Periostin-based diagnostic assays

Abstract

The invention includes novel human periostin polypeptides and DNAs encoding them. Also embraced by the invention are human periostin specific antibodies, diagnostic assays for metastasis of breast cancer to bone, and preeclempsia.

1 .- 23 . (canceled)  
     
     
         24 . A method of diagnosing a metastasis of breast cancer to bone, the method comprising: 
 (a) identifying a breast cancer patient suspected of having or being at risk of having a metastasis of breast cancer to bone; and    (b) measuring the level of periostin in a sample of a body fluid from the patient, wherein an elevated level of periostin in the sample, compared to a control level of periostin, is an indication that the patient has a metastasis of breast cancer to the bone.    
     
     
         25 . The method of  claim 24 , wherein the body fluid is blood.  
     
     
         26 . The method of  claim 24 , wherein the body fluid is urine.  
     
     
         27 .- 40 . (canceled)  
     
     
         41 . The method of  claim 24 , wherein the measuring comprises contacting the sample with an antibody that binds to human periostin.  
     
     
         42 . The method of  claim 41 , further comprising, prior to contacting the sample with the first antibody that binds to human periostin, contacting the sample with a second antibody that binds to human periostin, wherein an epitope on human periostin to which the first antibody binds is not the same as an epitope to which the second antibody binds.  
     
     
         43 . The method of  claim 42 , wherein the second antibody is bound to a solid substrate.  
     
     
         44 . The method of  claim 41 , wherein the antibody is a polyclonal antibody.  
     
     
         45 . The method of  claim 41 , wherein the antibody is a mAb.  
     
     
         46 . The method of  claim 45 , wherein the mAb is a mAb that is secreted by the hybridoma 5H8 having ATCC accession no. PTA-4589.  
     
     
         47 . The method of claim  11 , wherein the mAb is a mAb that is secreted by the hybridoma 8H11 having ATCC accession no. PTA-4590.  
     
     
         48 . The method of  claim 42 , wherein the second antibody is a mAb.  
     
     
         49 . The method of  claim 48 , wherein the mAb is a mAb that is secreted by the hybridoma 5H8 having ATCC accession no. PTA-4589.  
     
     
         50 . The method of  claim 48 , wherein the mAb is a mAb that is secreted by the hybridoma 8H11 having ATCC accession no. PTA-4590.  
     
     
         51 . The method of  claim 42 , wherein the second antibody is a polyclonal antibody.  
     
     
         52 . The method of  claim 24 , wherein the method comprises an immunoblot assay.  
     
     
         53 . The method of  claim 24 , wherein the method comprises an ELISA assay.  
     
     
         54 . The method of  claim 24 , wherein the measuring step comprises measuring chemiluminesence.  
     
     
         55 . The method of  claim 24 , wherein the measuring step comprises measuring radioactivity or fluorescence.  
     
     
         56 . The method of  claim 24 , wherein the measuring step comprises measuring absorbance of visible or ultraviolet light.  
     
     
         57 . The method of  claim 41 , wherein the antibody is biotinylated.  
     
     
         58 . The method of  claim 24 , wherein the measuring step comprises the use of avidin.  
     
     
         59 . The method of  claim 24 , wherein the measuring step comprises the use of an antibody that binds to an immunoglobulin molecule.