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Philips Introduces OncoSignal Service for Cancer Pathway Signal Analysis

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NEW YORK (GenomeWeb) – Philips recently introduced an assay service called OncoSignal that the firm claims can determine pathway activity in various cancers, providing information that can be used to guide therapy selection.

The Dutch multinational is now on track to introduce a kitted version of the assay, which can be run on standard quantitative PCR equipment, by the end of the year, according to Jos Rijntjes, head of commercial operations at Philips Molecular Pathway Diagnostics.

"We are in the early stages of bringing this to market," said Rijntjes, noting that the assay is run out of Philips' laboratory in Eindhoven, the Netherlands. "At this moment, this is for research use only, but of course it is our ambition to go into clinical validation as quickly as possible and validate it more as time goes by."

Philips established its Molecular Pathway Diagnostics business last year to commercialize technology developed within Philips Central Research Facilities. According to Rijntjes, Philips Molecular Pathway Dx is one of the company's various venture businesses, which are "nurtured until they reach a certain maturity" before being adopted by one of the firm's existing units.

"This is our way of bringing new products to market," he said.

OncoSignal is the business's sole offering. A qPCR panel that tests for mRNA sequences associated with signal activity in diverse cancer-associated pathways, OncoSignal can currently be used to detect activity in the estrogen receptor, androgen receptor, FOXO/phosphoinositide 3-kinase, Hedgehog, Wnt, TGF-ß, and Notch pathways.

Additionally, Philips intends to add the AP1, PR, JAK/STAT, and NF-κB pathways to the kit "as soon as possible" said Rijntjes. The firm claims a turnaround time of one day, and the results are analyzed either using a web-based analysis tool or as a module within Philips IntelliSpace Genomics, a multi-omics molecular data-analysis tool marketed to pathologists and radiologists.

Philips believes that this approach of measuring mRNA expression distinguishes OncoSignal from other assays on the market that focus on the presence or absence of genetic mutations or aberrations. Rijntjes said that sometimes the presence of such variants does not indicate pathway activity, meaning that treatments are being selected for patients based on erroneous information.

He gave as an example breast cancer patients who are treated with tamoxifen based on the presence of estrogen receptors in tumor cells. "A certain percentage reacts well, but there's also a portion of patients that do not react well, because even though the estrogen receptor is there, that doesn't mean that it's active," said Rijntjes.

Scientists from Philips in a 2014 Cancer Research paper showed that OncoSignal could be used to determine which estrogen-receptor-positive breast cancer patients would react to treatment, based on its assessment of activity in that pathway. "In hindsight, we could tell which patients would react," said Rijntjes. "Just looking at the receptor tells you something, but not the entire story.

"It's important to look at the real activity of the pathway," Rijntjes added. "We do that by looking at the downstream RNA expression of genes regulated by the pathway transcription factor, and a Bayesian model is used to translate the gene expression into pathway activity" he said. "The advantage of that is that if you really look at the very end of the cascade, if you have that part analyzed, and you see there is a difference in expression of mRNA, then that's a strong sign that the pathway is active."

The OncoSignal service is currently being offered for research use only, and the kits that Philips intends to launch at the end of the year will similarly be marketed for research. However, Rijntjes noted, customers, such as laboratories that serve hospitals, could use OncoSignal as a component of their laboratory-developed tests. Gaining regulatory clearance to sell OncoSignal for clinical use remains a more distant goal for Philips.

"Of course at the end of the day, we want to have everything CE-IVD and US Food and Drug Administration approved," said Rijntjes. Should Philips eventually opt to take OncoSignal through the FDA, it would have to narrow in on specific applications for the test.

Rijntjes said that other papers demonstrating the use of OncoSignal have either been accepted for publication or are being prepared, but have not yet appeared.

OncoSignal relies on RNA extracted from formalin-fixed, paraffin-embedded tissue or fresh frozen tissue as an input. It makes use of standard approaches and equipment for carrying out RNA extraction and running qPCR on 96-well plates. "We designed the assay in such a way that it can be performed on standard equipment," said Rijntjes.

He noted that Philips has worked to reduce the complexity of the assay, selecting around a dozen sequences that both enable users to determine whether or not a pathway is active, as well as to discriminate one pathway from the other.

Potential users of OncoSignal include cancer researchers, as well as pharmaceutical partners. Rijntjes said that the assay could be applied "in the preclinical world, such as in cell models or in pharmacogenomic models." Pharma customers meantime might find OncoSignal useful for stratifying patients or for use in clinical trials.

Rijntjes noted that the genes interrogated by OncoSignal "have similar expression across the entire cancer field," meaning that regardless of the cancer being tested, as long as a certain pathway is being expressed, therapies targeting those pathways can be prescribed by clinicians.

"Whether it's prostate cancer, breast cancer, or ovarian cancer, that comes second," said Rijntjes. He noted that Philips aims to add new pathways to OncoSignal, but will continue to offer it as a single assay or service.