Methods and compositions for diangosis of ectopic pregnancy
AssigneesThe Wistar Institute of Anatomy and Biology, The Trustees of the University of Pennsylvania
InventorsDavid W. Speicher, Kurt T. Barnhart, Aaron R. Goldman
Life of this patent
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Abstract
Methods and compositions are provided for diagnosing ectopic pregnancy or nonviable pregnancy in a mammalian subject by detecting changes in expression of the expression levels of one or more of proteins or peptide fragments.
Claims16
A diagnostic reagent or kit for use in diagnosing an ectopic pregnancy in a mammalian subject comprising:
- (a) a ligand that that binds to a peptide or protein selected from the group consisting of:
- i. disintegrin and metalloproteinase domain-containing protein 12 (ADAM12),
- ii. Glycoprotein hormones alpha chain (CGA),
- iii. Choriogonadotropin subunit beta (CGB),
- iv. Isthmin-2 (ISM2),
- v. protein notum homolog (NOTUM),
- vi. Glycodelin (PAEP),
- vii Pappalysin-1 (PAPPA0,
- viii. pregnancy specific beta-1 glycoprotein, isoform 1 (PSG1),
- ix. pregnancy specific beta-1 glycoprotein, isoform 2 (PSG2),
- x. pregnancy specific beta-1 glycoprotein, isoform 3 (PSG3),
- xi. pregnancy specific beta-1 glycoprotein, isoform 9 (PSG9),
- xii. pregnancy specific beta-1 glycoprotein, isoform 11 (PSG11),
- xiii. pregnancy specific beta-1 glycoprotein, isoforms 6 and 9 (PSG6/9), and
- xiv. pregnancy specific beta-1 glycoprotein, isoforms 8 and 1 (PSG8/1), or
- (b) a combination of ligand (a), wherein each ligand binds to a different peptide or protein (i) through (xiv);
- wherein at least one of the ligands is associated with a detectable label or with a substrate.
The reagent or kit according to claim 8, wherein said ligand is an antibody or fragment thereof.
A method for diagnosing an ectopic pregnancy in a female mammalian subject comprising:
- (a) measuring in a biological fluid sample of the subject the expression level of a protein or peptide fragment thereof selected from the group consisting of:
- i. disintegrin and metalloproteinase domain-containing protein 12 (ADAM12),
- ii. Glycoprotein hormones alpha chain (CGA),
- iii. Choriogonadotropin subunit beta (CGB),
- iv. Isthmin-2 (ISM2),
- v. protein notum homolog (NOTUM),
- vi. Glycodelin (PAEP),
- vii Pappalysin-1 (PAPPA0,
- viii. pregnancy specific beta-1 glycoprotein, isoform 1 (PSG1),
- ix. pregnancy specific beta-1 glycoprotein, isoform 2 (PSG2),
- x. pregnancy specific beta-1 glycoprotein, isoform 3 (PSG3),
- xi. pregnancy specific beta-1 glycoprotein, isoform 9 (PSG9),
- xii. pregnancy specific beta-1 glycoprotein, isoform 11 (PSG11),
- xiii. pregnancy specific beta-1 glycoprotein, isoforms 6 and 9 (PSG6/9), and
- xiv. pregnancy specific beta-1 glycoprotein, isoforms 8 and 1 (PSG8/1),
- xv. a combination of any of (i) through (xiv) and
- (b) comparing said subject's expression level of the selected protein or peptide fragment with the level of the same protein or peptide in the biological fluid of a reference or control female mammalian subject having a normal intrauterine pregnancy (IUP),
- wherein changes in expression of the subject's selected protein or peptide fragment from those of the reference or control correlates with a diagnosis of ectopic pregnancy.
Dependencies are inferred from the claim text.