The clinical sites that participated in the study collected and processed maternal plasma samples from 4,664 pregnant women at high risk for foetal aneuploidy.
A total of sixty-two trisomy 18 and twelve trisomy 13 pregnancies along with their matched controls (including the trisomy 21 cases and matched controls) were tested using the MaterniT21 LDT. When unblinded, the detection rate for trisomy 18 was 100% and for trisomy 13, was 91.7%, with false positive rates of 0.28% and 0.97%, respectively.
Fosun Pharma agrees XH-S004 overseas licensing deal
Itepekimab meets primary endpoint in one of two Phase 3 COPD trials
Inogen secures FDA clearance for SIMEOX 200 Airway Clearance Device
Infex Therapeutics begins Phase IIa trial for RESP-X in NCFB patients
Destiny Pharma launches research on XF-73 for cystic fibrosis MRSA infections
Polarean Imaging enters into trade-in agreement with University of Kansas Medical Center
Sionna Therapeutics doses first healthy subject in SION-109 phase one clinical trial
Arcturus Therapeutics granted FDA Orphan Drug Designation for ARCT-032 to treat cystic fibrosis
SpliSense completes SPL84 first-in-human, Phase one clinical trial for cystic fibrosis treatment
Positive Phase 2, Proof-of-Concept Results for VX-548 Published in New England Journal of Medicine
Inogen acquires Physio-Assist, expanding respiratory product portfolio and global presence