Method for validating assays of biological samples

A method of validating a patient-specific oligo, the method comprising:

• extracting DNA or RNA from a patient sample to produce a DNA or RNA sample;
• introducing a plurality of sets of spike-in sequences into the DNA or RNA sample to produce a spiked sample, wherein the plurality of sets of spike-in sequences comprises spike-in sequences of known concentrations;
• assaying the spiked sample with synthesis-control oligos and patient-specific oligos to produce a read out of the counts of the set of spike-in sequences and detect the patient-specific RNA or DNA;
• and
• comparing the counts from the set of spike-in sequences with the known concentrations of the spike-in sequences to provide dose-response characteristics of the synthesis control oligos which thereby serve as proxies for the dose-response characteristics of the patient-specific oligos.