Latest ATOMO DIAGNOSTICS (ASX:AT1) News

Atomo Diagnostics stands to gain significantly as Lumos Diagnostics’ FebriDx test secures FDA CLIA waiver approval, vastly expanding its US market potential. This regulatory milestone triggers substantial contracted revenues and prompts Atomo to ramp up production.

Cancer drug data and two separate Mayo Clinic-linked deals drove the biggest moves this week. Investors paid up for clearer routes to hospital rollouts, while one digital screening name fell hard after early gains evaporated.

Atomo Diagnostics has responded to an ASX price query following unusual trading activity, denying any undisclosed price-sensitive information while acknowledging a related FDA update involving Lumos Diagnostics.

A single diagnostics update sparked a breakout week, while a handful of biotech names sold off hard despite busy newsflow. Capital raisings, takeover steps and US market pushes kept healthcare in motion heading into mid-February milestones.

Atomo Diagnostics has landed a significant $630,000 order to supply HIV self-tests for a federally funded Australian health initiative, reinforcing its role in expanding accessible testing.

A handful of healthcare names did the heavy lifting this week, driven by FDA wins, guideline upgrades, and big shifts in sales and cashflow. The flip side: several clinical-stage stocks fell hard as investors stayed picky about near-term proof and funding.

Atomo Diagnostics has secured a substantial A$416,000 order for its HIV Self-Test kits destined for an African country, marking its second Global Fund-backed contract this year and signalling growing global demand.

Atomo Diagnostics reported a robust 121% quarter-on-quarter revenue increase to $1.5 million, driven by new orders for its FebriDx Pascal and HIV Self-Test products. The company also secured a global licensing deal for a novel liver function test and expanded manufacturing capacity to support growing demand.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

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.

Atomo Diagnostics has landed a significant $502,000 order for HIV self-tests destined for an African country, underscoring sustained demand for accessible diagnostics in the region.

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.