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UpFront Diagnostics secures CE mark for LVOne rapid blood test for stroke
UpFront Diagnostics has secured CE mark approval for LVOne, a rapid blood test designed to identify large-vessel-occlusion stroke in pre-hospital settings.

nuaxia
Sep 171 min read


Proteomics International begins WA and NT rollout of PromarkerD and PromarkerEso with Healius
Proteomics International has begun the controlled commercial rollout of its PromarkerD and PromarkerEso blood tests in Western Australia and the Northern Territory through its exclusive pathology distribution agreement with Healius.

nuaxia
Sep 152 min read


Bluejay Diagnostics partners with Lovell to expand into US federal healthcare markets
Bluejay Diagnostics and Lovell Government Services have formed a distribution and co-marketing partnership to prepare Bluejay's Symphony diagnostic platform for access to US federal healthcare markets following regulatory authorisation.

nuaxia
Sep 92 min read


Renalytix and Quest Diagnostics partner to expand kidneyintelX.dkd testing across the US
Renalytix has signed a multi-year agreement with Quest Diagnostics to expand US access to its kidneyintelX.dkd blood test for patients with type 2 diabetes and chronic kidney disease.

nuaxia
Sep 21 min read


FDA clears PrecivityAD2 Alzheimer’s blood test for symptomatic adults aged 40 and older
The clearance extends FDA-authorised blood-based assessment of Alzheimer’s-associated amyloid pathology to younger symptomatic adults, providing clinicians with a less invasive alternative to PET imaging and cerebrospinal fluid testing.

nuaxia
Aug 242 min read


BioPorto advances US regulatory pathway for adult AKI test following FDA feedback
The company has expanded its US clinical validation study to support a future FDA submission for its adult NGAL kidney injury test while continuing to grow adoption of the biomarker in clinical practice.

nuaxia
Aug 212 min read


Diaceutics and Precision Cancer Consortium launch NGS concordance study for oncology biomarker testing
The collaborative initiative aims to generate evidence on the consistency of next-generation sequencing (NGS) testing across routine clinical laboratories, supporting future improvements in precision oncology diagnostics.

nuaxia
Aug 212 min read


FDA authorises Aletta as first standalone robotic blood draw device for outpatient use
The authorisation introduces the first autonomous robotic system designed to perform blood collection under phlebotomist supervision, supporting outpatient services facing workforce pressures.

nuaxia
Aug 202 min read


Health Canada licenses Light AI’s QuickScan Strep A smartphone software for suspected strep throat assessment
The Canadian authorisation moves Light AI’s AI-enabled throat-image analysis platform from investigational development into its first regulated market, providing healthcare professionals with a software-based tool to support assessment of suspected Group A Streptococcus infection.

nuaxia
Aug 142 min read


ChemoMetec and Roche Diagnostics partner to integrate cell counting and bioprocess monitoring systems
The collaboration will connect ChemoMetec’s XcytoMatic 30 cell counter with Roche’s Cedex Bio Analyzer and establish a joint go-to-market strategy for the combined bioprocess monitoring solution.

nuaxia
Aug 112 min read


NICE Recommends First Non-Invasive Endometriosis Diagnostic Tools for NHS Use
EndoSure and Ziwig Endotest will be introduced as complementary diagnostic options, aiming to reduce delays in diagnosis for millions of women affected by endometriosis.

nuaxia
Jul 93 min read
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