News & Topics

Aug 27, 2012

Release of the Gene Analyzer i-densy™ IS - 5320:
Realizing fast & simple gene testing with full automation

ARKRAY, Inc. (headquarters: Kyoto City, Nakagyo Ward), a manufacturer of sample test devices and in vitro diagnostic reagents, is set to release the i-densy™ IS - 5320 gene analyzer on Tuesday 28 August. The i-densy™ IS - 5320 is used for the fully automatic detection of genetic base pair sequences relating to the metabolism of drugs, as well as genetic mutations associated with cancer.

Background to release

Research into personalized medicine (in which the determination of the individual’s genotype forms the basis for optimum drug selection/ dosage according to that person’s body and the disease state) is progressing at a very fast pace.
However, this kind of pre-treatment diagnosis has typically been very difficult-to-perform, requiring a high degree of operational skill and a long period of time until results become available.
In 2009, ARKRAY released the i-densy™ IS-5310, the world’s first fully automatic and desktop sized SNP*1 analyzer for research use. This analyzer is used for the fully-automatic detection of genetic base pair sequences relating to the metabolism of drugs, as well as genetic mutations associated with cancer. ARKRAY is moving forward with research mainly in the fields of drug efficacy and side-effects associated with anti-cancer treatments, and continues to support research facilities around the country.

Outlook for the future

The medical-use gene analyzer i-densy™ IS-5320 is an improvement on and successor to the fully-automatic SNP analyzer i-densy™ IS-5310 (for research use).
Compatible in vitro diagnostic reagents were developed in parallel (with instrument development) for use on the i-densy™ IS-5320, allowing simple analysis of base pairs which in turn enables prediction of the effect of administered drugs as well as offering complementary diagnoses. We fully expect this system to contribute to speedy decision making, reductions in the rate of side effects and cost savings in the medical field.

Main features of the i-densy™ IS-5320

○Fully-automatic measurement
Simple measurement possible with no special skills required- just set the sample (blood or oral swab) Fully automatic in a single device: From DNA extraction from sample to gene amplification and on to gene type determination

○High speed measurement
Gene typing which previously took days from sample collection to output of results, now takes just 80 minutes

The Gene Analyzer i-densy™ IS-5320

Explanation of terminology

1) SNPs (Snips)
SNPs, also known as Single Nucleotide Polymorphisms: Minute changes occur in certain genes and when occurring in 1% or more of genetic base pairs, they are referred to as SNPs. Analysis of SNPs and their connection to drug efficacy and side effects, allows for selection of the most-appropriate treatment and dosage, as well as offering high hopes for personalized medicine in the medical field.

Operation method

Set the sample (blood or oral swab) in the pack, set the pack in the instrument and press the start button for rapid gene analysis.


Product outline


Gene Analyzer i-Densy IS - 5320

Release date

28 August 2012 (Tues)



Meas. sample type

Biological samples such as whole blood, purified nucleic acids

Measurement principle

Nucleic acid amplification + Tm analysis
*This system uses the QP (Quenching Probe) Method covered by a patent under license from Nippon Steel Kankyo Engineering, Co. Ltd.

Processing speed

80mins/ reagent pack *may vary depending on measurement item

Minimum sample volume

70µL of biological sample (whole blood etc), or 4µL of purified nucleic acid

No. of set samples

1-2 samples


100 measurements/ user (A maximum of 25 users may be registered)

Power supply

AC100, less than 300VA

Outer dimensions

410mm (Width) X 450mm (Depth) X 415mm (Height)



Medical device filing no.


Class categorization

Class I (General Medical Device)/ medical device with special maintenance controls

This product is available through ARKRAY, Marketing, Inc.; a member of the ARKRAY Group responsible for sales within Japanese.