US company Vermillion recieved FDA approval for 5 biomarkers which included the current diagnostic marker CA-125 . They wouldnt of recieved FDA approval if it wasnt a better test than the current marker CA-125. HTX currently uses 5 biomarkers including CA-125 and is moving towards 7 biomarkers which is an even more accurate test than CA-125.
background on CA-125 discovered in 1981 tells how its not a very effective marker thats why HTX has come up with a more superior product.
http://en.wikipedia.org/wiki/CA-125
CA-125 is not perfectly specific for cancer nor is it perfectly sensitive since not every patient with cancer will have elevated levels of CA-125 in the blood. For example, 79% of all ovarian cancers are positive for CA-125, whereas the remainder do not express this antigen at all.
Ranges in ovarian cancer
While this test is not generally regarded as useful for large scale screening by the medical community, a high value may be an indication that the woman should receive further diagnostic screening or treatment. Normal values range from 0 to 35 (g/mL). Elevated levels in post-menopausal women are usually an indication that further screening is necessary. In pre-menopausal women, the test is less reliable as values are often elevated due to a number of non-cancerous causes, and a value above 35 is not necessarily a cause for concern.
HTX Price at posting:
9.8¢ Sentiment: None Disclosure: Held
