Genomic Health Test to Guide Chemo Per New Breast Cancer Rule

Genomic Health, Inc. GHDX recently announced that, based on favorable outcomes from the prospective TAILORx and PlanB studies, the Oncotype DX Breast Recurrence Score test has been recommended to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative early-stage breast cancer with or without lymph node involvement (up to three positive nodes). This recommendation was given by the 16^th St. Gallen International Breast Cancer Conference Expert panel.

This is a major development in the company’s endeavor to strengthen its breast cancer treatment portfolio.

More About the Guidelines

The panelists examined the results of the milestone TAILORx study and cited that women with node-negative cancer and Recurrence Score less than or equal to 25 do not require chemotherapy treatment. This group represents up to 80% of patients who may be spared chemotherapy entirely. The Breast Recurrence Score test also detects those patients (with score test results of 26 to 100) who may receive a life-saving benefit from chemotherapy.

In the new guidelines, genomic testing with robust validation through prospective, randomized clinical trials is given preference over clinical-pathological features "for basing the critical yes/no chemotherapy decision."

The Oncotype DX Breast Recurrence Score test has been used in all major international guidelines.

Market Prospects

According to a new report by Grand View Research, the global breast cancer drug market size is estimated to reach a worth of $38.4 billion by 2025, at a CAGR of 10.7%. Hence, the guidelines come at an ideal time.

Recent Developments

Lately, results of the TAILORx study have paved the way for a few positive treatment guideline updates distinguishing the Oncotype DX Breast Recurrence Score test from prognostic-only tests based on clinical evidence and the significance of predicting chemotherapy benefit. This includes the recent update to ASCO guidelines, which identified an increased proportion of women who can be effectively spared of chemotherapy treatment based on their Recurrence Score results. This yet again underscores the importance of Breast Recurrence Score test for all medically eligible early-stage breast cancer patients.

Similar to the St. Gallen guidelines, the recently-updated ESMO guidelines refer to TAILORx and PlanB study results, which identify groups of patients — both in the node-negative and node-positive setting — who do not require chemotherapy. This also highlights the clinical utility of the Breast Recurrence Score test in guiding chemotherapy treatment decision.

Price Performance

In the past year, the stock has rallied 27.2% compared with the industry’s decline of 23.2%.

Zacks Rank and Other Key Picks

Genomic Health carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical space are Medtronic MDT, Baxter BAX and NuVasive NUVA, each carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Medtronic’s long-term earnings growth rate is expected at 7.13%.

Baxter’s long-term earnings growth rate is projected at 12.8%.

NuVasive’s long-term earnings growth rate is expected to be 12.75%.

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