According to Kalorama, histopathology IVD companies Dako, Ventana Medical, Roche Diagnostics and Third Wave Technologies lead the market with FDA-cleared tests.Oncotype DX was launched in the United States in 2004, where it has since been adopted as the standard of care for treating early-stage breast cancer.Oncotype DX is recommended in the guidelines of the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN), and is extensively reimbursed in the United States.

 

Physicians use Oncotype DX to predict the likelihood of chemotherapy benefit, as well as the likelihood of recurrence, for patients with early-stage breast cancer, in order to make individualized treatment decisions about the addition of chemotherapy to hormonal therapy.

 

By 2025, one in five new drugs could be labeled with a companion test, many of which will be cancer drugs, according to Kalorama. Many of the new companion tests are being developed as diagnostic/prescription partnerships.

 

There are scores of these cancer co-development projects underway. Companies such as Qiagen/DxS, MolecularMD and Roche/454 Life Sciences launched CE Marked test kits in 2008 and 2009. These tests are performed using blood instead of biopsied tissue.

 

Kalorama believes better-than-average growth levels will drive more companies to this area.

 

"This trend to personalized medicine is expected to create a huge market for cancer diagnostics in combination with the commercialization of the therapy," Rosen says. "We expect pharmacogenomics, predisposition diagnostics and molecular diagnostics to show 25 to 30 percent annual growth over the next five to 10 years."