Based on the above, multianalyte testing for evaluation of adnexal masses does not meet the TEC criteria.
2. The scientific evidence must permit conclusions concerning the effect of the technology
on health outcomes.
The evidence regarding the effect of OVA1 and ROMA and effects on health outcomes is indirect
and based on studies of diagnostic performance of the tests in patients undergoing surgery for
adnexal masses. Although the studies show improvements in sensitivity and worsening of specificity
with the use of the tests in conjunction with clinical assessment, there are problems in concluding
that this results in improved health outcomes. The clinical assessment performed in the
studies is not well characterized. Although OVA1 improves sensitivity, specificity declines so much
that most patients test positive. ROMA does not improve the sensitivity of testing to a great extent.
Underlying these issues is uncertainty regarding whether there would be actual health benefits
based on altering patient referral based on these tests.
3. The technology must improve the net health outcome; and
4. The technology must be as beneficial as any established alternatives.
Whether use of OVA1 or ROMA improves the net health outcome or is as beneficial as other
diagnostic strategies has not been demonstrated. Referring all patients to a physician with expertise
in staging and debulking ovarian cancer is a reasonable clinical alternative with no harm.
5. The improvement must be attainable outside the investigational setting.
Whether OVA1 or ROMA improves the net health outcome in the investigational setting has not
Interesting the stock is up 35% since this information was released on 4/8. On the surface is appears to be negative, but still a lot better then CA125. OVA1 could still become a replacement for CA125 which would make it a $100 Million+ business overnight. Something is us because volume and price movement is telling us there are some buyers at this point. We have had no real news except the Army study PR on 4/15 which was nothing substantial. ACOG conference and earnings call should make things interesting over the next two weeks.
Its been stated by many experts over and over that OVA1 is not to be used as a screening test, which is what CA125 is used for,a screening test. I do agree that OVA1 is much better then CA125. But I don't think OVA1 will ever be sanction as use for screening. I just hope that it will become part of the ACOG guidelines. But this negative Blue Cross statement doesn't help its cause.