Changed Risks for GENOMIC HEALTH INC (GHDX)

Here are risks that changed year over year. risks from the recent filings of GENOMIC HEALTH INC. Our algorithms work hard to highlight risks unique to this company.

Our dependence on distributors for sales of our Oncotype tests outside of the US could limit or prevent us from selling our test in foreign markets and impact our revenue

If our laboratory facilities become inoperable, we will be unable to perform our tests and our business will be harmed

We face risks associated with currency exchange rate fluctuations, which could adversely affect our operating results

New diagnostic product development involves a lengthy and complex process, and we may be unable to commercialize on a timely basis, or at all, any of the tests or products we develop individually or with our collaborators

We expect to rely on third parties in conducting any future studies of our diagnostic products that may be required by the FDA, the EU or other regulatory authorities, and to fulfill product registration requirements in foreign countries, and those third parties may not perform satisfactorily

If we are unable to obtain adequate regulatory clearances or approvals to market the in vitro diagnostic kits for our Oncotype DXi IVD Breast Recurrence Score tests in the countries in which we intend to commercialize this assay, or if regulatory limitations are placed on our diagnostic products, our business and growth will be harmed

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International expansion of our business exposes us to business, legal, regulatory, political, operational, financial, compliance and economic risks associated with doing business outside of the United States

Risks Relating to Product Development, Commercialization and Sales of our Products

Our strategy to seek to enter into strategic collaborations and licensing arrangements with third parties to develop diagnostic tests and other products may not be successful