Biomarkers for detection and diagnosis of head and neck squamous cell carcinoma

Abstract

Novel, sensitive and specific markers and methods for diagnostics and monitoring of head and neck squamous cell carcinoma (HNSCC) are provided. Kits and methods for the use of hyaluronic acid, hyaluronidase and CD44 to diagnose HNSCC are described.

1 - 12 . (canceled) 
     
     
         13 . A kit for diagnosing head and neck squamous cell carcinoma (HNSCC), the kit comprising a reference sample of at least one biomarker selected from the group consisting of hyaluronic acid (HA), total protein and hyaluronidase (HAase), and means for detecting/measuring said biomarker(s). 
     
     
         14 . The kit of  claim 13 , additionally comprising a reference sample of CD44 and a means for detecting/measuring CD44. 
     
     
         15 . The kit of  claim 13  that additionally comprises means for measuring total protein. 
     
     
         16 . The kit of  claim 13  that additionally comprises a substrate or container for holding a biological sample from a subject. 
     
     
         17 . The kit of  claim 14  that comprises reference samples of total protein and CD44 and means for measurement/detection thereof. 
     
     
         18 . The kit of  claim 17  that comprises at least one colorimetric agent for the detection of a biomarker. 
     
     
         19 . A kit for diagnosing head and neck squamous cell carcinoma (HNSCC) in a subject, the kit comprising:
 (a) a substrate for holding a saliva sample isolated from the subject,   (b) a plurality of biomarkers selected from the group consisting of HA, HAase, total protein and CD44;   (c) agents for detection/measurement of said biomarkers; and, optionally   (d) printed instructions for reacting the agents with the biological sample or a portion of the biological sample to detect the presence or amount of at least one biomarker in the biological sample.   
     
     
         20 . The kit of  claim 19  that additionally comprises means for measuring total protein in the saliva sample. 
     
     
         21 . The kit of  claim 19  wherein at least one agent is a colorimetric agent. 
     
     
         22 . The kit of  claim 19 , wherein the kit comprises antibodies specific for anyone or more biomarkers selected from the group consisting of hyaluronic acid (HA); hyaluronidase, total protein and CD44. 
     
     
         23 - 42 . (canceled) 
     
     
         43 . A panel of biomarkers comprising a plurality of biomarkers selected from the group consisting of hyaluronic acid, total protein, hyaluronidase, and CD44.