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QuanDx to Distribute Zeesan's High-Risk HPV Genotyping Assay in Europe

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NEW YORK (GenomeWeb) – QuanDx, a San Francisco-based biotechnology firm focused on personalized cancer diagnostics, has announced a worldwide distribution agreement with Zeesan Biotech for that firm's MeltPro High Risk HPV Genotyping Assay. The deal excludes China, and terms of the agreement were not disclosed.

CE-marked last month, the test is a single-tube assay to detect 14 types of HPV. It uses multiplex qPCR followed by multicolor melt curve analysis and is provided as a dry reagent that can be stored at room temperature. The test, which was described in a Journal of Clinical Microbiology study in 2013, can also be run on any thermal cycler.

The Melt-Pro test uses probe-based melting curve analysis, rather than QuanDx's previously described Yin-Yang probes, CEO Matthew Lei told GenomeWeb.

It can also "easily identify co-infected samples" that harbor more than one type of HPV, which are often missed by assays that only detect a few major types of the cervical cancer-causing virus, Lei noted.

Xiamen, China-based Zeesan previously developed a multiplex qPCR test kit to identify 30 leukemic fusion genes, called Q-fusion, which was co-developed and marketed in partnership with QuanDx. That test was CE-marked in June of this year.

Zeesan's melt curve-based tuberculosis drug-resistance test was the subject of a recent clinical evaluation, as previously reported by GenomeWeb, and the firm has also developed a test for non-deletional alpha-thalassemia mutations and an assay for beta-thalassemia genotyping.

QuanDx, meanwhile, raised $1.25 million in a Series B financing round in March, and uptake of Q-fusion "has been going well since we launched ... four months ago, [and] we will continue to our promotion in European countries," Lei said.

In the US, there has been recent debate over using HPV testing alone as a cervical cancer screen, with one economic model suggesting co-testing using an HPV assay plus a Pap test might be more effective. The Roche Cobas HPV test, however, was cleared by the US Food and Drug Administration to be used as a stand-alone screening assay, and that firm was recently awarded a five-year contract from the Netherlands to replace Pap testing there.

There has also been some discussion in the scientific literature regarding the benefit of extensive genotyping for high-risk strains of HPV.

"We think we bring more information about the HPV subtype to doctors, who will make better diagnostic and treatment decisions," Lei said.

QuanDx will now market the HPV test in European countries, and will promote it through its own channels and with distributors in Europe.

"We will continue to focus on developing [tests for] detection of infectious diseases and oncology, such as lung cancer. We plan to go through the FDA next year for those assays," Lei said.  He also noted that the firms are in the process of publishing more scientific papers in the coming months. 

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