The Need

There is a major need for accurate quantification and detection of low frequency cancer mutations. Applications include cancer screening, drug development, treatment decisions, and cancer monitoring.

In cancer diagnostics misleading claims are rampant. Competitor will most often only list the sensitivity of the assay, instead of list the sensitivity and the specificity. A highly accurate assay needs to provide statistical confidence between a negative sample and a low positive.

In molecular diagnostics, DNA sequence is inferred not observed. Determining the DNA sequence of a target strand relies on a observing a marker, attached to a nucleotide. If an "G" is observed, then the sequence on the target strand is inferred to be a "C". However, DNA can mismatch, and sometimes that "G" did not bind to a "C", instead it bound to a "T". This mismatch binding is what causes noise/error/inaccuracy. 

Noise varies by system, with NGS and digital PCR around 0.1%. This means that tests cannot accurately detect a sample that is 0.01%, because the signal is below the noise.

How SentryDx using Bicycle PCR to address this issue of noise, is what allows Bicycle PCR to be much more accurate compared to competitors.