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With Studies Underway in South America and Asia, QuantuMDx Readies POC Platform for Launch

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NEW YORK (GenomeWeb) – QuantuMDx is working with partners in South America and Asia to trial the use of its platform for human papillomavirus testing in low-resource settings.

The British molecular diagnostics firm also recently completed a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year. Once a CE-IVD marking is achieved, QuantuMDx plans to obtain a separate CE-IVD certification for its HPV assay by mid-2020, according to John Burn, its founder and chairman.

For more than a year, the Newcastle, UK-based firm has been working with the Global Good Fund to develop an assay that can detect high-risk HPV types and is now beginning to trial the test in Peru.

The company has another partnership with St. George's Hospital Medical School at the University of London to trial the same assay in the UK, as well as in Malaysia through a partnership with the University of Malaya in Kuala Lumpur.

Both studies should showcase the ability of QuantuMDx's microfluidics-based, multiplex PCR platform to perform in the setting for which it is intended: lower-income countries.

"These will be our first, genuine, global market projects," said Burn. "If we can demonstrate reliable diagnosis of HPV oncogenic subtypes on a cassette that, at scale, can be manufactured for a few dollars, then it becomes affordable in lower-income countries and deployable globally."

Being able to offer point-of-care molecular diagnostics in the field to women in Peru or Malaysia is in line with QuantuMDx's vision for making its technology available to all. Rather than just serve markets in Europe or North America, the company is currently focused on getting Q-POC and its HPV genotyping assay into low-resource settings where the need for such testing is high.

"The basic problem and it's a global problem is that nine out of 10 cervical cancers are in lower-income countries, where the capacity to do cervical screening is poor and uptake is worse because women in Islamic countries, for example, don't like the idea of having someone examine their cervix, so getting care to those women is very challenging," said Burn.

The World Health Organization reports that cervical cancer is the fourth most frequent cancer affecting women and estimated last year that 570,000 women would be diagnosed with the disease in 2018. According to the WHO, 90 percent of deaths from cervical cancer occur in low- and middle-income countries. The organization has encouraged the creation of better screening tools as a way to address the issue.

"The numbers are horrendous," said Burn. "In Britain, we lose maybe 900 women a year, which is a lot, but globally more than a quarter of a million women will die," he said. Burn noted that about 80 percent of the population worldwide is exposed to HPV. Though most people eradicate the virus, those who do not are at increased risk for developing cervical cancer.

"Ergo, if you want to target your efforts, first of all you have to test if someone is HPV positive," said Burn. "If they are HPV negative then you can probably let them go they are unlikely to die of cervical cancer. But if they are HPV positive, you can focus your healthcare on that smaller group of women who have HPV," he said. "It is a classic example of personalized healthcare."

It is also a market where QuantuMDx believes its point-of-care device could have an impact. While the market for HPV genotyping is served by some of the biggest players in molecular diagnostics, the tests are often performed on conventional PCR instruments, not POC devices.

Last month, for instance, Qiagen achieved a CE-IVD mark for its QiaScreen HPV PCR test, which tests for 15 high-risk genotypes of HPV associated with cervical cancer. The assay is performed on Qiagen's Rotor-Gene Q benchtop MDx platform. Meanwhile, Siemens' Fast Track Diagnostics last year achieved a CE-IVD marking for an assay that detects 14 HPV subtypes in high-risk patients. The test is compatible with most PCR systems on the market. Roche also offers an HPV test that runs on its Cobas 4800 System.

"What we are trying to do is genuinely democratize DNA testing," said Burn. "People talk about spending $700 for this, or $1,200 for that, but in countries where they spend just a few dollars per head per year, that's just never going to be achievable ever," he said. "We have got to get the technology into a form where we can make DNA-based testing feasible for everybody."

Burn, a professor of clinical genetics at Newcastle University, co-founded QuantuMDx in 2008 to commercialize its Q-POC platform and a pipeline of assays targeted to health workers and pharmacists. The company also maintains subsidiaries in Chattanooga, Tennessee and in Singapore, called QuantuMDx US and QuantuMDx Asia, respectively.

QuantuMDx claims its portable device carries out sample preparation, DNA extraction, DNA amplification using continuous flow PCR, and DNA detection from a microwire microarray within 20 minutes. According to the firm, its microwire arrays are spotted with DNA probes complementary to the target DNA markers, and once a sample is flowed over the array, if the targets are present in the sample, hybridization occurs, and fluorescence is therefore detected. QuantuMDx has had a prototype of the device for years, but Burn said the company decided to redesign the system following its most recent fundraising round, when it raised $12 million last year.

"We have had a working device, but after a lot of field testing we realized it wasn't robust enough to cope with all of the situations it would face when you take it out into the field," said Burn. "So, we reengineered the box and it looks a bit squarer now. The cassette goes in the front, not the side, which means you can stack it." he said. "It's more resilient to all situations to altitude, temperature, humidity, et cetera. It's essentially the same machine, just in a different box."

With the redesign accomplished, Burn said the company is now in discussions with manufacturers ahead of achieving a CE-IVD mark for the device. Once that milestone is reached, QuantuMDx may seek more funding as it scales its manufacturing resources for future demand.

"We are now within 12 months of [having a] CE mark, and that will take us to the next level in terms of valuation," said Burn. "We just now need to go to scale in manufacturing."

Performance testing

The first locations where QuantuMDx's Q-POC will be deployed are a long way from the brisk streets of northern England.

QuantuMDx first announced its partnership with the Global Good Fund two years ago, and has worked with the fund, which is backed by Bill Gates and Intellectual Ventures, to develop an assay targeting the 13 high-risk oncotypes of HPV.

According to a QuantuMDx spokesperson, Global Good undertook a performance valuation on a panel of patient samples and presented a poster at the International Papillomavirus Conference in Sydney, Australia, in October, and then again at the European Research Organization on Genital Infection and Neoplasia's annual conference in Lisbon, Portugal, in December.

"We're at performance testing stage, with our partners at St George's as well as with Global Good in South America," noted the spokesperson. "The performance testing is due to start in South America imminently."

Noni Gachuhi, women's health lead at Global Good, confirmed that the initiative has been working with QuantuMDx to develop a cassette-based molecular diagnostic for high-risk HPV infection, and is preparing to test the platform in the field in Peru this year.

"The test is designed to be low-cost, easy to use, and will be able to support same-day screening and treatment programs, which are critical for low-resource health systems," said Gachuhi. She noted the test is also being developed to be compatible with self-collected samples, which should extend the reach of reliable HPV screening to rural and remote areas.

"We will be in Peru as part of the research and development process to support optimization of assay performance," Gachuhi said.

Partnering with companies like QuantuMDx is in line with Global Good's mission to develop technologies for low-resource settings in the areas of healthcare and agriculture, she added. In addition to developing devices for cervical cancer screening, Global Good is also focused on creating tests and tools for diagnosing and managing other diseases like malaria and tuberculosis.

QuantuMDx announced its partnership with St. George's at University College London last month. Under the terms of the agreement, St. George's will trial the HPV assay in high-resource settings in the UK as well as in low-resource settings through its relationship with the University of Malaya.

In October, St. George's signed a memorandum of understanding with partners at the University of Malaya to work together in the areas of cancer, infectious diseases, and point-of-care diagnostics. Researchers at UM are currently spearheading a collaborative trial focused on cervical screening that involves self-sampling of women, HPV DNA testing, a digital e-health platform, and real-time reporting. QuantuMDx is now part of that trial. St. George's is currently testing QuantuMDx's prototype for genotyping HPV in the UK, but plans to expand its study to Malaysia via its partnership with UM later this year.

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