line of defense, and we are developing our technology to offer just such a solution,” continued Caragol.

The predominant influenza strain this year is H3N2, which experts believe can present serious health complications. It adapts quickly to vaccines and immune responses and often leads serious outbreaks of the two influenza A viruses and two types of influenza B viruses. Seasons when the H3N2 strain dominates are associated with high levels of hospitalizations, deaths and illness.

In addition to influenza virus, the FireflyDX prototype system has also successfully detected a number of other pathogenic organisms including Zika, Ebola, E. coli, influenza, MRSA, MSSA, C. diff and others.

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