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Calbiotech, Inc. First U.S. Company to Develop, Commercialize Zika Virus Diagnostics
Date:3/31/2016

Calbiotech, Inc., a global leader in immunoassay development, announced today that it has launched two new ELISA kits for the detection of IgG and IgM antibodies against Zika virus in human blood. Calbiotech is the first U.S.-based diagnostic company to develop and commercialize an immunoassay for Zika virus.    

Zika virus is a mosquito-transmitted single stranded flavivirus in the family Flaviviridae. It was initially isolated in 1947 from blood of a rhesus monkey during a yellow fever study in the Zika forest of Uganda. The virus was subsequently isolated from a pool of Aedes mosquitoes, common to tropical and sub-tropical regions around the world, and also known to spread other flaviviruses, such as Dengue, Chikungunya and Yellow Fever.

In April of 2015, Zika virus re-emerged in Brazil and quickly spread to epidemic proportions. Though the true number of Zika cases is unknown, officials estimate between 500,000 and 1.5 million people have contracted the virus in Brazil alone. As of March 2016, Zika had spread to over 40 countries, including 273 cases in the U.S.

Zika virus infection is asymptomatic in many patients, making it very difficult to asses an early diagnosis. When clinical illness does occur, symptoms are usually mild, with exanthematous rash, fever, conjunctivitis or arthralgia. Only 20% of people infected show any of the mentioned symptoms, which last for several days to a week after being stung by an infected mosquito. While those manifestations don’t seem dangerous, the main concern of this disease comes from its transmission from pregnant women to their fetuses.

Several recent studies indicate that Zika virus can cause abnormal development in fetuses, resulting in miscarriage or severe microcephaly, a serious condition in which the baby’s head and brain are severely underdeveloped. Due to the potential link between Zika virus infection and microcephaly, on February 1, 2016, the World Health Organization (WHO) declared a Public Health Emergency of International Concern.

According to the Centers for Disease Control (CDC), there are multiple cases of Zika virus being transmitted from person to person, typically through sexual contact or from mother to child during pregnancy or birth. Both of these scenarios emphasize the importance of an accurate and accessible diagnostic.

Calbiotech’s Zika Virus IgG and Zika Virus IgM ELISA kits can determine if a patient is infected using only 10 microliters of serum or plasma, delivering results in only 50 minutes. These easily automatable tests are highly sensitive to Zika virus and show minimal cross-reactivity to other flaviviruses. Calbiotech is in the application phase for an Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and is currently offering these products for Research Use Only.

Calbiotech’s Vice President, David Barka, led the company’s effort in developing the Zika virus ELISA kits. Barka stated, "I am proud of our team’s collective effort to work quickly and diligently to develop this very important diagnostic tool that will aid doctors and researchers in their efforts to control this outbreak.”

Calbiotech is currently collaborating with partners and government agencies in the U.S. and Brazil to aid in the implementation of these assays. Additionally, Calbiotech is also developing a Zika virus diagnostic based on its proprietary MagCLIA™, magnetic bead platform. The MagCLIA assay will offer enhanced sensitivity and will be compatible with high throughput, automated random access immunoassay analyzers.

Yonas Yohannes, Calbiotech’s Scientific Director, commented, “The Summer Olympics in Brazil, combined with the upcoming mosquito season, may accelerate the spread of Zika virus to a global scale. As the disease spreads, more efficient diagnostics will be needed, which is why we are focusing our efforts on developing a Zika virus assay on our MagCLIA platform to compliment our new Zika virus ELISA products. Although we hope that the spread of Zika virus can be controlled, we will continue our efforts to advance the availability of these critical diagnostics.”

About MagCLIA

Calbiotech has developed Magnetic Bead Assays for Random Access Immunoassay Analyzers. Calbiotech’s full immunoassay menu is available in MagCLIA technology. Calbiotech MagCLIA assays are based on CalMagBeads™ technology, featuring super-paramagnetic beads covalently coupled via an innovative linking technology with recombinant streptavidin for the binding of biotinylated molecules.

About Calbiotech

Founded in 1998, Calbiotech develops, manufactures and distributes immunoassay products, including ELISA and CLIA kits, random access magnetic bead assays, coated microplates, reagents, buffers and other components which are offered to major reference labs, pharmaceutical companies, universities and research centers in the U.S. and to over 80 countries around the world. Calbiotech operates under cGMP and ISO 13485 Standards in an FDA Registered Facility in San Diego, California.

Read the full story at http://www.prweb.com/releases/2016/04/prweb13309170.htm.


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Source: PRWeb
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