Atomo Diagnostics Limited (ASX:AT1) has announced a positive update regarding its Pascal test cassette. Atomo is an Australian headquartered medical device company supplying unique, integrated rapid diagnostic test (RDT) devices to the global diagnostic market. The company’s Pascal cassette performed exceptionally well in US clinical studies supporting a CLIA waiver submission for Lumos Diagnostics’ FebriDx test.
The FebriDx test, which has already secured 510k clearance from the US FDA using the Pascal cassette, recently completed a CLIA waiver trial and submission to the US FDA. Results showed greater than 99% concordance between trained and untrained operators, highlighting the usability and reliability of the Pascal cassette. This milestone is expected to significantly boost demand for FebriDx.
Atomo anticipates substantial revenue growth based on the CLIA waiver and contracted minimum order quantities between Lumos and PHASE Scientific, who have a six-year exclusive U.S. distribution agreement for FebriDx. Pascal cassette orders are expected to reach up to US$6.9 million (A$10.7 million) over the first three years of the contract. These figures materially exceed contract minimums and reflect the scale of the agreement now in place for FebriDx in the US.
Lumos previously indicated that its agreement with PHASE could generate FebriDx product sales of up to US$313.5 million over the six-year term, contingent on the CLIA waiver being granted and contracted minimum order quantities being achieved. Atomo and Lumos are also discussing supply of Pascal cassettes for the PHASE agreement, which is expected to be in addition to the revenues detailed above. Managing Director John Kelly expressed his delight in the level of performance that the integrated Pascal cassette delivers to partners seeking to secure approvals for tests in CLIA waived and Self-Test markets.
