Specialised study management and data capture for genetox assays

Many the world’s leading pharmaceutical and contract research organizations use Cyto Study Manager to help them increase productivity and improve compliance with GLP regulations. Compatible with all types of study designs and offering flexible, customizable reporting, Cyto Study Manager can be used ‘out of the box’ with the following assays.

  • Ames in-vitro assay
  • Comet in-vitro and in-vivo assay
  • Micronucleus in-vitro and in-vivo assay
  • Chromosome Aberrations in-vitro and in-vivo assay
  • Neutral Red Uptake in-vitro assay
  • Transgenic Rodent Assay (Watch Demo)

Because Cyto Study Manager has been designed to work with any assay that shows a dose-response relationship, we have experience in configuring the system to meet individual client needs. Email help@instem.com to discuss how your assay workflow could benefit from integrating your data acquisition, auditing, reporting and study management into one easy-to-use solution.

Ames Assay

  • Instant capture of automatic plate counts when combined with the Sorcerer Colony Counter – simply hit the space bar and the plate is automatically scored and data saved
  • Accommodates multiple experimental designs
  • Versatile sharing of concurrent controls
  • Plate observations for contamination, precipitation, manual count etc.
  • View and filter all historical controls data
  • Automatic generation of CTD (dose ascending or descending), OECD and Japanese reports included as standard
  • Reports can be customized to meet your needs

Chromosome Aberrations Assay

  • Suitable for in-vitro and in-vivo
  • Score total cells and all chromatid, chromosome, and other aberrations via an intuitive user interface
  • Customize the metrics you want to score and formula to include in your reports
  • Integrates with 4 or 8 button tally counters
  • Accommodates multiple experimental designs
  • Versatile sharing of concurrent controls
  • Ability to add individual sample, culture (vitro) or animal (vivo) comments and/or observations
  • Supports blind scoring via automated random culture/animal code generation, and slide coding and decoding (where appropriate)
  • View and filter all historical controls data
  • Automatic generation of reports showing cytotox, mitotic index, RICC/RPD polyploid and chromosomal aberrations data for chromosome aberrations in-vitro and OECD report for chromosome aberrations in-vivo included as standard
  • Historical control reports available for both in-vitro and in-vivo
  • Reports can be customized to meet your needs

Micronucleus Assay

  • Suitable for in-vivo and in-vitro
  • Score coulter counts, replication index and vitro/vivo micronucleus data
  • Customize the metrics you want to score and formula to include in your reports
  • Suitable for micronucleus flow: 96 well plate layouts included as standard, with ability to import data straight from your existing instrument
  • Integrates with 4 or 8 button tally counters
  • Accommodates multiple experimental designs: completely configurable plate layouts, ability to import data, or score manually – either with or without a tally counter
  • Versatile sharing of concurrent controls
  • Ability to add individual sample, culture (vitro) or animal (vivo) comments and/or observations
  • Supports blind scoring via automated random culture/animal code generation, and slide coding and decoding (where appropriate)
  • View and filter all historical controls data
  • Automatic generation of reports showing cytotox, CBPI and RICC/RPD data for micronucleus in-vitro & %PCE, and %MN-PCE for micronucleus in-vivo included as standard
  • Slide decoding, slide labelling and historical control reports available for both in-vitro and in-vivo
  • Reports can be customized to meet your needs

Comet Assay

  • Suitable for in-vivo and in-vitro
  • Automatic capture of key metrics: % Tail Intensity, Olive Tail Moment, and % Hedgehogs when combined with Comet Assay IV. Alternatively, you can quickly and easily import data from your existing instruments with just a few clicks.
  • Accommodates multiple experimental designs
  • Versatile sharing of concurrent controls
  • Slide observations for contamination, lost slide, not scorable, manual count etc.
  • Supports blind scoring via automated slide coding and decoding
  • View and filter all historical controls data
  • Automatic generation of comet data, slide decoding, slide labelling and historical controls reports for both in-vivo and in-vitro included as standard
  • Reports can be customized to meet your needs

Neutral Red Uptake Assay

  • Suitable for in-vitro
  • Effortlessly manage multiple plates and samples
  • Import data to CSM directly from your existing lab equipment
  • Plate layouts for OECD and Health Canada methodologies available by default
  • Accommodates multiple experimental designs with fully configurable plate layouts
  • Versatile sharing of concurrent controls
  • Ability to add individual sample or culture (vitro) comments and/or observations
  • View and filter all historical controls data
  • Automatic generation of OECD and Health Canada reports, including automatic calculation of relative survival rate, included as standard
  • Reports can be customized to meet your needs

Transgenic Rodent Assay

  • Suitable for in-vivo
  • Comprehensive support for the most common TRAs: MutaMouse and Big Blue
  • Easily manage data from all the different tissues in one place
  • Simple set up and tracking of DNA packaging locations
  • Data automatically flagged for review, sparing Study Directors from manually reviewing every line
  • Automatically report and run stats on mutant frequency
  • End result: Faster data interpretation and assay throughput

You work to GLP and so do our genetox solutions…

All of Instem’s genetox solutions are designed with reference to the OECD and S2(R1) guidelines. We ensure our solutions are fully compliant with the principles of Good Laboratory Practice (GLP) and the FDA 21 CFR part 11 rule on electronic signatures.

Regulatory Compliance

 

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