PRASAD DEVARAJAN, M.D.
Medical Practice in Cincinnati, OH

2014008, Mar 20, 2014

Oct 3, 2013

14/044953

Prasad Devarajan - Cincinnati OH, US

CHILDREN'S HOSPITAL MEDICAL CENTER - Cincinnati OH

G01N 33/68

435 23

A method for the detection of an early biomarker for assessing a change in renal status in a mammalian subject following a renal event. The method typically includes the steps of (a) providing a body fluid sample obtained from a mammalian subject; (b) analyzing the molecular weight of the proteins in the sample using proteome analysis; and (c) identifying the presence of a protein in the sample selected from the group consisting of a 6.4 kDa protein, a 28.5 kDa protein, a 33 kDa protein, a 44 kDa protein, a 67 kDa protein, and combinations thereof. The presence of one of these proteins can serve as an early biomarker for assessing a change in renal status. The levels of these proteins can be compared to predetermined levels, and thus provide a determination of the subject's renal status. The invention also includes a method of assessing the administration of aprotinin during cardio-pulmonary bypass surgery and provides for methods where the level of the 6.4 kDa biomarker in the subject's urine directs a caregiver's therapeutic decision regarding the intra-operative administration of aprotinin.

7977110, Jul 12, 2011

Jun 21, 2008

12/143769

Jonathan Matthew Barasch - New York City NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US

Children's Hospital Medical Center - Cincinnati OH
The Trustees of Columbia University - New York NY

C12Q 1/25, G01N 33/53

436 96, 435 4, 435 79

A method for distinguishing between kidney dysfunctions in a mammal, including pre-renal azotemia, an acute renal injury that may progress to acute renal failure, and chronic kidney disease, using a urinary or circulating NGAL assay result that is compared to a predetermined NGAL cutoff level, and a single serum or plasma creatinine measurement. Typically the single creatinine measurement cannot distinguish acute renal injury from chronic kidney disease or pre-renal azotemia, a single measurement of urinary NGAL, combined with the single serum or plasma creatinine measurement, has sufficient sensitivity and specificity to distinguish acute renal injury from normal function, prerenal azotemia, and chronic kidney disease and predicts poor inpatient outcomes. Patients admitted to the emergency department of the hospital with any of acute kidney injury, prerenal azotemia, chronic kidney disease, or even normal kidney function, can be evaluated based on the single measurements of urinary or circulating NGAL, and serum or plasma creatinine. Urinary NGAL level is highly predictive of clinical outcomes, including nephrology consultation, dialysis, and admission to the intensive care unit.

2014008, Mar 20, 2014

Nov 25, 2013

14/088638

Jonathan M. Barasch - New York NY, US
Prasad Devarajan - Cincinnati OH, US
Thomas L. Nickolas - Brooklyn NY, US
Kiyoshi Mori - Kyoto, JP

G01N 33/68

435 792, 436501

Methods of assessing the ongoing kidney status in a subject afflicted with chronic renal failure (CRF) by detecting the quantity of Neutrophil Gelatinase-Associated Lipocalin (NGAL) in fluid samples over time. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the urine and serum as a result of chronic renal tubule cell injury. Incremental increases in NGAL levels in CRF patients over a prolonged period of time are diagnostic of worsening kidney disease. This increase in NGAL precedes and correlates with other indicators of worsening CRF, such as increased serum creatinine, increased urine protein secretion, and lower glomerular filtration rate (GFR). Proper detection of worsening (or improving, if treatment has been instituted) renal status over time, confirmed by pre- and post-treatment NGAL levels in the patient, can aid in designing and/or maintaining a proper treatment regimen to slow or stop the progression of CRF.

2012002, Feb 2, 2012

Oct 12, 2011

13/271588

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan M. BARASCH - New York NY, US

G01N 33/53

436501

A method and kit for detecting the early onset of renal tubular cell injury, utilizing NGAL as an early urinary biomarker. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the urine following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctate cytoplasmic distribution reminiscent of a secreted protein. The appearance of NGAL in the urine is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.

2010004, Feb 25, 2010

Oct 22, 2009

12/604117

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan M. Barasch - New York NY, US

C12Q 1/37

435 23

A method and kit for detecting the immediate or early onset of renal disease and injury, including renal tubular cell injury, utilizing NGAL as an immediate or early on-set biomarker in a sample of blood serum. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the blood serum following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctuate cytoplasmic distribution reminiscent of a secreted protein. The appearance NGAL in the serum is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.

2008001, Jan 17, 2008

Jun 28, 2007

11/770372

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan BARASCH - New York NY, US

C12Q 1/37

435023000

A method and kit for detecting the immediate or early onset of renal disease and injury, including renal tubular cell injury, utilizing NGAL as an immediate or early on-set biomarker in a sample of blood serum. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the blood serum following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctuate cytoplasmic distribution reminiscent of a secreted protein. The appearance NGAL in the serum is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.

2011024, Oct 6, 2011

May 21, 2010

12/785220

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan M. Barasch - New York NY, US

G01N 33/53, C07K 16/22

435 792, 5303881

A method and kit for detecting the immediate or early onset of renal disease and injury, including renal tubular cell injury, utilizing NGAL as an immediate or early on-set biomarker in a sample of blood serum. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the blood serum following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctuate cytoplasmic distribution reminiscent of a secreted protein. The appearance NGAL in the serum is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.

2013029, Nov 7, 2013

Mar 14, 2013

13/804169

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan M. Barasch - New York NY, US

G01N 33/74

435 792, 436501, 4352872, 422430

Use of serum neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker, alone or in conjunction with creatinine to aid in the diagnosis of renal conditions such as acute tubular necrosis and acute renal failure, and a method and a kit for assigning a diagnosis of acute tubular necrosis or acute renal failure to a subject based on the correlation between the levels of NGAL and optionally creatinine in a sample obtained from a subject when compared to a sample obtained from a normal subject not experiencing acute tubular necrosis or acute renal failure.

2010002, Feb 4, 2010

Sep 25, 2009

12/567058

Prasad DEVARAJAN - Cincinnati OH, US
Jonathan M. Barasch - New York NY, US

G01N 33/53

435 792

A method and kit for detecting the immediate or early onset of renal disease and injury, including renal tubular cell injury, utilizing NGAL as an immediate or early on-set biomarker in a sample of blood serum. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the blood serum following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctuate cytoplasmic distribution reminiscent of a secreted protein. The appearance NGAL in the serum is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.