Latest Point Of Care Diagnostics News

Nexsen Limited has reported significant progress in its rapid diagnostic technologies, including a key FDA pre-submission for its GBS rapid sensor and a solid cash reserve post-IPO to support commercialisation efforts.

Lumos Diagnostics reported a strong surge in FebriDx® sales alongside positive FDA feedback, securing full Medicare reimbursement and advancing key clinical studies.

Nexsen Limited has won a $500,000 non-dilutive grant to extend its rapid Group B Streptococcus diagnostic technology into neonatal care, opening a significant new market opportunity.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.

Nexsen Limited has appointed internationally acclaimed surgeon-scientist Professor Shekhar Kumta to its board, aiming to fast-track clinical validation and regulatory approval for its rapid diagnostic platforms ahead of a planned 2026 market entry.

Lumos Diagnostics has achieved a major milestone by securing 100% Medicare reimbursement recognition for its FebriDx test across all seven US Medicare Administrative Contractors, paving the way for broader adoption in the American healthcare system.

Nexsen Limited has successfully completed an $8 million IPO and ASX listing, while advancing its kidney diagnostic tests and initiating clinical trials for its GBS Rapid Sensor targeting expedited FDA approval.

Atomo Diagnostics reported strong commercial momentum in Q1 FY26, highlighted by a key FDA submission for its FebriDx test and a successful capital raise of $1.3 million. The company also showcased promising clinical data for its Active Syphilis test and expanded its HIV Self-Test distribution channels.

Archer Materials has successfully demonstrated that its blood potassium Biochip can be fabricated on a silicon platform, matching clinical accuracy standards and accelerating its path to commercialisation.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Atomo Diagnostics reported a 27% reduction in net loss to AUD 4.97 million for FY25, alongside a 7% revenue dip to AUD 3.79 million, driven by stronger margins and cost controls. The company also secured a significant US distribution contract through partner Lumos Diagnostics, positioning it for growth.

Lumos Diagnostics has submitted its CLIA waiver application for FebriDx® to the FDA, backed by strong clinical data and triggering significant milestone payments. Approval could expand the U.S. market opportunity fifteen-fold to over $1 billion.