Diagnostic kits and methods for early detection of ovarian cancer

A diagnostic composition comprising at least two detecting molecules or any combination or mixture of plurality of detecting molecules specific for determining the level of expression of at least two biomarker protein/s, wherein said at least two biomarker protein/s comprise at least one of:

• (i) at least one of C4b-binding protein beta chain (C4BPB) and Kinesin-like protein Family Member 20B (KIF20B);
• (ii) at least one of Vacuolar protein sorting-associated protein 11 homolog (VPS11), Cartilage acidic protein 1 (CRTAC1) and Meckelin (TMEM67);
• (iii) at least one of Gap junction alpha-1 protein (GJA1) and Plasma membrane calcium-transporting ATPase 4 (ATP2B4);
• and (iv) any combination of at least two biomarker proteins of any one of (i), (ii) and (iii) protein/s;
• and
• wherein each of said detecting molecules is specific for one of said biomarker protein/s.

A kit comprising:

• a. at least two detecting molecules specific for determining the level of expression of at least two biomarker protein/s in a biological sample, wherein said at least two biomarker protein/s comprise at least one of:
• (i) at least one of C4BPB and KIF20B;
• (ii) at least one of VPS11, CRTAC1 and TMEM67;
• (iii) at least one of GJA1 and ATP2B4;
• and (iv) any combination of at least two biomarker proteins of any one of (i), (ii) and (iii) protein/s or any combination thereof;
• wherein each of said detecting molecule/s is specific for one of said biomarker proteins;
• said kit optionally further comprises at least one of:
• b. pre-determined calibration curve/s or predetermined standard/s providing standard expression values of said at least two biomarker/s;
• and
• c. at least one control sample.

A method for treating and/or ameliorating ovarian cancer in a subject in need thereof, the method comprising:

• (a) detecting ovarian cancer in said subject by the steps of:
• (I) determining the expression level of at least two biomarker proteins in at least one biological sample of the diagnosed subject, to obtain an expression value for each of said at least two biomarker protein/s, wherein said at least two biomarker protein/s comprise at least one of:
• (i) at least one of C4b-binding protein beta chain (C4BPB) and Kinesin-like protein Family Member 20B (KIF20B);
• (ii) at least one of Vacuolar protein sorting-associated protein 11 homolog (VPS11), Cartilage acidic protein 1 (CRTAC1) and Meckelin (TMEM67);
• and (iii) at least one of Gap junction alpha-1 protein (GJA1) and Plasma membrane calcium-transporting ATPase 4 (ATP2B4);
• (iv) any combination of at least two biomarker proteins of any one of (i), (ii) and (iii);
• optionally, the subject is a subject determined as a carrier for at least one mutation in at least one gene associated with high risk for ovarian cancer;
• (II) determining if the expression value obtained in step (I) for each of the at least two biomarker protein/s is positive or negative with respect to a predetermined standard expression value or to an expression value of said biomarker protein/s in at least one control sample;
• wherein at least one of:
• a positive expression value of at least two biomarker proteins of at least one of said (i) C4BPB;
• (ii) at least one of VPS11, CRTAC1 and TMEM67;
• (iii) at least one of GJA1 and ATP2B4 and/or a negative expression value of KIF20B;
• and (iv) any combination of at least two biomarker proteins of any one of (i), (ii) and (iii), biomarker protein/s in said sample, indicates that said subject is suffering from ovarian cancer;
• and
• (b) administering to a subject detected as suffering from ovarian cancer according to step (a), an effective amount of at least one anti-cancer agent, or subjecting said subject to an anti cancer treatment regimen.