Healthcare%20And%20Medicine%20concept_ed

Early Stage

Our early stage services provide customers the tools for discovery and proof of their genetic algorithms. Most demand is for our bioinformatics capabilities within our genomics commercialisation framework.

Benefits available:​

  • onsite or hosted solutions available

  • file processing  and conversion eg.

    • FastA, FastQ, Big Wg, Bed, SAM, BAM,

    • SFF, SRF, GFF, GTF, MAF, EMBL

  • Automated pipelines for;

    • Exome

      • Alignment, SNP, indel,  SNV,  Visualisation, CNV

    • Whole Genome

      • Alignment, SNP, indel, SNV, Visualisation, CNV

    • RNA-Seq (alignment, fusion transcripts)

  • De Novo Assembly

Compliance%2520Rules%2520Law%2520Regulat

Compliance

Commercial operations of genetic diagnostics requires compliance with laws covering information privacy, security and breach reporting in most countries. Commercialising a genetic test will usually require compliance with these laws.

Common countries include;

 

  • USA - HIPPA, HITECH, Omnibus

  • Canada - PIPEDA

  • EU - General Data Protection Regulation (2018)

  • UK - NHS Act, Human Rights Act, Data Protection Act

  • Australia - Privacy Act

 

Implementation

Most genetic tests are developed through extensive bioinformatics work relying on many independent pieces of software connected as a workflow or pipeline of operations on the genetic data to finally arrive at the test outcome. In most cases these research pipelines will need to be repurposed or rewritten for use in a commercial clinical deployment. We will architect and develop the appropriate software pipeline to commercialise the test as a software medical device.

Scientist%20or%20student%20using%20%20la

Diagnostic Labs

Commercialising a genetic test will need the services of an accredited diagnostic pathology lab to process the biological samples of patients. The lab may also sell the test as part of its own service offerings. We are able to utilise our partner labs to to work with customers  to access  global markets.

Business%20people%20shaking%20hands%2C%2

Capital Funding

Through our partnership with Parkway Bioventures we are able to fast-track our customers to be assessed for capital investment. The optimal profile for an investment target includes;

 

  • Early Stage

    • Bench proof of genetic test algorithm

    • Independent assessment and proof of algorithm

  • Mezzanine

    • Patent applications completed

    • Proven clinical utility

  • Commercial Ready

    • Clinical trials complete with successful outcomes

    • Medical device and other compliances ready for audit

    • Commercial models developed

Abstract%2520luminous%2520DNA%2520molecu

Clinical Systems Integration

Increasing demand for genetic tests will require wider risk protection and liability management because a significant part of the diagnostic procedure is bioinformatics and out of the wet lab. If you are a commercial pathology lab integrating genetic tests into your service offerings we can help.

 

  • Genetic test results in easy-to-use clinical reports

  • Dynamic live reports with drill-down into supporting information

  • Embedded information from public data sources

  • Integration with LIMS and other datastores

  • Audit compliant bioinformatics

  • Data and diagnosis replay

  • Encryption of data at rest, in transit and in use

  • Virtual Data Room (VDR) for collaborative diagnosis

Ampule%20on%20the%20table%2C%20negative%

Clinical Trials

Proof of clinical utility is the most critical requirement to proceed with commercialisation of a genetic test. We can help with locating the right practitioners and specialists who may support your test and agree to drive the trials. Through our various partners we provide additional support through software and services to manage the trials.​

Medical%20background_edited.jpg

Medical Device

In most countries the application of genetic tests for patient diagnosis and treatment is considered the use of a medical device. Depending on the country it will be classified as a Class 1, 2 or 3 medical device according to the risk of harm to a patient should the test malfunction in some way. We take you through medical device certification for

  • USA

  • Canada

  • Europe

  • Australia

Applied Precision Medicine brings together consultancy, implementation, and training to deliver genetic tests into commercial clinical use. Covering the continuum from scientific research to medical use needs a broad set of unique services and skills designed for customers at various stages of this journey.