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Thermo Fisher, Pfizer, Novartis Ready CDx Assay for FDA Submission

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NEW YORK (GenomeWeb) – Thermo Fisher Scientific has completed the analytical validation of its universal companion diagnostic test that it is developing with Pfizer and Novartis, the company said this week.

At Arrowhead's Personalized and Precision Medicine conference in San Francisco this week, Mark Stevenson, executive vice president and president of life science solutions at Thermo Fisher, told GenomeWeb that with the analytical validation complete, the companies will now conduct the necessary clinical trials in order to submit the assay, which will run on Thermo Fisher's Ion Torrent PGM Dx platform, to the US Food and Drug Administration together with Pfizer's and Novartis' drugs.

Stevenson did not provide a timeline for when the first submission would occur, but said it would be "fairly soon."

The assay will analyze both DNA alterations and RNA gene fusions from around 50 genes using the AmpliSeq technology, Stevenson said.

The three companies collaborated on the design and analytical validation of the assay, Stevenson said, which was viewed as a pre-competitive space by the pharma companies. Pfizer and Novartis both plan to submit the assay to the FDA in conjunction with a lung cancer drug, but the companies each have their own target and will do their own submissions. Even though the test will analyze multiple markers, the FDA submissions will still be for one marker associated with one drug.

Once it is cleared, the test will be marketed as a kit to hospital laboratories, oncology centers, and other molecular diagnostic labs, Stevenson said.

The traditional paradigm for companion diagnostics has been one test for one drug. But, in recent years, test developers and pharmaceutical companies alike have been searching for a better model.

During a panel discussion at the conference this week, representatives from Pfizer and Novartis discussed their reasoning for collaborating on a multi-marker companion diagnostic.

Anne-Marie Martin, senior vice president and global head of oncology precision medicine at Novartis, said that the project essentially began out of frustration. The pharmaceutical companies wanted a "simpler way to evaluate patient samples and maximize the information," she said. "When you look at the deluge of tests on the market, it's very complex."

Hakan Sakul, vice president and head of diagnostics at Pfizer, agreed. "Testing with panels takes away the need to go one test after another," he said, which has "a whole list of problems" including the possibility of running out of limited patient tissue and potentially delaying treatment if multiple tests have to be run before a match is found. 

The goal of the collaboration was to "get as much information as possible and minimize the number of tests" that had to be run, Martin said.

And, although pharmaceutical companies are not known for their openness and co-collaboration, Martin said the project was a no-brainer. The companies could share in the cost of assay development and analytical validation in a pre-competitive space, while still maintaining the intellectual property surrounding their drugs. Martin added that even though the companies knew they would "enable something that others would benefit from, we were ok with that because ultimately it's about identifying the right patient for the right therapy, and we're developing the therapy," she said.

The companies are also working together to determine how they will market and commercialize the test. "Medical adoption is a very important piece," Sakul said. "The three companies are working together to develop educational material," he said. Stevenson added that while Thermo has significant sales experience, it does not sell its products directly to oncologists, so "we're trying to figure out how best to commercialize and partner together to have a successful model," he said.

The firms are also discussing other aspects of commercialization, such as payor adoption, he said.

The current collaboration is between Pfizer, Novartis, and Thermo Fisher, but the companies said that the way the assay is being developed, other pharmaceutical companies could also join in. The company would be responsible for its own clinical trial and submission to the FDA, but could take advantage of the fact that the assay is already analytically validated.

Thermo's PGM Dx is already listed with the FDA as a Class II medical device, however, the listing does not include analyzing somatic mutations from oncology samples. One part of the current collaboration is demonstrating to the FDA that the PGM can analyze somatic mutations from as little as 10 nanograms of formalin-fixed paraffin-embedded tissue, Stevenson said.

Obtaining clearance to analyze somatic mutations would pave the way to bring additional oncology tests through the FDA, he added.

Looking several years down the road, Sakul said that there would be opportunities to develop additional panels, including panels with different targets or panels that analyze different sample types, like from blood, for instance. The current panel is predominantly focused on mutations that are relevant for lung cancer, and in particular, non-small cell lung cancer.

Others are also looking to develop universal companion diagnostic tests based on NGS technology. Illumina is collaborating with AstraZeneca, Janssen Biotech, and Sanofi to develop an NGS-based universial CDx. The companies have not provided details about the test including how many genes it will analyze and for what indications it will apply. Illumina is also developing a CDx with Amgen for its colorectal cancer drug Vectibix, which it has said would be its first pre-market approval application in oncology.