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QuantuMDx, Global Good Partner on POC Cervical Cancer Screening in Low-Resource Settings

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NEW YORK (GenomeWeb) – QuantuMDx and The Global Good Fund have announced a co-development and commercialization agreement for a point-of-care diagnostics platform and assay to detect 13 high-risk oncotypes of the human papillomavirus. The collaboration is aimed at providing an easy-to-use molecular test that can be deployed to remote cervical cancer screening programs in low-resources settings.

Located in Newcastle upon Tyne, UK, QuantuMDx won funding from the Gates Foundation last year to develop its rapid, handheld, point-of-care molecular platform for tuberculosis testing. The system uses a pathogen-concentration step in sample preparation, microfluidics-based nucleic acid amplification, and detection via microwire arrays.

Now, the same system will also be used for HPV test development, QuantuMDx CSO Jonathan O'Halloran said in an interview.

Screening women for cancer-causing HPV infections with molecular testing may save lives, particularly when combined with standard pathology, and testing is increasingly being adopted in high-income countries. However, in low- to middle-income countries (LMICs) the proportion of women who get screened with MDx tests is quite low; as few as 5 percent of eligible women in sub-Saharan Africa are ever tested, according to a white paper related to the QuantuMDx and Global Good project published by Pink Ribbon Red Ribbon, a non-profit focused on women's cancers.

So-called "test-and-treat" interventions are also showing benefits, especially in LMICs. The long times-to-results of pathology-based tests and some commercial molecular assays typically require women to return for a second visit, which can be a challenge in poor and rural areas. Test-and-treat protocols, on the other hand, demand rapid tests, as well as the ability of the test to be used far from the clinical labs situated in more urban areas.

There has also been growing interest and support for using self-collected samples in test-and-treat scenarios, particularly for women who might otherwise not be be amenable to testing and women in low-resource settings. Studies using assays from Cepheid and Roche published last year confirmed that results from self-collected samples were comparable to clinician-collected cervical samples.

Global Good is a collaboration between Bill Gates and Intellectual Ventures, a privately-held invention capital company, and O'Halloran noted that the HPV assay itself will be developed by molecular biologists in the Intellectual Ventures lab in Bellevue, Washington.

O'Halloran said QuantuMDx and Global Good representatives have been meeting for a few years with the aim of developing a joint project. When Global Good presented the idea of cervical cancer screening, it was clear to O'Halloran that there is a great need for tests, but that the price points are incredibly challenging in LMICs and the cost of going through a premarket approval is onerous.

Yet, "I was staggered when I saw the number of women [in LMICs] who die from cervical cancer each year ... It felt like a calling, if that is not too dramatic," O'Halloran said.

Unlike the firm's TB test in development, for which processing sputum samples in a microfluidic device was a hurdle, QuantuMDx had already developed a buffer for vaginal matrix samples for use in a separate project, engendering faster progress, O'Halloran said.

QuantuMDx currently has a "sample-to-microarray" result time of 30 minutes, and plans to make that time shorter, O'Halloran said. The platform will likely cost between $1,500 and $2,000, as reported for the TB assay. Currently the per-test cost for the HPV assay is $5, but O'Halloran said the goal is to push that lower.

"We've come up with some innovative plans for doing integrative disposables manufacture ... If we can get to a cost of under $1, that really opens up molecular testing in low-to-middle income countries like we've never seen," O'Halloran said. If the gamble plays out, the volumes of testing could potentially be akin to inexpensive tests in "the [rapid diagnostic test] or lateral flow test space," he added.

To reach LMIC's, and particularly rural clinics, the partners will rely on previous work by The Gates Foundation, Global Good, and the Clinton Health Initiative that identifies remote clinics and examines ways to distribute and deliver tests there. "We have a pretty widely accepted road map of how to get to these people through [these foundations'] great work," O'Halloran said.

QuantuMDx is now lobbying The Global Fund to add HPV to the list of disease diagnostics it subsidizes. Failing that, health ministries will likely be the purchasers of the test, and QuantuMDx is putting together health economics data to describe the benefits of cervical cancer prevention screening to these potential customers.

The HPV market in high-income countries, and even in urban areas of some LMICs, is quite crowded.  Along with Cepheid and Roche, Qiagen and Hologic offer assays for HPV. Becton Dickinson also has submitted an HPV assay to FDA, and other firms, such as GeneFirst, are developing HPV tests for CE marking. These tend to be higher throughput, require expert users, and have time-to-results that make them less useful for test-and-treat programs, however.

But in terms of low-throughput, POC HPV testing, particularly for LMICs, O'Halloran asserted that the requirements for a system to be battery operated, dust resistant, inexpensive, and easy to use, among other features, have emptied the field of competitors, particularly for the more distal clinics.

The next steps for the collaborators will be translating the assay developed at Global Good onto the QuantuMDx platform, and, eventually, clinical trials.

"We expect some early clinical data to be coming out around the summertime," O'Halloran said. "With the platform already up and running and Global Good doing amazing work in driving the assay development, it's going very well — clearly things are going to hit the treacle a little bit when we come to working in a clinical setup, but we don't foresee too much of an issue," he said.

The firm's expectation is that there will be five prototypes running HPV assays in the field in Africa by the end of Q1, 2018.

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