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With CE Marked HAI Kit, Pathogenica Looks to Expand Customer Base to ICUs, Physicians

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Last week, Pathogenica announced that it achieved the CE mark under the European Directive on In Vitro Diagnostic Medical Devices for its HAI BioDetection kit, a sequencing-based assay that uses Life Technologies' Ion Torrent PGM to detect 12 pathogenic bacterial species that are responsible for 95 percent of hospital-acquired infections.

With the designation, the company is now able to move from research-use only and into the clinical market. Pathogenica's CEO Adeyemi Adesokan told Clinical Sequencing News that the company will now look to broaden its customer base beyond infection control specialists in hospitals. New potential customers could include intensive care units and physicians.

Adesokan said that the company is considering seeking US Food and Drug Administration 510(k) clearance for the kit, an aim that is "further down the line, but of interest."

The CE mark allows the assay to be used as an in vitro diagnostic in Europe and other countries that recognize the CE mark for marketing purposes. The kit can be used in real time during an outbreak to identify the responsible pathogen and to diagnose patients. Adesokan anticipates that it could have broad utility in hospital intensive care units, especially for patients that are immune compromised and on antibiotics, since the assay also detects drug-resistant genes.

The test "provides a way to detect a number of pathogens … as well as drug-resistant genes, enabling physicians to practice proper antibiotic stewardship," he said.

Additionally, specialists for gastroenterology, urology, pulmonology, and even ear, nose, and throat doctors could also see value in the test for diagnosis, Adesokan said.

As an example of how a specialist could use the test, Joseph Chanpong, COO for Pathogenica, explained to CSN, that "ENT specialists sometimes have patients with challenging infections that they want to diagnose but can't culture." Often, the physician will "reluctantly treat [the patient] with antibiotics."

Chanpong estimated that between five percent and 10 percent of bacterial species are either unculturable or do not yield a definitive result. Culturing can also take several days, versus 12.5 hours to run the HAI BioDetection assay. "So, sequencing is a valuable technology to get an actual result back," he said, which would enable the correct antibiotic to be chosen.

Prior to receiving the CE mark, the company began collaborations with two Dutch hospitals — the University Medical Center Groningen and Amphia Hospital — that are using the kit for surveillance and monitoring of infectious bacteria.

The University Medical Center Groningen is testing the kit in a pilot of active surveillance of common drug-resistant bacteria, while Amphia is using it to assess an outbreak of multi-drug resistant Escherichia coli.

Additionally, the company recently said that it will comarket with Illumina a version of the kit on the MiSeq system in the Asia-Pacific region.

Adesokan declined to comment on future plans to develop an IVD kit for the MiSeq-based assay.

Pathogenica will continue to also sell the research-use only version of its kit, and Adesokan said that the IVD and RUO products would be priced differently, but declined to provide specifics.

The kit is based on proprietary molecular inversion probe technology and targeted sequencing, which the company has dubbed DxSeq. The HAI kit uses 500 probes to target 500 unique regions in 12 different pathogens, encompassing between 5 kilobases and 10 kilobases of sequence. The targets include not only markers that will identify the strains, but also genes that confer resistance to 15 different drugs such as vancomycin and methicillin.

Next-gen sequencing is quickly becoming a tool of choice for monitoring and evaluating outbreaks (CSN 12/19/2012).

The UK-based Modernizing Medical Microbiology Consortium, a research project funded by the UK Department of Health that includes the University of Oxford, the HPA, and the Wellcome Trust Sanger Institute, last year received a four-year grant to conduct research toward implementing sequencing in the public health setting. And researchers at the National Institutes of Health have used whole-genome sequencing to track an outbreak of drug-resistant Klebsiella pneumoniae in real time (CSN 8/22/2012).

While many of these other studies have focused on using whole-genome sequencing, Pathogenica is betting that a targeted kit may see more widespread adoption, particularly among physicians who do not have the bioinformatics expertise to do whole-genome sequencing. A targeted kit also has advantages in cost and turnaround time. The CE mark makes it the only sequencing-based pathogen detection kit, which will enable it to be used in a clinical setting for diagnostic purposes, Adesokan said.

Graeme Doran, the company's chief scientific officer, said that the technology is also "applicable for other bacterial diseases" and said the company is planning additional kits, but did not elaborate.

When Pathogenica first launched, it had planned to develop a human papillomavirus detection kit as its first product, but last year switched to developing the HAI kit after requests from researchers indicated there was a greater need for a kit assessing pathogenic bacteria responsible for such infections (CSN 9/26/2012).

Adesokan said that while the company has demonstrated technical achievement in HPV as well as hepatitis C virus and HIV, Pathogenica decided to prioritize the commercialization of its HAI kit, "rather than expand the number of kits we manufacture." Additionally, he said that "several parties" have expressed interest in licensing those assays, so Pathogenic is "considering those offers as an alternative or supplemental commercial path."

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