US 12,613,190 B2 · Quantitative liquid biopsy diagnostic system and methods

Abstract

The present invention provides a quantitative liquid biopsy diagnostic system and methods for performing diagnostic assays. The system offers a liquid biopsy method using circulating tumor cells (CTCs) or White Blood Cells (WBC) subpopulations for precision cancer diagnosis, early detection of disease evolution, and cancer patient management. The invention utilizes selective plane illumination microscopy (SPIM) to deliver high sensitivity and specificity for the detection and isolation of individual CTCs, superseding the efficacy of existing methodologies for early cancer detection. Isolated CTCs can be analyzed for their molecular fingerprint, which can lead to matching genetic abnormalities with specific drug treatments. The system allows ex vivo observation of live CTC or WBC response to treatment. This observation of live cells offers the oncologist a new potential for optimizing therapeutic protocols by testing a patient's own cells, and then administering treatment to the patient with the expectation of improving efficacy and reducing toxicity to normal cells.

Claims13

Dependent claims

A method for characterizing or quantitating target cells in a blood sample, the method comprising:

(a) obtaining the blood sample from a subject,
(b) preparing the blood sample by performing (i) through (vi), to generate a prepared sample:
(i) centrifugation to separate cell layers from a blood serum layer of the blood sample,
(ii) removal of a layer of the cell layers,
(iii) suspension of the removed layer from (b)(ii) in a buffer,
(iv) purification of the suspended layer of (b)(iii),
(v) immobilization of the purified layer of (b)(iv), and
(vi) immunostaining or fluorescence in situ hybridization (FISH) staining of the immobilized layer of (b)(v),
(c) subjecting the prepared sample to selective plane image microscopy by scanning the prepared sample with a laser sheet light source at a plurality of cross-sections to obtain contiguous cross-sectional images,
(d) collecting a sufficient quantity of the contiguous cross-sectional images,
(e) compiling the contiguous cross-sectional images to produce a composite image, and
(f) assessing the composite image to characterize or quantitate the blood sample for the target cells.

9 more elements

Dependencies are inferred from the claim text.

Quantitative liquid biopsy diagnostic system and methods

Life of this patent

Quantitative liquid biopsy diagnostic system and methods

Life of this patent

Abstract

Claims13