Monogram Announces Commercial Availability of the HERmark(TM) Breast Ca...(monogrambio.com . Forward Looking Sta...),Health

Forward Looking Statements

Certain statements in this press release are forward-looking. These forward-looking statements include references to the ability of the HERmark assay to predict response to Herceptin or to significantly improve the information available to physicians, results of studies intended to demonstrate clinical utility of HERmark, and successful commercialization of the HERmark assay or other VeraTag assays. These forward-looking statements are subject to risks and uncertainties and other factors, which may cause actual results to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These risks and uncertainties include, but are not limited to: risks and uncertainties relating to the performance of our products, including HERmark; the risk that our VeraTag assays, including HERmark may not predict response to Herceptin or other therapeutic agents; the risk that we may not be able to obtain additional cohorts of patient samples for additional HERmark or VeraTag studies; our ability to successfully conduct clinical studies and the results obtained from those studies; whether larger confirmatory clinical studies will confirm the results of initial studies; our ability to establish reliable, high-volume operations at commercially reasonable costs; actual market acceptance of our products for patient use and adoption of our technological approach and products by pharmaceutical and biotechnology companies; our estimate of the size of our markets; our estimates of the levels of demand for our products; the impact of competition; whether payers will authorize reimbursement for our products and services and the amount of such reimbursement that may be allowed; whether the FDA or any other agency will decide to further regulate our products or services; whether the draft guidance on Multivariate Index Assays issued by FDA will be subsequently determined to apply
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