Genetic Signatures Limited


Developer and commercialiser of a nucleic-acid simplification platform and associated multiplex real-time PCR workflows for infectious disease screening. Operates R&D, validation and production laboratories, produces sample processing reagents and assays, supports automated extraction/PCR workflows and distributes products via a global network. Holds a patent portfolio covering its nucleic‑acid simplification technology and has completed regulatory clearances for at least one diagnostic kit in the US.

Industries

biotechnology

Nr. of Employees

small (1-50)

Genetic Signatures Limited

Headquarters: Newtown, Sydney, Australia (company research & development and validation laboratories). Production facility: Maroubra, Sydney, Australia.


Patents

Molecular detection assay using direct treatment with a bisulphite reagent

US-9732375-B2

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Enzymes for amplification and copying bisulphite modified nucleic acids

US-8685675-B2

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Methods for simplifying microbial nucleic acids by chemical modification of cytosines

US-8598088-B2

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Isothermal strand displacement amplification using primers containing a non-regular base

US-8431347-B2

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Assay for screening for potential cervical cancer

US-8343738-B2

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Nucleic acid detection assay

US-7846693-B2

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Products

Multiplex pathogen detection kits (multiplex real-time PCR)

Kits that enable simultaneous detection of multiple infectious pathogen targets using multiplexed real-time PCR workflows compatible with the company’s nucleic-acid simplification method.

Sample processing kits and conversion reagent

Sample processing kits that lyse specimens and isolate nucleic acids (DNA and RNA), and a bisulphite-based conversion reagent used to simplify nucleic-acid sequences prior to PCR.

Analyte specific reagents (ASRs) for research use

Reagent products provided for research applications; in some markets these are designated as research-use-only and not for in vitro diagnostic use.

Automated extraction and PCR setup platform (high-throughput)

Integrated platform for automated sample extraction and PCR setup with features for traceability, reduced reagent waste and a small laboratory footprint; supports high-density plate formats.

Automated result-calling software with LIS integration

Software that interprets PCR output, provides easy-to-interpret calls, prints reports and integrates with laboratory information systems; validated on common PCR instruments.


Services

Development of laboratory protocols, access to performance materials and clinical samples, and on-site/regional training for customers and distributors.

Expertise Areas

  • Molecular diagnostics development
  • Syndromic multiplex PCR assay design
  • Reagent formulation and clinical kit manufacture
  • Laboratory automation and workflow integration
  • Show More (3)

Key Technologies

  • Bisulphite-mediated nucleic acid simplification (3-base conversion)
  • Multiplex real-time PCR (qPCR)
  • Automated nucleic acid extraction and liquid handling
  • High-throughput 384-well PCR workflows
  • Show More (4)

News & Updates

Secured lab space and operations support at BioHub Birmingham to support protocol development, access to clinical samples, customer training and technical support in the UK/Europe.

A gastrointestinal parasite detection kit based on the company's nucleic-acid simplification and multiplex PCR workflow received FDA 510(k) clearance for sale in the United States.

Production team expanded since 2020 to meet increased demand (including COVID-19 related demand) and to support global supply requirements.


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