Advanced Diagnostics: Innovation, Reimbursement, And Coverage Challenges

Advances in in vitro diagnostic testing have had a large and positive impact on the provision of health care over the past 15 years. This has been particularly apparent in oncology, starting in 1998 when Genentech Inc. launched its blockbuster treatment for HER2 positive breast cancer, Herceptin (trastuzumab). The development, approval, and launch of Herceptin occurred in conjunction with a companion test developed by Abbott Laboratories Inc.’s Abbott Diagnostics, and represented the first of a growing class of oncology drugs with companion diagnostics. Similarly, molecular prognostic tests such as Myriad Genetics Inc.’s BRACAnalysis test for BRCA1 and BRCA2 mutations can identify women at significantly elevated risk for developing breast or ovarian cancer, enabling at-risk women to consider medical management including more frequent monitoring procedures or risk-reducing surgery, when appropriate. Genomic Health Inc.’s Oncotype DX test helps guide treatment decisions by predicting the benefit of chemotherapy and the likelihood of recurrence.

Advances in diagnostics such as these are not limited exclusively to oncology. For example, noninvasive prenatal testing now allows at-risk...