June 29, 2015
Sekisui Medical Co., Ltd.

"Norudia^® L-FABP", a new reagent for the detection of "Liver-type Fatty Acid Binding Protein" (L-FABP), a protein found in urine, will be released on June 30th by Sekisui Medical (President: Hideo Tagashira; Head Office: Tokyo, Chuo Ward).

The level of L-FABP present in urine reflects the level of renal tubular dysfunction. Accordingly, L-FABP has recently been identified as a biomarker of renal illness in Japan, where it has garnered attention for its clinical significance in the identification of the renal damage caused by diseases such as septicemia and drug-induced nephropathy, post-operative renal damage following cardiovascular surgery, in addition to chronic kidney diseases such as diabetic nephropathy.

"Norudia^® L-FABP" is a latex agglutination turbidimetric reagent, available for use on a wide variety of general purpose auto-analyzers. Until now, analysis of L-FABP levels has required 2 - 3 hours. However, with this product that time has shrunk to 10 minutes, meaning results will be available to hospital laboratories rapidly, especially important for the rapid diagnosis of acute renal failure.

In the area of Renal Disease Assays, Sekisui Medical currently offers tests for urine microalbumin and cystatin C, which can be used on a wide variety of biochemical analyzers. With the addition of "Norudia^® L-FABP" to our lineup, Sekisui Medical hopes to contribute further still to the diagnosis of renal disease.

For Reference:

1. 1Clinical Significance of Urine L-FABP Levels

   L-FABP is a 14 kDa, soluble protein expressed in the renal proximal tubules which are responsible for the reabsorption function of the kidney, and plays a critical role in both the energy and lipid metabolism that occurs there. L-FABP is expressed at higher levels when the proximal tubules undergo ischemia or oxidative stress and as a result is present in higher levels in excreted urine. Making use of this fact, L-FABP can be used as a biomarker to determine levels of renal stress, before it progresses to tissue damage.

2. 2Product Overview

   Product Name: Norudia^® L-FABP
   Intended Use: For determination of the levels of liver-type fatty acid binding protein (L-FABP) in urine.
   Analysis Principle: Latex agglutination turbidimetry
   Measurement Range: 1.5 - 200 ng/mL
   Sample Type: Spot Urine or Collected Urine (excluding acidified samples and samples containing toluene)

Packaging & Pricing:

Product Name		Package Contents	Recommended Retail Price (Excl. Tax)
Norudia® L-FABP	L-FABP Buffer ①	18mL x 1	¥240,000
	L-FABP Latex Test Solution ②	7mL x 1

These reagents are available in a variety of kit types. Please contact us for further details.

Sold Separately*
Product Name - Package Contents - Pricing

Product Name	Package Contents	Recommended Retail Price
L-FABP Calibrator	1 mL x 5 Conc. Levels x 1	¥22,000
L-FABP Control	1 mL x 2 Conc. Levels x 3	¥10,000

• *These products are not for in vitro diagnostic use.

1. 3Properties
   1. 1Can be used on general purpose automatic analyzers.
   2. 2Available as a liquid reagent, no need for dilution or reconstitution.
   3. 3No need for pre-treatment of samples, simply apply urine directly.
2. 4Product Pictures