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Genomic Health Awarded New Patents Covering Oncotype DX Technology; Reports Revenue Growth in Q2

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By Turna Ray

Genomic Health has been granted two new US patents for its Oncotype DX breast cancer test, the company announced this week during its second quarter earnings call with investors.

According to the company, the patents cover "methods for the algorithms used and methods utilizing genes beyond the current 21 gene set."

Genomic Health has previously said it intends to expand the gene set interrogated by Oncotype DX as new research becomes available.

The US Patent & Trademark Office on April 28 issued US Patent No. 7,526,387, "Expression profile algorithm and test for cancer prognosis," which covers the algorithm used to analyze gene expression levels and yield the Oncotype DX recurrence score.

Another patent granted by USPTO on Aug. 4, No. 7,569,345, "Gene expression markers for breast cancer prognosis," covers methods for assaying the expression level of an RNA transcript, called MYBL2, or its expression product, in a tissue sample from a breast cancer patient.

The new patents join two patents that the USPTO awarded the firm in 2006: No. 7,081,340, "Gene expression profiling in biopsied tumor tissues," and No. 7,056,674, "Prediction of likelihood of cancer recurrence."

The company said in a statement this week that it was also granted a patent by the European Patent Office during the first quarter that gives it the "rights to monitor gene expression using intronic regions of genes."

During the earning call, Genomic Health CEO Kim Popovits said the company is considering whether to begin offering testing for additional cancer markers, such as KRAS, that are beginning to be accepted within the healthcare community.

Recently, the US Food and Drug Administration updated the labeling for two colorectal cancer drugs, Amgen's Vectibix and BMS/ImClone's Erbitux, to indicate that patients with certain mutations in their KRAS gene will not benefit from such drugs [see PGx Reporter 07-22-2009].

“We are right now evaluating what role we should be playing and being able to provide some of these additional markers,” Popovits said. “As you know we have done it with Oncotype DX breast cancer by providing ER, PR, and HER,2 and as we look towards launching the colon cancer test we are certainly aware that there is some additional markers there that maybe useful for patients that we may want to provide along with the test. So, that is being evaluated right now and we will announce that as we move closer to launching the colon cancer test.”

Genomic Health is planning to launch a colorectal cancer test based on Oncotype DX’s platform in early 2010.

Additionally, Genomic Health also said it has completed processing samples for it renal cancer gene identification study with the Cleveland Clinic and Pfizer. Last year, Genomic Health said it was developing a genomic test for Pfizer, based on the diagnostic company’s Oncotype DX technology to gauge the risk of post-operative kidney cancer recurrence [see PGx Reporter 01-09-2008].

Financial Results

For the three months ended June 30, Genomic Health's total revenue increased to $36.6 million from $27.8 million from the same period a year ago. Product revenue from the Oncotype DX breast cancer test was $35.2 million in the second quarter, representing a 34 percent increase from the year-ago period.

The company also narrowed its net loss during the quarter, to $3.9 million from $4.1 million in the second quarter of 2008.

Genomic Health completed the quarter with $55.7 million in cash, cash equivalents, and short-term investments, of which $11.4 million is in cash and equivalents.

During the call, Genomic Health officials denied that that the firm is facing any competition from Agendia. The Netherlands-based Agendia recently announced it would increased its sales force in the US to drive adoption of its breast cancer recurrence test MammaPrint on the strength of clinical trial data validating the assay's predictive and prognostic capabilities [see PGx Reporter 06-03-2009].

"The clinical evidence driving acceptance here … we have not seen any change as a result of Agendia," Popovits said during the call.