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With C. Auris Proliferating, NYSDOH Wadsworth Center to Fund Device Development for POC Tests


NEW YORK – For the first time in its history, the New York State Department of Health's Wadsworth Center will fund the development of diagnostic testing systems. The center issued a request for proposals earlier this year, specifically for point-of-care systems to detect Candida auris, with a submission deadline of October 3, 2019.

The center will choose three applications to fund, with each receiving an 18-month award for $250,000, Wadsworth Center Director Jill Taylor noted in an email.

"This is the first time we are aware of a state public health laboratory actually investing to support the development of screening and diagnostic devices that public health needs," Taylor said. "If successful, it will be a clear demonstration of the value of public-private partnerships in achieving public health goals," she added.

C. auris infections are on the rise. Surveillance by state public health labs detected seven cases of C. auris in the US between 2013 and 2016. That number has exploded in the past three years, with the 2019 national clinical case count including 799 cases in 12 states, and nearly 90 percent of cases occurring in New York, New Jersey, and Illinois.

In New York State, as of this week there have been 393 clinical cases and 574 screening cases reported to the NYSDOH, according to its website.

The US Centers for Disease Control and Prevention also reports that an additional 1,540 patients have been found to be colonized with C. auris by targeted screening in the 12 states with clinical cases as of late July this year.

The yeast was first isolated in 2009 in the ear canal of a patient in Japan, and recent sequencing studies suggest that multidrug-resistant C. auris emerged independently in multiple regions. Some strains are resistant to common anti-fungal drugs, and in general it is also challenging to eliminate C. auris from healthcare settings using standard cleaning and disinfecting protocols.

Wadsworth scientists often develop and publish tests and also frequently collaborate with industry, but the RFP is a new step for the center.

"This is a new initiative funded by investment funds from our grants management partner, Health Research Incorporated," Taylor explained.

Established in 1953, HRI initially served the research program of Roswell Park Cancer Institute, which at the time was an institution of NYSDOH. The corporation now serves major DOH programs located at the Wadsworth Center, as well as the AIDS Institute, the Office of Health Systems Management, the Center for Community Health, the Center for Environmental Health, the Office of Health Emergency Preparedness, and the Helen Hayes Hospital, according to its website.

The Wadsworth funding is explicitly to develop a new point-of-care test system, rather than a cartridge or assay for an existing system targeting C. auris, Taylor confirmed. For example, companies with near-patient or point-of-care systems like the Cepheid GeneXpert, Binx io, Roche Liat, or Quidel Sofia II test could potentially develop assays or test cartridges containing C. auris targets, but these sorts of projects are not the focus of the funding announcement.

"We believe that the availability of a rapid, highly sensitive, and specific point-of-use assay for Candida auris will allow facilities to screen for the presence of the drug resistant yeast at the time of admission and, when present, quickly institute infection control practices to limit further transmission," Taylor said.

The center sees an urgent public health need for these devices in the field and feels that technology has developed to the point that equivalent performance to larger laboratory-based devices may now be feasible, Taylor said.

"We therefore decided that we should be pro-active. As this is a new approach for the Wadsworth Center and HRI, we are moving in stages and there will certainly be manufacturing and regulatory challenges to be addressed at the appropriate time," she said.

As noted in the RFP, C. auris is an emerging fungal pathogen that presents a serious global health threat. Yet, it has been difficult to identify with standard laboratory methods, in part because it can be misidentified in laboratories unless special technology is deployed.

"The method of fungal identification used in many mycology laboratories is still based on culture, and thus C. auris can be confused with other Candida species," Taylor said, noting that specific methods such as real-time PCR or MALDI-TOF are required to differentiate the yeast.

There are already lab-based tests for C. auris. Bruker's MALDI Biotyper system was recently cleared for C. auris detection, and the GenMark ePlex Blood Culture ID Fungal Pathogens (BCID-FP) multiplex panel contains a C. auris target. In addition, researchers at Rutgers University have been developing a C. auris assay, and T2 Biosystems is reportedly collaborating with CDC on an investigational-use-only T2Candida panel for detection of C. auris in US hospitals.

However, real-time PCR can potentially be done directly on patient swabs while MALDI-TOF requires prior culture to first produce a colony, Taylor noted.

Wadsworth has also created qPCR-based lab-developed tests for C. auris, specifically a manual method as well as an automated method using the BD Max, that were published in 2018 and 2019 respectively.

The three successful applicants will work closely with the mycology laboratory at the Wadsworth Center to evaluate and optimize the point-of-use diagnostic device, Taylor said. "We believe that the development of devices such as this will have a huge impact on the ability of public health to mitigate the impact of infectious diseases," she said, adding, "If this initiative is successful, we hope to fund and co-develop point-of-use devices in other areas."

The center is keeping an open mind about what technologies can be used — things such as a POC molecular diagnostic device or an immunoassay with an automated reader could work, in theory — but the submitted devices need to meet certain criteria.

The projects will be scored on their significance, innovation, and approach, with consideration given for the experience of the investigators and the environment the work will be performed in.

In terms of innovation, Wadsworth will assess whether the applications "challenge and seek to shift current clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions," according to the RFP.

Taylor said the successful applicants will negotiate an agreement on ownership and intellectual property with HRI when the funding contract is awarded.