Clinical trials

Molecular Services for Clinical Trials

Molecular methods are being increasingly embraced for clinical trial testing due to major benefits in information content, sensitivity, specificity and speed. GNOMIX is committed to collaborating with clinical researchers, CROs and clinical trial units to develop the best molecular testing options for their projects - keeping budgets and timeframe in mind. ** We always build you the BEST solution -not just whatever we have "on the shelf"
We begin with a simple discussion. Regardless of what phase the trial is up to, we can combine our decades of research and diagnostic expertise with yours to tailor a customised, end-to-end approach to deliver quality solutions.

Specimen storage and handling for clinical trials

Sample integrity from collection to delivery is paramount for optimal results. We can advise and suggest appropriate collection, storage and transport options including:
  • Best pre-transport aliquoting, temperature and labelling requirements
  • Trusted couriers we recommend, practised in temperature monitoring transit
  • Interstate and international shipping requirements
  • Ambient, refrigerated or frozen storage on site for the duration of the trial
  • Post-test redundancy banking available upon negotiation

DNA/RNA Extraction and Quality control

Whether you’re after DNA or RNA, on a scale small or large, we can extract from almost any biological sample. Blood, urine, faeces, swabs, fluids, tissue, tumours, FFPE, slides, saliva, cultured cells, single cells… you name it, we’ll extract it!
  • Our high-throughput automated equipment can handle large scale extractions of thousands of samples, while our team is also trained in a wide range of delicate, manual procedures
  • All of our extraction methods are run according to strict quality control policies to prevent contamination and to ensure the highest quality final products
  • Extractions can be thoroughly quantified and qualified via fluorometer, UV/VIS spectrophotometer, and/or capillary electrophoresis
For those difficult specimens
We have a broad range of automated instrumentation and speciality manual techniques for enriching and extracting rare sample types
  • Circulating Cell Free DNA (cfDNA)
  • Circulating Tumour Cells (CTC)
  • Antibody enrichment for specific cell types
  • Solid tissue dissociation into single cell suspension
  • Cryopreservation
  • Cell Fixation
  • Single cells from FFPE

PCR and sequencing technologies

We work with you to help decide which technologies might best suit your goals. Our options include, but aren’t limited to:
  • End-point PCR
  • Real-time / qPCR
  • Digital PCR
  • High resolution melt analysis
  • Standard gel electrophoresis
  • High resolution fragment size analysis
  • Sanger sequencing
  • Massively Parallel Sequencing (MPS) / Next Generation Sequencing (NGS) (MGI and Illumina)
  • Long Read Sequencing (Oxford Nanopore)

Flexible choice of Molecular Assays

From individual SNPs all the way up to exome or transcriptome analysis, we make sure the data you get is the data you want! Some of our fully customisable molecular assay options for clinical trials include:
  • Single gene analysis by Sanger sequencing
  • Genotyping by Fragment size analysis or Sanger sequencing
  • Single Nucleotide Polymorphisms (SNPs) by Sanger sequencing
  • Gene Panels (standard or custom; small to large) by MPS/NGS
  • Exome or Transcriptome sequencing
  • RNA sequencing (single gene, panel or transcriptome) by Sanger or MPS/NGS
  • Gene expression analysis (single gene, panel or transcriptome) by qPCR, digital PCR or MPS/NGS
  • Immune repertoire studies by MPS/NGS
  • HLA (Class 1 and 2) haplotyping
  • Microbiome analysis (16S or shotgun sequencing) by NGS/MPS or Long-read sequencing
  • Pathogen detection by qPCR or Sequencing

Secure and reliable data

You can rest assured your precious data is safe on our secure servers, protected by appropriate hardware and software firewalls, encrypted off-site backup and an uninterruptible power supply. Records will be securely retained on our systems according to ICH-GCP Guidelines for Good Clinical Practice; a minimum of 15 years after the trial has concluded. The form and presentation of your data is negotiable and tailorable to your clinical trials needs. We have multiple ways to securely transmit data promptly at prearranged timepoints.

Why choose us?

Good question! We work in a business where mistakes can be costly in many different ways. So who you choose to partner with is a very important decision
Our ethos is to work collaboratively with you to achieve your goals. To us, each client is individual with their own unique requirements. There is no "one size fits all" approach and we endeavour to provide a solution that is tailored to your question We are committed to continous improvement -the field doesn't stand still, and neither do we. We are constantly updating our technologies to stay at the forefront and offer state of the art options
The scale you want
Sledgehammers are not always best for cracking walnuts -but they also do have their uses. We provide flexible scaling of technologies to best fit your need
Quality and Speed
Timeframe can be just as important as the question itself. Our accredited quality system keeps things on track and on quality to meet your requirements
content you want
"But I only want the ones I'm interested in". No problem, we service gene lists of any size. These are negotiated with you
Expert consultancy
Sometimes you just want to know what is possible, what are your options, how to get there. Our team has decades of industry experience and loves to think outside the box. Let's talk!