Randomly Fumbling Through the Day

Quite often in our business we move from one experiment to the next, never analyzing the previous set of data.  After a while people begin to believe that such a logical process is not possible in our special set of circumstances.  

Take for example the case of the gender assay from AcuGen Biolabs Inc.  They claim a 99.9% accuracy in guessing the sex of your baby as soon as 5 weeks after conception.  Due to patent issues, they claim, they are unable to share with anyone the data from where this accuracy was calculated.  Statistically, how many tests would have to be done to verify that they can significantly predict male, female or twins with a 99.9% accuracy?  Can't we test this biotech company to make sure they are not selling a bogus product.  

But kudos for their method of sidestepping the FDA.  Each day we in biotech attempt to create data that we think will satisfy the FDA.  They do not tell anyone ahead of time what to do so we fumble along looking for things we think will help our case.  The real skill then becomes how to avoid exposing bad data.  Randomness allows less than favorable data to be hidden.  Well thought our research leaves you wide open for failure.  And that is a bad business model.