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GE's Clarient to be Key Beneficiary of $1B Bid to Bolster Molecular Dx Presence in Oncology


Originally published Sept. 19.

By Turna Ray

GE Healthcare's cancer diagnostics subsidiary Clarient will likely receive a hefty portion of $1 billion in R&D funds that the technology giant recently set aside for developing new tests, technologies, and treatments for cancer.

GE purchased Clarient last year to gain access to an array of molecular oncology tests. The acquisition represents GE's latest push into the personalized medicine space, after investing in genomic diagnostics firm CardioDx in 2010 (PGx Reporter 10/27/2010, 5/19/2010).

GE last week cited Clarient's biomarker research as one of several initiatives that will benefit from $1 billion in dedicated R&D funds over the next five years. The company also announced a $100 million innovation challenge to spur the development of tools that will help personalize breast cancer treatments.

GE is already a leader in cancer imaging technologies. With this added R&D funding and the innovation challenge, the company aims to spur the development of diagnostics that can help physicians treat patients with drugs that target the specific molecular features of their disease.

According to a GE Healthcare spokesperson, Clarient represents the best example of GE Healthcare's growing presence in the personalized healthcare space. The company markets a range of products on its Insight Dx platform, including the prognostic test Mammostrat, which assesses whether a breast cancer patient is at low, moderate, or high risk of disease recurrence. Using the "risk index" provided by the test, in addition to other molecular measures of disease such as ER, PR, HER2, and Ki-67 testing, a doctor can determine whether a breast cancer patient has a high risk of disease recurrence and should therefore be treated with chemotherapy.

Another test that Clarient runs as a laboratory-developed test on its Insight Dx platform is Pulmotype, a five-antibody immunohistochemistry test that can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in non-small cell lung cancer tumor specimens. According to the company, the test can help pathologists determine whether NSCLC patients will benefit from a range of treatment options.

Clarient is also in the process of developing a new pharmacogenetic test that gauges the TLE3 gene, associated with response to taxane-based chemotherapies. With this test, Clarient hopes to provide doctors with a tool to determine which breast, lung, and ovarian cancer patients can forego taxane-based treatments because they won't respond to this kind of therapy.

A GE spokesperson told PGx Reporter that Clarient has already published three papers on TLE3 and is currently preparing two more publications. GE and Clarient have an internal goal to validate the test on 1,000 patients.

"Since this will be a lab-developed test in the US, we are covered under CLIA and so the [TLE3] test is not governed by the [Food and Drug Administration]," the spokesperson added. "The test is already validated in our lab, so once we get this next round of papers published and reimbursement from some major payers and Medicare, we will launch [the test] most likely in 2013."

With the aid of the additional R&D investment, Clarient and GE will also advance a multiplex immunohistochemistry test that oncologists can use to identify the pathways driving a particular patient's cancer.

"Clarient pathologists recently identified a unique cancer diagnostic technology at GE Global Research that may give a clearer picture of the pathways driving specific tumors, and in turn may lead to more effective, personalized treatment recommendations," the spokesperson said. "It is Clarient’s goal that by developing this sophisticated multiplexing technology, pathologists will be able to conduct more than 50 different stains on a single tissue section."

Eli Lilly has been collaborating with GE and has used the multiplex test to study drug signaling pathways. "Now the multiplexing technology is being transitioned to Clarient pathologists, where they will take it to the next level and translate it to cancer diagnostics," the GE spokesperson said.

The spokesperson couldn't provide a specific data for the launch of this test, but said that it would be commercialized in the "very near future."

To spur innovation in the breast cancer personalized medicine field through its Healthymagination Challenge, GE has also launched a competition in which research teams with technologies enabling early cancer detection and treatment individualization can receive up to $100 million in development funding.

Through the competition, GE aims to specifically promote the development of diagnostic tools that will increase healthcare professionals' understanding of the molecular features of triple-negative breast cancer tumors and elucidate the similarities between breast cancer tumors and other solid tumors, so the disease can be caught early and treatment can be personalized.

The funds for this challenge were pledged by a number of venture capital firms: Kleiner Perkins Caufield and Byers, Venrock, Mohr Davidow Ventures, and MPM Capital. The winning entrants could be offered a potential commercial partnership with GE Healthcare, as well as receive $100,000 in funding.

This article has been corrected to note that GE did not purchase CardioDx but invested in the firm.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

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