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NeoGenomics to Standardize Diagnostic, Drug Development Across US and Europe With Swiss Lab

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 NEW YORK (360Dx)- With a new 8,000 square-foot laboratory in Rolle, Switzerland, NeoGenomics plans to precisely replicate the full spectrum of specialty oncology lab services that the company offers through its six labs in the United States.

The goal is to be able to offer pharmaceutical clients who work with NeoGeonomic for cancer drug and diagnostics development a process that is consistent across the US and Europe, executives said.

"Our pharmaceutical sponsors wanted to use the same standard operating procedures, and the same instrumentation in Europe in the United States, so we duplicated our US laboratories in Switzerland. That's the advantage that NeoGenomics has; we can standardize testing across the US and Europe," said Steven Brodie, NeoGenomics vice president of operations.

Through the lab in Switzerland, NeoGenomics is equipped to work with pharmaceutical clients from drug discovery, through the different phases of drug development, up to and including the development of companion diagnostics, according to Brodie.

The Rolle lab will offer immunohistochemistry, fluorescent in situ hybridization, molecular testing, next-generation sequencing, flow cytometry and cytogenetics, Brodie said. He declined to disclose the financial investment the company has made in the lab.

The Rolle lab currently has eight employees trained in specialized lab testing, all of whom were European hires from various countries. To ensure that the new team in Rolle runs testing operations identical to the operations in the US, staggered teams from the US labs have flown to Switzerland to train the new hires in how to set up equipment, run assays, and run the lab in a manner consistent with NeoGenomics' standards and practices, Brodie said. The team in Europe has regular meetings with US team leaders over the phone and through web conferences.

In addition, NeoGenomics has arranged to have the Rolle lab inspected by the College of American Pathologists to achieve CAP accreditation requirements. "We are meeting the standards of Europe, and at the same time we are meeting the standards of the United States," Brodie said.

The goal is to have the procedures in the US and Europe so closely aligned that if the beginning stages of drug and diagnostics development began in the US, the Rolle lab could leverage that early-stage work and build on it with Phase 2 or Phase 3 studies of European patients, according to Brodie.

"We have these standard operating procedures so if we already started a study in the US, we will just transfer it. ... We send the paperwork over there, have them do a validation of it off what we already have, and that's how they can start working," Brodie said. "Anything we have done here — all the paperwork we have done here and all the regulations that we need here — we also need there. There is a lot of collaboration between multiple teams."

NeoGenomics chose the site in Rolle because of its close proximity to Geneva airport, which is important for transporting and ensuring the stability of samples.

"For certain types of tests, some samples have stability issues. You can't draw a sample in Germany and get it to the US and still have a stable sample. That's why pharmaceutical companies wanted us to have a lab in Europe. If a sample is coming in from Germany, it's going to get to Switzerland much, much quicker. If we have a lab there, we can test a sample while it's still stable," Brodie said. "It's easy to get a sample from New York to Florida. The same goes for getting something from Germany to Switzerland, or Italy to Switzerland."

The Rolle lab is expected to get samples from multiple countries in Europe, Brodie said. The pharmaceutical companies are the ones working with doctors who have patients they want to put on certain regimens, he noted, so where patient samples come from will depend on which patient populations pharmaceutical companies are interested in testing.

The lab, which had its official opening on November 8, has already begun client work in the facility, Brodie said. He declined to name clients the lab was working with. Several drug firms have their headquarters in Switzerland, including Novartis, Huffman-La Roche, Turing Pharmaceuticals, and Debiopharm.

In addition, to proximity to the airport, the Rolle facility is situated between academic centers in Geneva and Lausanne, the company noted in announcing the lab. The lab hopes to develop professional relationships with the medical schools in those academic centers, Brodie said. However he noted that NeoGenomics has no immediate plans to perform diagnostic testing as a clinical service in Europe.

The lab took approximately a year to establish in Rolle, Brodie said. Much of the delay was due to hiring procedures in Europe, where employees may be required to give three months' notice to employers before leaving their positions. The technical experts in the lab were all hired from Europe, Brodie said.

"We want a long-term laboratory," he said. "Laboratories really function well when they have a culture where people want to stay and work in a specific location."

The Canton of Baud, in which Rolle is located, provided significant assistance to the company with filing the proper paperwork to establish the laboratory, Brodie said. The company also worked with external consultants for help with hiring and adhering to other required local issues.

Going forward, the lab will keep pace with NeoGenomics' US laboratories in terms of the research and development necessary to adopt new assays and technologies, Brodie said. Through research and development efforts, led by Chief Medical Officer Maher Albitar, the company closely tracks papers to ensure that it can use the latest technology to identify new mutations that are found.

"There is a lot of collaboration with the Rolle personnel," he said. "We make sure the lines of communication are open and everyone is communicating well."