Kalorama: IVD Companies Confront Zika Challenge with New Tests at AACC 2016

NEW YORK, Aug. 8, 2016 /PRNewswire/ -- The American Association for Clinical Chemistry (AACC) Annual Meeting and Clinical Lab Expo, which took place August 1–4 in Philadelphia, Pennsylvania, featured many companies vying to produce tests for the Zika virus, according to Kalorama Information.  The virus, for which there is currently no vaccine or medicine, is rapidly spreading in South and Central America, transmitted mostly by the bite of an infected Aedes species mosquito (Ae. aegypti and Ae. albopictus).  Zika can be passed from a pregnant woman to her fetus and infection during pregnancy can cause certain birth defects. The healthcare market research firm's report, The World Market for Infectious Disease Diagnostic Tests, contains detailed market estimates and forecasts for major areas of infectious disease testing

Among the companies currently working to produce U.S. Food and Drug Administration (FDA) approved and CE Marked (free marketability in the European Economic Area) tests for the Zika virus are Hologic/Grifols, Quest, Roche, Thermo Fisher Scientific, Artron Labs, and Primerdesign.

"Infectious disease testing is one of the most dynamic spaces in the in vitro diagnostics industry," said Bruce Carlson, Publisher of Kalorama Information.  "With respect to Zika virus, the FDA has encouraged commercial diagnostic developers and researchers developing laboratory developed tests to submit Emergency Use Authorization requests."

The intensive efforts underway include the following:

• In June, Hologic and Grifols announced that the FDA approved use of the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) study protocol. The assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in serum and plasma specimens. This allows U.S. blood centers to use the Procleix Zika virus assay to screen donated blood collected in potential endemic areas of the southern U.S., and may expand testing to other areas of the U.S. if the virus continues to spread.
• In April, Quest Diagnostics received a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The test was developed by the reference laboratory business of Quest's Focus Diagnostics, Inc., subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, in May 2016.  This test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the United States, including in Toa Baja, Puerto Rico.
• In March, Roche announced that the U.S. FDA provided approval to initiate collection and testing of blood samples for screening with the cobas Zika assay under an Investigational New Drug Application (IND) protocol.  The cobas Zika test for use with the cobas® 6800/8800 Systems, is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors.
• In February, Thermo Fisher Scientific announced the U.S. availability of the EUROIMMUN (Luebeck, Germany) Anti-Zika Virus ELISA and indirect immunofluorescence (IFA) test formats in the U.S. to enable serological detection of the Zika virus in research applications. The kits can differentiate between Zika, dengue and chikungunya viruses. These tests also enable researchers to detect the virus in samples over a much longer period of time than is possible with current direct-detection assays.  The tests allow researchers to detect specific antibodies (IgM and IgG) in blood samples. The EUROIMMUN antibody detection test kits can be run on fully automated analyzers, allowing researchers to work with large volumes of samples to better understand the virus.          
• Artron Lab's One Step Zika IgG/IgM Antibody Test detects for the presence of antibodies against the Zika virus.
• The UK-based Primerdesign team has accelerated their molecular Zika virus detection kit into a CE-IVD marking program.  The kit is available for Research Use Only (RUO) now and should be available in a CE-IVD format in the first quarter of 2017.  

In the US, the FDA stands ready to work interactively with medical product developers to clarify regulatory and data requirements necessary to move products forward in development as quickly as possible.

The World Market for Infectious Disease Tests contains detailed market estimates and forecasts for identification and antibiotic susceptibility testing, immunoassays, molecular testing and blood screening. POC and home testing markets for infectious disease are also provided. Specific market details provided include ID/AST test market by type (Auto ID/AST Systems, Manual ID/AST Systems, Blood Culture, Chromogenic Media, Rapid Micro), infectious disease ID/AST sales by region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020), ID/AST leader market shares, infectious disease immunoassays by type (lab-based, POC, home testing), laboratory infectious disease immunoassays sales by disease (Hepatitis, HIV, Mycology, Parasitology, Respiratory, Sepsis, Sexually Transmitted Diseases, ToRCH, Others), infectious disease immunoassay sales by region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020), infectious disease immunoassays market share, infectious disease molecular sales by region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020), infectious disease blood screening sales by type – Immunoassays/NAT, infectious disease blood screening sales by region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020), and infectious disease blood screening test market shares.

Infectious diseases are also the frequent target of novel technology applications including PCR-alternative molecular amplification methods, next-generation sequencing (NGS), microarrays, and mass spectrometry. Advancements in instrument automated analysis and microfluidics have allowed for the proliferation of infectious disease testing across settings and institutions – from traditional sites such as reference labs through physician office laboratories (POLs) and mobile clinics in the developing world. 

Sales and forecasts of infectious disease reagents are made through to 2020. Emerging products and markets are described; key players and strategies discussed and competitive trends are analyzed.

The World Market for Infectious Disease Diagnostic Tests can be found at Kalorama Information: http://www.kaloramainformation.com/Infectious-Disease-Diagnostic-9367616/.

About Kalorama Information

Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.  

Contact:
Bruce Carlson
(212) 807-2622
[email protected]
www.KaloramaInformation.com

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