The Berlin-based company is planning to market the test in Germany, Switzerland, and Austria. Epigenomics will partner with distributors Abbott Molecular and Quest Diagnostics to launch the test in other European countries, as well as the US.
OSU Medical Center will enroll patients who agree to join Coriell's personalized medicine project under the guidance of their primary care physician. The partners will study the impact of using genomic information in treating chronic conditions.
Qiagen said that the acquisition, along with the fact that it has more than 15 companion diagnostic collaborations with pharma companies, provides it with a leading position in the personalized healthcare market.
In an interview with Pharmacogenomics Reporter this week, Hakan Sakul provided a snapshot of Pfizer's efforts in personalized medicine, the company's stance on regulatory issues, and its overall focus on "omics"-guided medicine.
The results from the Australian study may have implications for US consumers, since similar to Australia, US law bars health insurers from discriminating based on genetic information, but not companies providing life and disability insurance.
"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.
A Phase III prospective study shows Vectibix combined with an irinotecan-based chemotherapy regimen improves progression-free survival in patients with wild-type KRAS tumors compared to chemotherapy alone. The study did not reach statistical significance for showing improvement in overall survival, however.