V1 - sensitivity (80%) specificity (86%) overall a
Post# of 30028
V2 - sensitivity (90%) specificity (71%) overall acc (83%) (p=0.0059)
IMHO, these are excellent results:
1. Using the same CD69 expression, based on statistics theory, there will be a trade-off between sensitivity and specificity, i.e. sensitivity cannot be increased without expense of specificity
2. V2 has very high sensitivity at 90% which is particularly useful for RUO market to get the true positive patients (least false negative). It is understood that large failure of AD trials till date is due to too many false negative patients recruited for trials.
3. Both V1 and V2 are statistically significant, validating the science
4. Lympro (on univariate CD69 alone) is measuring stage-independent biology in AD patients.
There are a few other points:
1. If there is a need for a AD trial to also minimise risk in not getting truly healthy patients, the V1 Lympro (CD69) can be used given its high specificity (86%) as an additional diagnostics filter. This would also mean more business for Lympro products.
2. V1 and V2 can be subsequently used for the target markets:
a) Medical insurers - V2 to determine if the applicant is truly positive for AD (high sensitivity of 90%)
b) Doctors - V1 to make sure that the patient really has no AD so that a true AD patient will not be left undetected for treatment (high specificity of 86%)
And we are talking only about univariate Lympro.
Imagine if multivariate Lympro is available too.