GynEC®-DX is an early diagnosis test exclusively aimed at health professionals, gynecologists or pathologists, who want to rule out cancer in patients at risk.
The reliability or accuracy of a diagnostic test is the probability that a correct result is obtained. It is calculated by dividing the sum of true positives and true negatives by the total of samples. The clinical study demonstrated that GynEC®-DX has a reliability of 96.5%.
The specificity of a test is the probability that a healthy subject will have a negative test result. The clinical study showed that GynEC®-DX has a specificity of 97%.
The sensitivity is the probability of correctly classifying a sick individual, ie the probability that a positive result will be obtained for a sick person. The clinical study showed that GynEC®-DX has a sensitivity of 91%.
It is the probability of not having the disease if the result of the diagnostic test is negative. The clinical study showed that GynEC®-DX has a NPV of 99%.
It is the probability of having the disease if the result of the diagnostic test is positive. The clinical study showed that GynEC®-DX has a PPV of 79%.
In the development phase, 20 genes biomarkers of early stages of endometrial cancer were identified (Int. J. Cancer 2011, 129: 2435–44): ACAA1, AP1M2, CGN, DDR1, EPS8L2, FASTKD1, GMIP, IKBKE, P2RX4, P4HB, PHKG2, PPFIBP2, PPP1R16A, RASSF7, RNF183, SIRT6, TJP3, EFEMP2, SOCS2 y DCN
The mean duration of endometrial cancer development is unknown, furthermore this time depends on factors such as age, obesity, previous treatment with hormones, family history, etc. It is the physician who, depending on the patient’s clinical history and symptoms, adjusts the follow-up.