Latest Diagnostics News

Atomo Diagnostics has responded to ASX queries confirming it first held market-sensitive information after Lumos Diagnostics’ FDA CLIA waiver approval for FebriDx. The company defended its trading halt and capital raise timing, asserting full compliance with ASX Listing Rules.

Proteomics International Laboratories has slashed a quarter of its workforce and appointed a new CFO amid a strategic pivot to commercial diagnostics, aiming to save over $1 million annually and sharpen execution.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.

Radiopharm Theranostics has finished enrolling patients in its U.S. Phase 2b trial of RAD 101 for brain metastases imaging, reporting promising interim data showing 90% concordance with MRI. The company aims to launch a pivotal Phase 3 trial following a full data readout in June 2026.

Genetic Signatures has locked in a 10-year supply deal with Denmark’s Hvidovre Hospital for its EasyScreen™ Pan-Enteric assay, marking a significant step in its European expansion. The agreement covers 28,000 tests in the first year with growth expected, leveraging the company’s proprietary 3base® technology to streamline complex gastrointestinal pathogen detection.

Telix Pharmaceuticals has initiated a US$550 million convertible bonds offering to refinance existing 2029 bonds and support general corporate purposes, securing low-cost, non-dilutive financing with a conversion premium above current share price.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Telix Pharmaceuticals and Regeneron have entered a strategic collaboration to co-develop next-generation radiopharmaceutical therapies, with Telix receiving a $40 million upfront payment and potential milestones exceeding $2 billion.

Lumos Diagnostics Holdings Limited (ASX: LDX) has opened a Share Purchase Plan (SPP) offering eligible shareholders the chance to invest up to A$30,000 at A$0.225 per share, accompanied by free options. The SPP aims to raise up to A$2 million and closes on 24 April 2026.

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Pacific Edge reported a 2.7% increase in test volumes for Q4 2026 despite operational challenges, supported by growing momentum toward Medicare coverage and expanded commercial payer adoption in the US and Asia Pacific.

Lumos Diagnostics has entered a three-year contract manufacturing agreement with Micro-Pak to produce the Mold Analyzer system, marking a transition from development to commercial-scale manufacturing with an initial US$250,000 purchase order.