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.
QuantiFeron-TB Gold Plus features antigens that measure the cell-mediated immune response to TB infection from both CD4 and CD8 T cells.
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.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
Qiagen will provide IUO tests for NeoGenomics to verify, set up, and run in clinical trials and in anticipation of regulatory approval.