Patent ID: 8119341

Claim:
An in vitro method for diagnosing or detecting a predisposition for a tendency to pregnancy loss (waste) and/or a higher risk to develop anti-phospholipid antibodies in a human, said method comprising steps of (a) obtaining a biological sample, wherein the biological sample is from a human individual, and the biological sample comprises nucleic acid; (b) detecting point mutations (substitutions) (i)-(iv) in the individual's ANXA5 gene regulation element as follows: (i) a G to A substitution at a position which corresponds to position 186 of SEQ ID NO: 2, (ii) an A to C substitution at a position which corresponds to position 203 of SEQ ID NO: 2, (iii) a T to C substitution at a position which corresponds to position 229 of SEQ ID NO: 2, and (iv) a G to A substitution at a position which corresponds to position 276 of SEQ ID NO: 2; and (c) diagnosing the individual with, or detecting in the individual, a predisposition for a tendency to pregnancy loss (waste) and/or a higher risk to develop anti-phospholipid antibodies.