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NeoGenomics, PPD Alliance Expected to Boost Oncology Companion Diagnostic Services

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NEW YORK (360Dx) – The strategic alliance announced earlier this month between NeoGenomics and Pharmaceutical Product Development (PPD) is expected to boost the companies' oncology companion diagnostics services by combining NeoGenomics oncology expertise with PPD's global contract research organization services, the companies said.

"The pharma industry is really a global industry and NeoGenomics was just starting to expand outside the US with the opening of its Geneva lab in November 2017," said George Cardoza, president, pharma services, NeoGenomics. "PPD is truly a global CRO, so we are going to work closely with them in Singapore and Shanghai to be able to support global clinical trials."

The two companies have an overlap in customers but often work with different groups across the pharmaceutical spectrum, according to Christopher Fikry, executive vice president of PPD Laboratories. While NeoGenomics is focused on oncology testing, PPD often has business with the same customers in peri-approval and post-approval of drug and diagnostic development in several clinical areas.

"The goal of the alliance is to offer clients the best of both worlds, all of PPD's expertise and systems, and also Neo's strength in oncology testing," Fikry said. "Going forward, all current and potential pharmaceutical clients who require pathology and molecular testing will have a global solution."

By combining PPD's CRO services and NeoGenomics molecular testing menu, the two companies will be able to support pharmaceutical and biotech clients from biomarker selection through clinical trials and regulatory approval and into commercialization, Cardoza and Fikry said.

However, the two companies believe the alliance will be particularly impactful for oncology companion diagnostics. The majority of clinical trials today, particularly in oncology, have a biomarker component to help clinicians identify which patients will gain the most benefit from a given therapy, Cardoza and Fikry said.

NeoGenomics, by itself, was not able to offer the full solution pharmaceutical companies often want with respect to handling a clinical trial from working with sites to logistics to systems. In oncology, however, the company has expertise in developing tests, an extensive molecular testing menu with the ability to develop immunohistochemistry assays, and a channel of pathologists and oncologists it works with daily, through which to sell tests, Cardoza said.

NeoGenomics has more than 30 companion diagnostic studies underway and has been building capabilities in this area, according to Cardoza. The company was one of the first labs to have Agilent Technologies' Dako PD-L1 IHC 22C3 pharmDx assay available from day one for the launch of Merck's immunotherapy Keytruda, he noted, adding that the company does more PD-L1 testing than any competing laboratory, he said.

The Dako test was initially approved by the US Food and Drug Administration as a companion diagnostic for Keytruda for non-small cell lung cancer in late 2015. The FDA has since approved the test for use as a companion diagnostic for the drug for other cancers, most recently two weeks ago for cervical cancer

PPD has a dedicated biomarker operation that works with a range of clients across more than 20 therapeutic areas. More than one-third of trials currently supported at PPD have a precision medicine component, according to Fikry. PPD has long had experience in clinical trials and regulatory approvals, and has helped develop all of the top 20 cancer drugs, 19 of the top 20 biologics and 16 of the top 20 generics. Once a biomarker is identified, the will be well-positioned to work on assay development through commercialization in the lab space, he said.

The companies also noted that global capabilities are increasingly being required to compete for larger studies. The partnership will leverage PPD's global footprint, and NeoGenomics will open labs in Singapore and Shanghai, co-located with PPD labs in both locations, according to Cardoza and Fikry. The new NeoGenomics labs will offer oncology testing capabilities in flow cytometry, immunohistochemistry and FISH to start, they said.

The companies will leverage PPD's Preclarus data system for consolidating and standardizing data from multiple sources. IT teams from both companies have been working to bridge the two companies' systems so that Preclarus offers a seamless view of information from both companies to clients, Cardoza and Fikry said.

NeoGenomics and PPD began discussing the idea of forming an alliance late last year. Extensive discussions on how the companies could best work together occurred earlier this year, with the companies announcing the alliance on June 1.