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Will Molecular Dx Shops Benefit If WHO Releases H5N1 Sequences?

NEW YORK, March 28 (GenomeWeb News) - Will companies developing molecular diagnostics against the H5N1 flu virus benefit if the World Health Organization makes public the roughly 2,300 viral sequences it maintains for a handful of exclusive labs?


The WHO, bending under mounting pressure from several international scientists asking it to release its avian flu database, said it plans to ask its member states to sign a pledge to share virus data.


For some researchers developing molecular diagnostics for the virus, gaining access to the WHO's H5N1 database might help their efforts.. "Microarrays can gather so much information; it's important that we gather the right information and not the spurious information," said David Danley, director of homeland defense programs at CombiMatrix. "That's what [the WHO's] databases offer."


CombiMatrix has developed an H5N1 test that identifies pathogenicity by typing hemagglutin and neuraminidase genes. "We would like to have on our product those genetic markers that reflect pathogenicity in humans," he said.


But determining what those markers are is not possible without more data linking the strains of avian and human H5N1. Specifically, while data on H5N1 strains that have surfaced in humans in Vietnamand Thailandare now in the public domain, more recent information on human cases in Indonesiaand Europeis not. Those and other data are maintained by WHO reference labs.


 "The human data [for these cases] is really missing," said Henry Niman, a biologist with Recombinomics who is studying the H5N1 virus for recombinant strains. Earlier this month, his company publicly asked the WHO to release its H5N1 database.


Niman said that it is not countries but individual labs, designated as WHO reference labs, that are holding back data, and they are doing so for competitive academic reasons. The UK-based Veterinary Laboratories Agency in Weybridge "is holding onto most of the sequences in Europe, including the Iraqi (human) sample," he said. "And Hong Kong is holding onto all the human sequences from Indonesia." 


Meanwhile, the WHO claims that a mixture of countries and labs have requested that the sequence data remain private. There are eight reference labs working on avian flu sequencing, and many are working with samples from countries that have refused to allow the data to be publicized.


"We're not the supervisors [of the reference labs]," WHO spokesperson Daniel Epstein told GenomeWeb News this week. "They serve us but they are independent. In a sense they are doing us a favor." 


Christine McNab, another agency spokesperson, said the purpose of secrecy is "not to keep the virus sequences to ourselves ... [but] to give incentive to countries to share these."


A spokesperson for the UK's Department for Environment, Food and Rural Affairs said that Weybridge would be issuing more information on sequencing "soon," but could not specify when. As for the lab's past practices, he said that "top-line data was made available to the states involved in the outbreak and to the international authorities like the WHO [as soon as possible]."


China, too, is getting ready to release viral samples that have been held for over six months, the Wall Street Journal reported last week.


Both Niman and Steven Salzberg of the Universityof Marylandconsider the pending sequences to be "fundamental" and said they could be released to GenBank immediately if WHO or other funders apply adequate pressure.


But Richard Janeczko, chief science officer of Tm Biosciences, suggested that these data are from first-pass sequences and thus not validated --- and therefore not "fundamental" --- and that the WHO has no business rushing its reference labs to release them.


"I don't want crap data," he said. "I want good data. Sequencing is not error-free. It's surprisingly error-prone. First-pass sequencing gives you something like 85-percent accuracy. I don't think anything is being held back. I think its being validated."


In January, Janeczko's company began marketing its new ID-Tag RVP (Respiratory Viral Panel) test under the Investigational Device Exemption rules as it prepares to file with the agency. The diagnostic is intended to distinguish between 21 respiratory viruses, including respiratory syncitial virus, SARS, parainfluenza, and various influenza viruses.


Janeczko said his company is satisfied with the data currently available. Moreover, he noted that while a new flood of sequences might allow Tm to make its ID-Tag panel "more reliable and up-to-date" --- assuming the company or others validate them --- it could also be something of a set-back for the product's FDA approval. "It's a balancing act between freedom of access and highly regulated safety standards."


But most researchers agreed that, regardless of the commercial implications, putting sequencing data in the public domain is a priority. "The flu community needs to move into the model that the genomics community moved into some years ago of releasing data quickly," said Salzberg. "Releasing the data quickly gives immediate benefits to people doing basic research on the flu, not just pathogenicists but also people doing epidemiological studies."

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