Dive Brief:
- Qiagen said Wednesday it has expanded its collaboration with AstraZeneca to cover companion diagnostics for chronic diseases.
- The agreement, which moves the partnership beyond oncology, tasks Qiagen with developing and validating a genotyping assay for Qiastat-Dx. Qiagen currently uses the platform for infectious disease testing.
- Qiagen has identified companion diagnostics as a double-digit growth opportunity and said Qiastat-Dx sales rose 12% in the second quarter.
Dive Insight:
AstraZeneca began working with Qiagen on a cancer companion diagnostic 10 years ago. Oncology has remained the main use for companion diagnostics because many new cancer medicines are only effective in patients with certain biomarkers. The targeted therapies require tests that identify patients with those biomarkers, such as the diagnostic that Illumina won approval for this week.
Almost all the companion diagnostics authorized by the Food and Drug Administration support cancer drugs. There are exceptions though, with the list featuring hemophilia and obesity tests, and the use of companion diagnostics beyond cancer could increase if other treatments become more targeted.
AstraZeneca has partnered with Qiagen to develop a test for its genomically targeted medicines. Qiagen said the goal is to enable specialty care providers to perform genotyping while patients are undergoing routine clinical examination. The genotyping could show if a patient is suitable for treatment with one of AstraZeneca’s medicines.
The project involves Qiastat-Dx, a platform that uses real-time PCR to detect and differentiate between biomarkers in around one hour. Qiagen has developed cartridges for identifying the cause of respiratory, gastrointestinal and central nervous system infections. Neither AstraZeneca nor Qiagen has said what chronic disease the test will identify.
Qiagen landed the deal in the aftermath of a quarter in which Qiastat-Dx drove growth at the company. Sales of the platform grew 12% on a constant currency basis, CFO Roland Sackers said on an earnings call at the start of August. Sackers said the result reflected “significant gains in consumables and an ongoing good level of instrument placements.” Qiagen expects to report Qiastat-Dx sales of at least $100 million in 2024.
