is it possible to measure up to freelite · belgium, netherlands, luxembourg: the binding site...

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The Specialist Protein Company Is it possible to measure up to Freelite? N-Latex FLC Freelite NO FDA Regulatory Compliant YES NO IMWG Guidelines for Diagnosis 1 YES NO IMWG Guidelines for Monitoring 2 YES NO IMWG Guidelines for Prognosis 2 YES NO Identification of AKI MM 3 YES NO More than 10 years of clinical data YES <25 Provenance - publications >2,000 <7.5% 4 Consistency (batch to batch variation) <6% 5 YES Antigen Excess Protection YES 5% Antigen Excess Incidence 6 1% 0.940 Linearity 7 0.988 Limited Dedicated Global Technical Support YES 2 Range of Platforms >15 No Dedicated EQA Scheme YES <100% Sensitivity (LCMM) 8 100% Freelite outweighs the competition Free Light Chain Assays for Multiple Myeloma The GOLD STANDARD from Binding Site

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Page 1: Is it possible to measure up to Freelite · Belgium, Netherlands, Luxembourg: The Binding Site SPRL/BVBA Belgium Tel: +32 (0)3 242 88 21 info@bindingsite.be Italy: The Binding Site

The Specialist Protein Company

Is it possible to measure up to Freelite? N-Latex FLC Freelite NO FDA Regulatory Compliant YES

NO IMWG Guidelines for Diagnosis1 YES

NO IMWG Guidelines for Monitoring2 YES

NO IMWG Guidelines for Prognosis2 YES

NO Identifi cation of AKI MM3 YES

NO More than 10 years of clinical data YES

<25 Provenance - publications >2,000

<7.5%4 Consistency (batch to batch variation) <6%5

YES Antigen Excess Protection YES

≤5% Antigen Excess Incidence6 ≤ 1%

≥0.940 Linearity7 ≥0.988

Limited Dedicated Global Technical Support YES

2 Range of Platforms >15

No Dedicated EQA Scheme YES

<100% Sensitivity (LCMM)8 100%

✓✓

✓✓✓✓

✓✓

✗✗✗✗✗✗

Freelite outweighs the competition ✓

Free Light Chain Assays for Multiple Myeloma

The GOLD STANDARD from Binding Site

Free Light Chain Assays for Multiple Myeloma

Page 2: Is it possible to measure up to Freelite · Belgium, Netherlands, Luxembourg: The Binding Site SPRL/BVBA Belgium Tel: +32 (0)3 242 88 21 info@bindingsite.be Italy: The Binding Site

References:

1 Rajkumar SV, et al. Lancet Oncol 2014; 15: E538-482 Dispenzieri A, et al. Leukemia 2009; 23: 251-2243 Hutchison CA, et al. Nature Rev Nephrol 2012:8 (1) 43-514 Siemens data “Add Consistency to Your Results” 05-20125 Binding Site data APDOC046 Burden JM, et al. presented at AACC 20127 Sharrod-Cole H, et al. Biochimica Clinica 2013; 37:T390a8 Drayson M, et al. Clin Lymphoma Myeloma 2009; 9: A346a

Freelite, SPAPLUS & Optilite are registered trademarks of The Binding Site Group Ltd (Birmingham, UK) in certain countries.

BNTMII is a trademark of Siemens Healthcare Diagnostics Inc.

Go to www.bindingsite.com to contact us in over 80 countries. www.bindingsite.com

Head Office:The Binding Site Group LtdUnited KingdomTel: +44 (0)121 456 [email protected]

USA, Canada, Latin America:The Binding Site Inc.USAToll Free: 800 633 [email protected]

Germany, Austria, Switzerland:The Binding Site GmbHGermanyTel: +49 (0)6202 9262 0 [email protected]

France:The Binding Site FranceFrance Tel: +33 (0)[email protected]

Spain:The Binding Site SpainSpainTel: +34 934676539 [email protected]

Czech Republic, Slovak Republic:The Binding Site s.r.o.Czech RepublicTel: +420 223 013 988-9 [email protected]

January 2015

MKG786.EBelgium, Netherlands, Luxembourg:The Binding Site SPRL/BVBABelgiumTel: +32 (0)3 242 88 [email protected]

Italy:The Binding Site ItalyItalyTel. +39 035 [email protected]

Freelite® N-Latex

System Optilite® SPAPLUS® BNTMII

κ λ κ λ κ λ

Measuring range mg/L 2.9-127 5.2-139 4.0-180 4.5-165 3.5-110 1.9-60

Sensitivity mg/L 0.58 1.3 0.4 0.45 0.175 0.475

Within run precision <5.2% <3.4% <3.3% <3.7% <5% <5%

Between run precision <2.9% <4.2% <4.2% <5.7% <6.5% <6.5%

Calibrator dilution Onboard Calibrator set Onboard

On board stability days 30 40 25

Automatic antigen excess check Yes Yes Yes

Time to first result 17mins 14mins 15mins

Throughput for 60 samples* 1hr 35mins 2hrs 33mins 3hrs 20mins

*Time taken from first result to last for 40 Multiple Myeloma and 20 normal samples run against both kappa and lambda.

The facts? See the difference a Binding Site system makes!