DName-iT MEDICAL CLASSIFICATION PAVES THE WAY FOR COMMERCIAL DEVELOPMENT

DName-iT Holdings Limited (or ‘the Company’), backed by EMV Capital plc, is proud to announce that its DName™ platform has achieved Class 1 medical device registration in both the UK and EU. These registrations mark a milestone moment for the Company, as it means DNames™ and their companion DName-iT software can be marketed and sold in two important regions. 

The DName™ platform is the Company’s proprietary technology that has been developed for use in the $13.5Bn (2024 estimate[1]) Next Generation Sequencing (or ‘NGS’) DNA analysis industry.  DNamesTM are manufactured DNA barcodes that can be added to patient samples - blood, saliva and extracted DNA. DNamesTM  can then be detected in NGS results, allowing samples to be traced through tests. NGS involves pooling many patient samples at a time for economic processing, opening up the possibility of handling errors and contamination. 

The Company’s patent-protected 2-Step PCR indexing[2] and barcode preparation[3] methods mean DName™ barcodes can be generated cost-effectively in huge numbers from relatively few DNA components. DName-iT’s software focuses on the DNames™ barcode data in NGS results and does not impact or analyse patient-specific DNA data, maintaining test validity, patient privacy and confidentiality.

DNames™ analysis in test results allows a wide range of errors to be detected - sample swaps and cross-contamination, reagent contamination and index-hopping. The Company’s technology can be used to protect against these problems, providing laboratories and their customers with a competitive advantage through ‘quality assurance’ for clinicians and patients.

Pre-analytical errors, including those detected using DNames™, account for 60-70% of all laboratory errors[4].  The importance of accurate, trustworthy DNA sequencing results is vital, with dramatic increases in the use of pooled NGS for Non-Invasive Prenatal Tests (or ‘NIPT’) and in cancer investigations. Clinicians need high confidence in both the traceability of test results and their interpretation of data, including mutations. The Company’s own research estimates that the US and EU market for DNames™ is currently worth $25m+ pa for NIPT and cancer tests alone.

The Company is now advancing its commercial strategy, in parallel with further product development and testing, with the confidence of EU and UK medical device registration for the DName™ platform.

Kevin Dean, CEO of DName-iT Holdings Limited commented:

“This is a significant milestone for DName-iT, as it allows us to start on our roadmap to commercialisation. We are excited to expand DName-iT and to make a meaningful contribution to the quality of healthcare by enabling traceability of NGS test results for both patients and their clinicians. Our technology has particular implications for Non-Invasive Prenatal Tests and in cancer investigations, where clinicians need high confidence in both the traceability of results and the insights they can derive from NGS output data. With this certification we are set to accelerate our commercialisation strategy, begin on our go-to-market activity and drive the adoption of DNames™ as the gold standard for NGS testing.”

[1] Source: Frost & Sullivan

[2] Europe: EP 2,201,143 B2; USA: US 8,318,434 B2; and Canada: CA 2,697,640 C

[3] China: CN 109,477,141 B; Japan: JP 7,071,341 B2; India: IN 2023,475,750 B; 

Europe: EP 3,458,606 A1; USA: US 2019,300,948 A1; Canada: CA 3,024,355 A1;

Korea: KR2023,0065,357 A; and Australia: AU 2023,229,558 A1   

[4] Nordin et al, PubMed 2024