Telo Genomics Corp. announced that it has recently completed the interim assessment of its systems and protocols for ISO 15189 certification with over 90% compliance. ISO 15189 is the international standard specific for clinical laboratories.

The completion of this critical step qualifies Telo to advance to the external audit stage, which is the final stage of the ISO certification process. In 2022, Telo began the adoption of the policies and the quality management system (QMS) required to qualify for ISO 15189. The process also included the implementation of a world class document control system and laboratory Information Management System (LIMS).

Achieving the ISO certification will allow Telo to offer laboratory developed tests ("LDT") commercially and issue patient reports nationally and internationally. The interim assessment was conducted by an external ISO consultant with over 15 years of experience of successfully guiding clinical laboratories through the ISO certification process. Telo expects the external audit to be completed by the end of the second quarter of 2023.

Telo's lead product is designed to identify high-risk smoldering multiple myeloma ("SMM") patients who are likely to benefit from earlier treatment intervention. The test also identifies the larger subset of low-risk SMM patients who have a more stable form of the disease and do not require immediate treatment. These patients can be regularly monitored using TeloView-MM.

There are approximately 200,000 SMM patients in the US that could benefit from the TeloView test and ongoing monitoring. The Company's second assay is designed to identify newly diagnosed multiple myeloma patients who are most likely to develop treatment resistance and relapse earlier than expected.