Biodesix has created a set of analysis algorithms, collectively called ProTS®, which for the first time enables the reliable and routine use of matrix-assisted, laser desorption ionization (MALDI) mass spectrometry for clinical diagnostics. ProTS processes mass spectral data obtained from biological samples (blood, tissue, etc.), yielding spectra that can be reliably compared to one another. ProTS data analysis then identifies statistically significant features that differentiate the spectra from distinct clinical groups of samples. The selected features are incorporated into a novel classifier algorithm, which evaluates the spectra generated from a patient sample and assigns it to one of the distinct clinical groups (for example, those patients who respond well to a therapy and those who do not). The resulting tests are subsequently validated in separate studies using independent test sets.
The power of ProTS analysis has been demonstrated in the discovery of Biodesix’ first product — VeriStrat®, a clinically validated blood test that helps enable more informed decision-making by physicians for patients with advanced non-small cell lung cancer.
Compared with other biomarker discovery and diagnostic platforms, MALDI MS with ProTS offers the following important and unique advantages:
- an unbiased discovery method that does not require a preliminary hypothesis about specific differentiating proteins;
- a fast, versatile, and reproducible analytical method performed on easily-obtained samples without complicated pretreatment processes;
- a single platform used for discovery, validation and commercialization, that is not dependent on the existence of immunoassays.
At each stage of the process – discovery, validation, clinical use – the ProTS platform and the tests it produces offer speed and efficiency advantages over competing molecular diagnostics techniques.
To discuss ProTS for collaborative projects, please email: firstname.lastname@example.org