MMP-8 activation product, its determination and use

A method of treating a gynecological disease in a subject, wherein the gynecological disease consists of intra-amniotic inflammation, maternal inflammation, premature delivery, low birth weight, an amniotic pathology, or a combination thereof, the method comprising:

• (i) obtaining a non-oral sample from the subject;
• (ii) determining an early activation of matrix metalloproteinase-8 (MMP-8) in the non-oral sample by determining a level of a MMP-8 middle-part activation product from a middle region domain of the MMP-8 sequence, having a size between 10-35 kDa, and comprising SEQ ID NO:
• 1 and/or SEQ ID NO:
• 2, or a fragment of the MMP-8 middle-part activation product, in the non-oral sample, wherein the level of the MMP-8 middle-part activation product in the non-oral sample is an indicator of the level of active MMP-8 in the non-oral sample;
• (iii) comparing the level of the MMP-8 middle-part activation product, or fragment thereof, to the MMP-8 middle-part activation product, or fragment thereof, in a reference sample wherein:
• the reference sample is derived from a subject or a patient group that does not have the gynecological disease, wherein the subject has the gynecological disease if the level of the MMP-8 middle-part activation product, or fragment thereof, is greater than the level of the MMP-8 middle-part activation product, or fragment thereof, in the reference sample;
• or
• the reference sample is derived from a subject or a patient group that has the gynecological disease, wherein the subject has the gynecological disease if the level of the MMP-8 middle-part activation product, or fragment thereof, is about equal to or greater than the level of the MMP-8 middle-part activation product, or fragment thereof, detected in the reference sample;
• (iv) determining that the subject has the gynecological disease using the comparison from step (iii);
• and
• (v) treating the subject determined to have the disease for the gynecological disease.