Methods and compositions for diagnosis of ectopic pregnancy

摘要

Methods and compositions are provided for diagnosing ectopic pregnancy in a mammalian subject by detecting changes in expression of ISM2, ADAM12, PST1, PSG7, PST11, PSG9, PSG2 and other genes identified therein, including combinations thereof. A selected gene, gene transcript or protein/peptide expression product, or profiles or signatures formed by combinations of same, detected in a biological fluid of a subject, enables comparison of the corresponding genes, proteins or profiles from that of a reference or control having a normal intrauterine pregnancy. Detection of characteristic changes in the gene profile or protein expression signature of the subject is correlated with a diagnosis of ectopic pregnancy. Various compositions for use in such diagnosis include PCR primer-probe sets or ligands, labeled or immobilized, which are capable of detecting the changes in expression or translation of these targets.

主权项

1. A diagnostic reagent or kit for use in diagnosing an ectopic pregnancy in a mammalian subject consisting of:
i. a ligand that binds Isthmin2 (ISM2), ii. a ligand that binds the pro-domain or extracellular (EC) domain of ADAM12, iii. a ligand that binds pregnancy specific beta-1 glycoprotein isoform 7 (PSG7), iv. a ligand that binds pregnancy specific beta-1 glycoprotein isoform 11 (PSG11), v. a ligand that binds pregnancy specific beta-1 glycoprotein isoform 9 (PSG9), and vi. a ligand that binds pregnancy specific beta-1 glycoprotein isoform 2 (PSG2); wherein at least one of the ligands is covalently or non-covalently joined with a detectable label or immobilized upon a substrate.