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Commercial Academic Resarchers .pdf


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Related Articles: 2
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Commercial, Academic Researchers
Race To Develop Zika Tests
By Sue Darcey / Email the Author / View Full Issue
Top Stories / Word Count: 1062 / Article # 01160208012 / Posted: February
3 2016 10:00 PM

Executive Summary
Academic researchers supported by National Institutes of Health grants and
several commercial diagnostic firms say they have already developed, or
have almost completed work on, new Zika virus diagnostics. Meanwhile,
congressional leaders are pressing HHS to expedite response efforts.

At least two academic researchers supported by National Institute of Allergy and
Infectious Disease grants have developed assays for rapid detection of Zika and
related viruses, NIAID told “The Gray Sheet." The assays are being validated as
leaders in Congress call for hearings on Zika and press government agencies to
hasten the response to spread of the virus.

Senate HELP Advances Device
Review Reform Bills
“The Gray Sheet” Feb. 9, 2016
Zika Virus Rapid Diagnostics
Sought By NIH As MosquitoBorne Malady Spreads
“The Gray Sheet” Jan. 27, 2016

Topics Covered in
this Article
Click a keyword for related
articles.
Subjects
Regulatory
Industries
In Vitro Diagnostics
Molecular Diagnostics
Point-Of Care
Medical Devices
Regions
Latin America

Also, at least four companies – GenArraytion Inc., Rockville, Md., Biocan
Diagnostics Inc., in Canada; MyBioSource in San Diego, Calif., and Genekam
Biotechnology AG in Duisberg, Germany – have developed tests. BioCan’s and
Genekam’s assays are already being used on an experimental, emergency-basis in
Brazil, according to the firms.
Zika virus is a mosquito-borne illness linked to birth defects that is spreading in
Latin America and has also shown up in individuals in the US. (See "Zika Virus
Rapid Diagnostics Sought By NIH As Mosquito-Borne Malady Spreads" — "The
Gray Sheet," Jan. 27, 2016.)

NIAID-Supported Assays
Eva Harris, University of California, Berkeley, and Ian Lipkin, Columbia University,
have each developed reverse transcription polymerase chain reaction (RT-PCR)

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2/12/2016

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assays enabling rapid detection of all dengue virus strains, as well as Chikungunya
and Zika viruses with NIAID funding, an agency spokesperson said Feb. 1.
NIAID stressed the importance of
detecting the related flaviviral strains that
cause similar symptoms to Zika during
acute infection. Current serologic tests
are unable to reliably differentiate
between prior exposures to Zika
flaviviruses, the agency noted.
“Addressing this need will require the
development of improved serologic tests
that eliminate cross-reactivity with other
flaviviruses,” NIAID told “The Gray Sheet”.

“Addressing this need will
require the development of
improved serologic tests
that eliminate crossreactivity with other
flaviviruses,” a NIAID
spokesperson said.

The agency, which works under the umbrella of the National Institutes of Health,
also has a “Centers of Excellence for Translational Research” program to create a
new diagnostic program, the VirCapSeq-vert, that Columbia's Lipkin is developing
to characterize the complete coding sequence of all vertebrate viruses with the
same sensitivity as real-time PCR.
NIAID calls the technology “promising" to facilitate detailed tracking of virus
evolution and provide clinically relevant information about pathogen susceptibility to
vaccine and drug interventions. Through NIAID support, the VirCapSeq-vert
platform is being validated for Zika virus.
NIAID is encouraging any interested commercial test companies to develop
sensitive, specific and rapid clinical diagnostics for the identification of Zika and
other viral pathogens carried by mosquitos such as the dengue, yellow fever and
Chikungunya viruses.

Commercial Test Status
GenArraytion has developed a PCR-based molecular test, the
GenArraytionMultiFLEX Bioassay,that can identify four distinct regions of Zika virus,
as well as the Chikungunya virus, the yellow fever virus, four types of dengue virus,
West Nile virus and Plasmodium falciparum. The firm's CEO, R. Paul Schaudies
added that the test is also being developed for real-time PCR platforms.
The company “has been in communication with officials at the FDA and [we] have
provided them with data from our Luminex-based” assay, Schaudies told “The Gray
Sheet” Feb. 3.
He added that the agency postponed a meeting for this week until they determine
the emergency use authorization status of the test.
Biocan Diagnostics told “The Gray Sheet” that its Zika/Dengue/ChikungunyaCombo
Rapid test can simultaneously detect and differentiate between IgG and IgM
antibodies to Zika virus and Chikungunya virus in human serum, via a finger-prick
sample. The combo test can also distinguish between the IgG and IgM antibodies,
plus the NS1 Antigen, to the dengue virus, according to Biocan Vice President
Bahavjit Jauhar. Clinicians, in addition to seeking tests that can differentiate

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between the three viruses, also “would like to see if patients can be co-infected with
Zika, dengue or Chikungunya infection,” he said.
“Brazil has been using it for research purposes,” Jauhar noted in a Jan. 27
interview, and added that Biocan, which is located in Coquitlam, B.C., Canada,
intends to file for clearance of the diagnostic in Canada first and other countries
later. “We are also looking into FDA clearance right now,” the VP added.
Genekam Biotechnology announced in January that it has developed a ready-touse PCR kit to detect the Zika virus in mosquitoes and human samples. The
specificity of the kit has been tested with related viruses like dengue, yellow fever,
West Nile virus and other arthropod flaviviruses, the company said in a Jan. 18
release.
However, a Genekam researcher told Reuters Jan. 30 that the tests can only be
administered in specialized medical facilities and laboratories with the appropriate
equipment and training.
A batch of the Genekam kits has already been sent to Brazil for immediate use; the
government waived the usual authorization process because of the rapid spread of
Zika, according to Reuters.
A fourth company, MyBioSource, is offering a series of Zika virus test kits for use by
researchers worldwide. These include the ZIKV virus RT-PCR Kit, which detects
Zika virus in serum and plasma, and the ZIKV IgM Elisa (enzyme-linked
immunosorbent assay) Kit and ZIKV IgG ELISA Kit, which detect IgM and IgG
antibodies, respectively, in serum or plasma.

Lawmakers Call For Hearings
Both Senate HELP Chairman Lamar Alexander, R-Tenn., and Ranking Member
Patty Murray, D-Wash., are pressing relevant agencies including FDA, NIH and
NIAID, the Centers for Disease Control and Prevention for more information about
new diagnostic test and vaccine development to address the growing spread of the
Zika virus.
Pointing to a recent World Health Organization announcement that Zika-linked
conditions constitute a public health concern, Sen. Alexander called on the HHS
agencies “to ensure that our nation is as prepared as possible for this and other
emerging health threats.” This includes leveraging the tools HHS has at its disposal,
to rapidly advance R&D into Zika diagnostics and therapeutics, Alexander stated in
a Feb. 3 letter
to HHS Secretary Sylvia Mathews Burwell.
On Jan. 29, Alexander announced the committee’s plans to hold a hearing in the
near future on the Zika virus, and Sen. Murray told HHS in a correspondence
,
“HHS must accelerate work on effective diagnostics, treatments and preventative
vaccines.”
The House Energy and Commerce Committee is also seeking a briefing with HHS
officials at NIH and CDC, and sent letters
to several agency heads asking a
series of questions about what is known about the virus.
This copy is for your personal, non-commercial use. For high-quality copies or
electronic reprints for distribution to colleagues or customers, click here or call

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