Diagnostics

Diagnostics

Medicus Pharma clears FDA review for SkinJect Gorlin Syndrome trial

The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
The NASDAQ-listed biotech received a "Study May Proceed" letter for its Phase 2b NDA-enabling study of SkinJect in patients with Gorlin Syndrome.
Diagnostics
Regulatory Science
Biologics

OraSure wins FDA EUA for second-generation OraQuick Ebola 2.0 test

OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
OraSure's updated rapid antigen test detects all four disease-causing Ebola viruses and was developed with BARDA funding amid a live DRC outbreak.
Diagnostics

Alpha Tau treats first immunocompromised cSCC patient in ADMIRE trial

Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Alpha Tau's ADMIRE study has dosed its first patient, targeting a population for whom standard checkpoint immunotherapy carries significant organ-rejection risk.
Diagnostics
Biologics

IGeneX single-step immunoblot nearly doubles early Lyme detection rate

A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
A peer-reviewed study found IGeneX's FDA-cleared IB tests detected early Lyme disease in 58.3% of cases versus 30.0% with standard
Digital Health
Diagnostics

RWS launches integrated eCOA linguistic validation service

RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
RWS has combined COA licensing, translation, linguistic validation and rater training under one programme team to cut delays in global clinical trials.
Diagnostics
Digital Health

Brain & Performance Centre signs MOU with UAE Athletic Commission

The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
The DP World-owned brain health facility will offer optional neurological assessments to professional boxers competing in sanctioned UAE events.
Diagnostics

Aligos Therapeutics completes enrolment in Phase 2 HBV study

Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
Aligos has fully enrolled 245 participants in B-SUPREME, its Phase 2 trial of pevifoscorvir sodium in chronic hepatitis B, with topline data expected in
Diagnostics
Biologics

Roche wins CE Mark for automated blood test for latent TB

The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
The Elecsys IGRA TB test processes samples in 19 minutes, cutting standard IGRA turnaround in half and integrating with Roche's existing cobas immunoassay platforms.
Diagnostics

Tarsus Pharmaceuticals acquires iRenix Medical for up to $565m

Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
Tarsus is acquiring iRenix and its IRX-101 ocular antiseptic, backed by Phase 2b/3 data showing significant pain and corneal toxicity reductions.
Diagnostics

Endogenex completes 350-patient enrolment in ReCET diabetes device trial

Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
Endogenex has fully enrolled its sham-controlled ReCET study of a duodenal pulsed electric field device for type 2 diabetes across 40 sites.
Diagnostics
Genomics

DiamiR and AlzLabs join forces on Alzheimer's biomarker study

DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
DiamiR Biosciences and AlzLabs will combine protein and microRNA blood biomarkers to improve early detection of Alzheimer's disease.
Diagnostics
Biotech

Urteste wins USPTO patent for urine-based Panuri pancreatic cancer test

The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
The Polish diagnostics company secured US patent protection for its non-invasive Panuri test as a European clinical trial enrols its first participants.
Diagnostics

Vilnius University physicists patent pea-sized triplex radiation sensor

A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
A three-layer sensor developed at Vilnius University can detect, identify and locate radiation sources in real time, from lab doses to megagray nuclear emergency
Diagnostics
Genomics

Myriad Genetics Prolaris meta-analysis backs prostate cancer staging

A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
A pooled analysis of 8,478 patients shows Myriad's Prolaris Biopsy Test adds prognostic value beyond standard clinical risk tools in localised prostate cancer.
Diagnostics

IBA wins contract to install Portugal's first proton therapy centre

Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.
Belgian particle accelerator firm IBA will supply two Proteus ONE compact systems to IPO-Porto, establishing the country's first proton therapy facility by 2029.
Biologics
Diagnostics

Telix wins FDA alignment to open ProstACT Global Phase 3 in US

Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Telix Pharmaceuticals secured FDA agreement on protocol and statistics for Part 2 of its lutetium-177 rosopatamab Phase 3 trial in metastatic prostate cancer.
Proteomics
Diagnostics

Seer wins EPO patent ruling and secures ITC probe into Nanomics

Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Seer has defended a key European proteomics patent and launched a US trade investigation targeting Nanomics' competing Proteonano products.
Diagnostics
Genomics
Regulatory Science

Mdxhealth GPS-ProMPT study published in European Urology Oncology

The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
The peer-reviewed Oxford study of 409 men over six years underpins the GPS-ProtecT randomised controlled trial of mdxhealth's 17-gene prostate assay.
Digital Health
Diagnostics

Firstsource and AppliedAI report 95% cuts in live AI deployments

Six months after a strategic equity deal, the partners say live deployments cut healthcare processing times by 93% and lifted admissions throughput up to tenfold.
Six months after a strategic equity deal, the partners say live deployments cut healthcare processing times by 93% and lifted admissions throughput up to tenfold.
Diagnostics
Genomics

A3P Biomedical's Stockholm3 outperforms PSA in 12,670-man study

Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
Stockholm3 detected 90% of aggressive prostate cancers versus 52% for standard PSA testing in a large population-based screening trial published in Annals of Internal
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