Theranostics platform and methods of use

1. A disease theranostics platform, comprising:

a. an automated cell-phenotype image-enhancing instrument for detecting an optically-visible disease cell-phenotype which is characterized by abnormal laminin binding, or abnormal lamin A/C or lamin B binding;

b. cells obtained or derived from a subject with the optically-visible disease cell-phenotype characterized by abnormal laminin binding, or abnormal lamin A/C or lamin B binding;

c. a drug/nutraceutical library; and

d. a computer-implemented system for analyzing responses of the optically-visible disease cell-phenotype of the cells obtained or derived from a subject with the optically-visible disease cell-phenotype to drugs or nutraceuticals from the drug/nutraceutical library, wherein the system comprises an algorithm for identifying drugs or nutraceuticals effective for normalizing or partially normalizing the optically-visible disease cell-phenotype.

2. The disease theranostics platform of claim 1 , wherein the automated cell-phenotype image-enhancing instrument is a microscope and detects the response of the optically-visible disease cell-phenotype to a drug or nutraceutical from the drug/nutraceutical library; wherein the microscope comprises:

a. detector for imaging the optically-visible disease phenotype;

b. magnification optics having sufficient magnifying power to visualize one cell in a plurality of cells; and

c. an available electronic memory for storing an image of a cell.

3. The disease theranostics platform of claim 1 , wherein the cells obtained or derived from a subject with the optically-visible disease cell phenotype are differentiated from a stem cell obtained from the subject with the optically-visible disease cell-phenotype, wherein said subject has symptoms of a disease associated with the optically-visible disease cell phenotype, has limited symptoms of the disease associated with the optically-visible disease cell phenotype or is asymptomatic, and the computer-implemented system comprises an algorithm that correlates the optically-visible disease cell-phenotype with the severity of the disease associated with the optically-visible disease cell phenotype in the subject.

4. The disease theranostics platform of claim 1 , wherein the drug/nutraceutical library comprises at least 500 commercially available nutraceuticals, approved therapeutic agents, or combinations thereof.

5. The disease theranostics platform of claim 1 , wherein the computer-implemented system comprises an algorithm that determines degrees of response of the optically-visible disease cell-phenotype to a drug or nutraceutical in the drug/nutraceutical library; and the computer-implemented system correlates the degree of response of the optically-visible disease cell-phenotype to the drug or nutraceutical in the drug/nutraceutical library with an effect of the drug or nutraceutical on at least one symptom of a disease associated with the optically-visible disease cell phenotype in vivo.

6. The disease theranostics platform of claim 1 , further comprising an assay for a biomarker that correlates with the optically-visible disease cell-phenotype, wherein the biomarker is present in blood, plasma, or cell culture medium.

7. The disease theranostics platform of claim 1 , wherein the optically-visible disease cell-phenotype comprises a fluorescent tag.

8. The disease theranostics platform of claim 1 , wherein the optically-visible disease cell-phenotype is cell morphology, nuclear morphology or morphology of any cytosolic organelle.

9. The disease theranostics platform of claim 1 , wherein the optically-visible disease cell-phenotype is associated with a disease, wherein the disease is laminopathy, Fukuyama congenital muscular dystrophy (FCMD), congenital muscular dystrophy unrelated to FCMD, Duchenne muscular dystrophy, Becker's muscular dystrophy, distal muscular dystrophy, Emery-Dreifuss muscular dystrophy, facioscapulohumeral muscular dystrophy, Limb-girdle muscular dystrophy, myotonic muscular dystrophy, oculopharyngeal muscular dystrophy, junctional epidermolysis bullosa, or nephrotic syndrome.

10. The disease theranostics platform of claim 1 , wherein the optically-visible disease cell-phenotype is associated with a rare disease, wherein the rare disease affects less than 200,000 persons in a United States population.

11. A method of identifying a drug or nutraceutical candidate for normalizing, or partially normalizing, an optically-visible disease cell phenotype which is characterized by abnormal laminin binding, or abnormal lamin A/C or lamin B binding in a subject in need thereof, comprising the steps of:

a. contacting a plurality of cells with the optically-visible disease cell phenotype with a drug or nutraceutical from a drug/nutraceutical library;

b. using an automated cell-phenotype image-enhancing instrument to obtain a magnified image of the plurality of cells following contact with the drug or nutraceutical from the drug/nutraceutical library, wherein the automated cell-phenotype image-enhancing instrument is configured for detecting the optically-visible disease cell phenotype characterized by abnormal laminin binding, or abnormal lamin A/C or lamin B binding; and

c. using a computer-implemented algorithm to analyze the magnified image to determine the response of the plurality of cells to the drug or nutraceutical from the drug/nutraceutical library;

wherein a drug or nutraceutical that normalizes or partially normalizes the optically-visible disease cell phenotype is identified by the computer-implemented algorithm as a candidate for normalizing, or partially normalizing the optically-visible disease cell phenotype in the subject in need thereof.

12. The method of claim 11 , wherein the subject in need thereof has symptoms of a disease associated with the optically-visible disease cell-phenotype, has limited symptoms of the disease or is asymptomatic.

13. The method of claim 11 , wherein the optically visible disease cell-phenotype is cell morphology, nuclear morphology or morphology of any cytosolic organelle.

14. The method of claim 11 , comprising using a microscope to obtain the magnified image of the plurality of cells.

15. The method of claim 11 , further comprising assaying for a biomarker that correlates with a disease phenotype associated with the optically-visible disease cell-phenotype, wherein the biomarker is present in blood, plasma, or cell culture medium.

16. The method of claim 11 , further comprising contacting the plurality of cells with a fluorescent tag to produce the optically-visible disease cell phenotype.

17. The method of claim 11 , further comprising using a computer-implemented algorithm to correlate the optically-visible disease cell-phenotype with a severity of the optically-visible disease cell-phenotype in vivo.

18. The method of claim 11 , wherein the optically-visible disease cell-phenotype is associated with a disease, wherein the disease is laminopathy, Fukuyama congenital muscular dystrophy(FCMD), congenital muscular dystrophy unrelated to FCMD, Duchenne muscular dystrophy, Becker's muscular dystrophy, distal muscular dystrophy, Emery-Dreifuss muscular dystrophy, facioscapulohumeral muscular dystrophy, Limb-girdle muscular dystrophy, myotonic muscular dystrophy, oculopharyngeal muscular dystrophy, junctional epidermolysis bullosa, or nephrotic syndrome.