End-to-End Pathology Services
HOLISTIC DELIVERY OF HIGH-COMPLEXITY CLINICAL TESTING
Our Approach. Relationship Driven. Results Oriented.
Nexomics is an integrated service within the Department of Pathology at Peter Mac committed to facilitating end-to-end, comprehensive pathology management solutions for all stages of clinical trial development.
These Include a range of clinical testing and trial support services:
- Comprehensive oncology test offering
- Bespoke test validation and development with TGA/NATA accreditation (ISO15189) across various methodologies e.g. IHC, ELISA and flow cytometry
- Study specific project management and delivery
- Test request forms for clinical trials, drug-access programs and retrospective testing
- Centralised collection kit production and global supply
- Sample collection, management and tracking
- Sample logistics and short-term storage
- Clinical report generation and distribution
- Clinical trial testing data extraction
Comprehensive ONCOLOGY SERVICES to support CLINICAL TRIALS
Integrated Pathology for Precise Diagnostics.
Delivering accurate testing and interpretation for clinicians, clinical researchers and commercial clients delivering accurate diagnoses and relevant prognostic information for a wide range of haematologic diseases across various assay methodologies including specialised bone marrow reporting, flow cytometry and next-generation sequencing.
Our extensive portfolio includes routine diagnostic molecular pathology testing, alongside a comprehensive array of fluorescence in situ hybridisation (FISH), germline, somatic, ctDNA, cfDNA, qPCR, ddPCR and NGS sequencing assays tailored to meet the demands of clinical trials. We are committed to innovation and excellence, ensuring that our assays are at the forefront of scientific advancement.
Our extensive portfolio includes routine diagnostic molecular pathology testing, alongside a comprehensive array of fluorescence in situ hybridisation (FISH), germline, somatic, ctDNA, cfDNA, qPCR, ddPCR and NGS sequencing assays tailored to meet the demands of clinical trials. We are committed to innovation and excellence, ensuring that our assays are at the forefront of scientific advancement.
QUALITY RESULTS. PRECISION PATHOLOGy.
NATA | ISO 17025 and 15189 Accreditation
Nexomics at Peter Mac is accredited by Australia’s National Association of Testing Authorities (NATA) for compliance with the requirements of Good Laboratory Practice (GLP), as well as Good Clinical Laboratory Practice (GCLP), ISO/IEC 17025 and 15189.
- Our offering includes oncology specific testing services accredited by NATA ISO/IEC 15189 and 17025, conducted in specialised, cutting-edge laboratories.
- Our general pathology laboratory is NATA ISO/IEC 15189: 2022 accreditation for comprehensive molecular genetic testing.
- Our rigorous quality management systems guarantee that the data produced meets the stringent standards mandated by regulatory authorities.
- Bespoke assay development and method validation adhering to ICH and FDA standards.
- Provides transparency in our services through regular internal and external quality audits.
- Provides support for Medical Services Advisory Committee submissions for and Medical Benefits Schedule item number applications.
Frequently Asked Questions (FAQs)
Send us a message via our contact form detailing your specific requirements and questions and a member of our team will be in touch.
Who is nexomics and what do they offer?
nexomics is an expert contract service provider offering comprehensive, specialised oncology testing solutions. Our services are embedded within Peter MacCallum Cancer Centre, backed by pathologists, driven by our expert scientific and dedicated clinical trials team offering end-to-end pathology testing solutions to support clients through all stages of clinical development from early to late-stage clinical studies (Phase I to IV).
How does nexomics fit in with Peter MacCallum Cancer Centre?
Our services are powered by Peter MacCallum Cancer Centre (Peter Mac), backed by pathologists, driven by our expert scientific and dedicated clinical trial team.
Together we support CROs, clinical researchers, pharmaceutical and biotechnology clients through all stages of clinical development from early to late-stage clinical studies (Phase I to IV), ensuring seamless transition from initial inquiry through to study delivery.
Is your laboratory CAP / CLIA accredited?
Our laboratories are accredited by NATA (National Association of Testing Authorities) Australia’s leading national accreditation body and comparable to CLIA. NATA is recognised by government to assess organisations against a number of international standards for laboratories, inspection bodies, proficiency testing providers and reference material producers. Our accreditation covers both ISO15189 and IS017025.
Does nexomics provide testing services to support regulatory submissions?
Yes, nexomics offers compliant testing for regulatory submissions, including those for the FDA and TGA. Our ISO 15189 accredited testing services span anatomical pathology, haematopathology, immuno-oncology, and molecular pathology, encompassing a range of agnostic methodologies. We encourage biotechnology, and pharmaceutical companies requiring validation of translational assays to contact our team for detailed information on how our services can support their regulatory and patient access objectives.
