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GE's Clarient Gains IP Rights from Insight Genetics to Develop PCR-based ALK Test

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Originally published June 1.

With the aim of inking companion diagnostic partnerships with pharma companies investigating drugs inhibiting the anaplastic lymphoma kinase, GE Healthcare announced plans this week to develop a PCR-based ALK-mutation test.

Clarient Diagnostic Services, a GE subsidiary, has garnered a worldwide, non-exclusive license from Insight Genetics enabling it to develop a genetic test that gauges ALK expression.

Currently, Pfizer's non-small cell lung cancer drug Xalkori is the only ALK inhibitor approved by the US Food and Drug Administration. Abbott's Vysis ALK Break Apart FISH Probe test is the FDA-approved companion diagnostic for the drug.

Clarient offers the Abbott test through its diagnostics services lab, but now plans to evaluate the performance of a quantitative PCR-based test to analyze increased transcription of the ALK gene. "PCR addresses some of the inherent limitations of fluorescence in situ hybridization and immunohistochemistry approaches," a GE spokesperson told PGx Reporter, but did not elaborate.

In 2010, Yung-Jue Bang, a professor at the Seoul National University College of Medicine and a collaborator on Pfizer's Xalkori development program, said that the Abbott FISH test had nearly 100 percent concordance with IHC tests conducted in his laboratory (PGx Reporter 6/9/2010). Pfizer has said it is also exploring RT-PCR platforms for ALK testing.

ALK can spur cancer by fusing with other genes or through mutations in the gene itself. FISH tests can detect rearrangements in the ALK gene, IHC tests gauge the expression of the ALK protein, and PCR-based tests can hone in the specific ALK fusion transcripts. EML4-ALK fusion genes are responsible for between 3 percent and 5 percent of NSCLC, fusions between ALK and the nucleophosmin genes are associated with 60 percent of anaplastic large cell lymphomas; and ALK mutations have been linked to between 10 percent and 15 percent of childhood neuroblastoma.

GE said in a statement that more than 250,000 newly diagnosed cancers in the US may be attributed to ALK mutations and fusions, including colorectal and breast cancers.

Noting that a number of investigational ALK inhibitors are currently undergoing clinical trials, GE said it intends to first develop a lab-developed ALK mutation test and partner with drug companies that want to hone in on best responders for their drugs.

"Clarient will develop this test as an LDT to be made available to pharma companies with ALK inhibitors under development," the GE spokesperson said. "If the compound were to show promise, we would then seek to enter into a development agreement to bring the test to the US Food and Drug Administration, either as a cleared LDT or in partnership with an in vitro diagnostics company."

Clarient expects to complete the necessary clinical validation studies for the LDT in the next six months.

"The validation studies that will be performed include very standard assessments of sensitivity, specificity, repeatability, and reproducibility," the spokesperson said. "However, in the near term, we plan to focus on working with pharmaceutical companies to deeply analyze ALK positive samples, from PCR and sequencing standpoints."

Separately this week, Insight inked a deal with Kindstar Globalgene Technology in Beijing to market cancer diagnostics in China. Under the terms of the agreement, the first test that Insight will add to Kindstar's menu of diagnostics is its ALK Screen lung cancer test. Kindstar will offer the test from its labs located in Wuhan, Beijing and Shanghai.

Similar to the deal with GE, Insight's ALK test for the Chinese market is also based on a PCR platform. Insight said in a statement that the test gauges "cancer-causing fusions and mutations of ALK."

Furthermore, the company highlighted that the PCR-based test offers certain advantages over ALK tests based on other technologies.

"Comparison testing has shown that Insight ALK Screen has many benefits over other ALK testing methods, including FISH and IHC," the company said in a statement. "The assay offers the accuracy and reliability advantages of a qPCR platform without the need for validated primer pair for each fusion."

Additionally, according to Insight, "unlike a variant-specific multiplex strategy, Insight ALK Screen can detect the presence of any fusion within the ALK gene. It also can identify ALK up-regulation without using a secondary platform."

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