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Genomic Health Plans Changes to Prostate Cancer Test Report

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NEW YORK (GenomeWeb) – Genomic Health officials said this week that changes are in the works for the report the company returns to physicians as part of its Oncotype DX prostate cancer risk test.

Supported by studies the company has published and shared at meetings over the last year, as well as another set of data slated for this week's annual meeting of the American Urological Association, Genomic Health plans to alter the report generated by the test to include an assessment of patients' 10-year risk for both metastasis and prostate cancer-specific death, Chief Medical Officer Phil Febbo said during a call discussing the company's Q1 earnings this week.

The company's current test report is limited to a genomic prediction of a patients' "current state of cancer … using genomics to predict the aggressiveness of that patient's tumor in the present moment," Febbo explained.

In other words, the report speaks to the test's ability to predict which clinically low- or intermediate-risk patients actually have a low-risk cancer — potentially helping to encourage them to avoid unnecessary surgery.

According to Genomic Health, expanding the analysis to include a more specific assessment of 10-year adverse outcomes could help the company better differentiate its test from competitors in the market, which include Myriad Genetics' Prolaris, and GenomeDx's Decipher biopsy test.

"We have found that some urologists base decisions on [current disease aggressiveness and some on 10-year risk], so we wanted to have both as part of the [test], and we are now validated to do that so we are immediately reflecting that in the report," he said.

"As we have been out working with clinicians and differentiating our test … in general I would say we are getting a great response to differentiation, to the data, and to our ability to put together a report that we believe will be one of a kind in terms of the questions it answers for clinicians and their patients," added Genomic Health President, CEO, and Chairman Kim Popovits.

Although Febbo claimed during the call that the changes make the firm's Oncotype DX genomic prostate score (GPS) the only test in the field that provides both prediction of the near-term state of patients' disease and their future long-term risk, Myriad Genetics notably also includes assessment of patients' 10-year disease specific mortality in its Prolaris test report, though not the risk of future metastasis.

Febbo said that company researchers will share data at the AUA meeting this week from a study performed using tissue samples from a Kaiser Permanente Northern California region database, which speak specifically to the ability of the Oncotype DX GPS to predict the risk that patients will die of their cancer within 10 years.

Earlier presentations have focused on the test's performance in predicting biochemical recurrence and metastasis. At the 2017 ASCO Genitourinary Cancers Symposium this February, for example, Genomic Health researchers highlighted data from the Kaiser Permanente cohort that demonstrated that the GPS was strongly associated with the rising PSA levels in patients following surgery that signal particularly aggressive disease, and predicted this biochemical recurrence independently of other clinical factors.

In March, at the European Association of Urology Congress in London, investigators reported that the GPS was strongly associated with metastases in a multivariable analysis.

"Importantly, in this study, no men with NCCN very low-, low-, and intermediate-risk prostate cancer who had a GPS less than 20 developed metastases," Febbo said.

"Given the strength of the Kaiser study results and the expected impact this will have on clinical practice we will be incorporating these new findings into a significant revision of our GPS patient report," Febbo said during Genomic Health's earnings call this week.

Though Genomic Health is working hard to use this data to differentiate its test, and to maintain what Popovits claimed is currently a leading position over competitors, it has fallen behind Myriad this year in pursuit of Medicare coverage for testing not just low-risk, but also intermediate-risk prostate cancer patients.

Medicare contractor Palmetto GBA issued a positive draft local coverage determination for Myriad's Prolaris test for intermediate-risk patients last December. The comment period for the draft ended in March, but the LCD has not yet been finalized.

Genomic Health initially expected to receive a positive draft LCD for its Oncotype DX GPS early this year, but Palmetto did not end up announcing the draft until last week.

"Now that we have a draft LCD for CMS intermediate coverage, we believe revenue [from intermediate-risk patient testing] will be a second-half event following the standard posting, comment, and finalization process," Genomic Health COO Brad Cole said during the firm's call this week.

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