Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.
Qiagen's "Day-One" lab readiness program is designed to expedite patient access to its CDx tests following regulatory approval of the tests and associated drugs.
The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.
Qiagen's Q4 revenues of $403.2 million fell short of the consensus analyst estimate though its adjusted EPS of $.40 was in line with Wall Street expectations.
The researchers also determined that the two most widely used IGRAs used for diagnosing the disease in developed countries are not accurate for active TB.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
At JP Morgan, Qiagen CEO Peer Schatz discussed a new digital PCR system and handheld reader for TB testing; Qiagen's acquisition of N-of-One; and its new sample prep system.
