Process for Preparation of a Biomarker Specific for O-acetylated sialic acid Useful for Diagnosing, Monitoring Treatment Outcome,  and Predicting Relapse of Lymphoblastic Leukemia

CSIR-IICB scientists have detected a novel biomarker specific for O-acetylated sialic acid in patients’ serum against 9-O-acetyl sialoglycocongugates which appeared on lymphoblasts. The selectivity of this biomarker specific for O-acetylated sialic acid has allowed not only the identification but also monitoring cancer cells using serum from the ALL patients.

The main objective of the present invention is to provide a process for the preparation of a novel biomarker specific for O-acetylated sialic acid useful for the diagnosis, monitoring outcome of treatment and prediction of relapse and biomarker prepared thereby which obviates the drawbacks of presently available methods. The invention also provides a process for the quantification of a novel biomarker specific for O-acetylated sialic acid present in the serum of ALL patient with the help of a simple, specific, sensitive, non-invasive and economical bovine submaxillary mucin ELISA which allows the assessment of the treatment outcome of ALL patients. This will specially be helpful for the detection of a novel biomarker specific for O-acetylated sialic acid which will reflect chemotherapeutic outcome in these children at different clinical stages of the disease. So, this invention provides an indicator as to when and how long should chemotherapy be continued and to predict the probability of relapse.

Preparation of a novel biomarker specific for O-acetylated sialic acid useful for the diagnosis, monitoring outcome of treatment and prediction of relapse of Acute lymphoblastic leukemia (ALL). 
The so generated reagent will serve as an effective measure in the battle for monitoring treatment outcome in patients suffering from acute lymphoblastic leukemia.

To provide a reagent, a novel biomarker specific for O-acety!ated sialic acid, by an simple process with a significant high yield. 
The reagent has an amplified biological potency to bind with cancer cells, therefore it has tremendous potential in terms of its detection capability of ALL patients under different phases of treatment eg. Potential for diagnosis and prognosis of ALL patients. 
Furthermore, the process for purification of a novel biomarker specific for O-acetylated sialic acid is not a complicated one and comprises only a few simple steps including removal of other non -O-acetylated proteins by using asialo bovine submaxillary mucin affinity column followed by capturing novel O-acetylated sialic acid specific biomarker using a bovine submaxillary mucin - Sepharose column. Thus a novel biomarker specific for O-acetylated sialic acid purified from these patients serum is of significant and maximum potency in detecting ALL patients under different phases of treatment i.e. detection of minimal residual disease in ALL, which is a challenging problem for leukemia specialist. 
To provide a reagent by a process" with a significant commercial application and can predict relapse. 
For diagnosis of ALL patients of different lineages e.g. T cell ALL, B cell ALL and mixed lineage ALL having cancer in both B and T lymphocytes by this novel biomarker specific for O-acetylated sialiclcid reflecting its general expression. 
It can distinguish between different stages of acute lymphoblastic leukemia which correlate well with the clinical status of the disease. 
It detects the extent to which the patient has responded to chemotherapy. 
Serum from other hematological disorder does not possess this biomarker 
Normal human serum contain very insignificant amount of this biomarker.