Diagnostics

Diagnostics
Digital Health
Genomics

Nano Dimension signs term sheet to merge with Infinite Epigenetics

Nano Dimension is pivoting from digital manufacturing into epigenetic diagnostics via a proposed $890m combination with AI-powered Infinite Epigenetics.
Nano Dimension is pivoting from digital manufacturing into epigenetic diagnostics via a proposed $890m combination with AI-powered Infinite Epigenetics.
Diagnostics

Eliaz Therapeutics opens Reg CF round to fund sepsis apheresis device

The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.
The California biotech is crowdfunding to advance XGal-3, an FDA Breakthrough Device-designated apheresis system targeting Galectin-3 in sepsis.
Diagnostics

Intrommune reports exploratory peanut tolerance data for OMIT

Intrommune Therapeutics presented Phase 1 exploratory data showing all INT301-treated adults tolerated peanut protein at 50 times their baseline dose.
Intrommune Therapeutics presented Phase 1 exploratory data showing all INT301-treated adults tolerated peanut protein at 50 times their baseline dose.
Diagnostics

Upstream Bio verekitug met NPS target in 79% of VIBRANT patients

Post-hoc responder analyses from the Phase 2 VIBRANT trial show verekitug achieved clinically meaningful nasal polyp improvements in roughly four in five treated
Post-hoc responder analyses from the Phase 2 VIBRANT trial show verekitug achieved clinically meaningful nasal polyp improvements in roughly four in five treated
Diagnostics

Vivoryon touts DKD kidney data as it hunts Phase 2b partner

The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
The Dutch biotech reported compelling eGFR data in diabetic kidney disease patients and confirmed cash runway only into Q4 2026 as partnership talks continue.
Diagnostics
Genomics

IMDX GraftAssure CM-Score lifts kidney rejection PPV to 81%

Insight Molecular Diagnostics says its combination model score outperforms single-metric dd-cfDNA in a peer-reviewed study of 414 kidney transplant patients.
Insight Molecular Diagnostics says its combination model score outperforms single-metric dd-cfDNA in a peer-reviewed study of 414 kidney transplant patients.
Diagnostics

Roche gains FDA nod for first PTEN companion diagnostic

The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
The VENTANA PTEN (SP218) RxDx Assay is the first IHC test approved to identify PTEN-deficient prostate cancer patients eligible for capivasertib.
Diagnostics

Syndax revumenib shows broad activity across leukaemia studies at EHA

Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
Five datasets presented at EHA 2026 show revumenib achieving high remission and MRD-negativity rates across multiple acute leukaemia subtypes and treatment settings.
Diagnostics

Caribou Biosciences CB-011 shows 83% CR rate in r/r myeloma at EHA

Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
Updated CaMMouflage phase 1 data show deep, durable responses from a single dose in heavily pretreated, BCMA-naïve multiple myeloma patients.
Diagnostics

Roche's Tecentriq wins FDA Priority Review in stage III colon cancer

The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
The FDA accepted Roche's sBLA for Tecentriq plus chemotherapy in dMMR/MSI-H stage III colon cancer, with a decision expected by 9 October
Diagnostics

Kura and Kyowa Kirin report 94% 12-month survival in AML combo trial

KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
KOMET-007 Phase 1/2 data show ziftomenib plus 7+3 chemotherapy delivered high remission rates and durable responses in newly diagnosed NPM1-mutant AML.
Diagnostics
Genomics

OraSure wins FDA clearance for at-home STI urine collection kit

OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
OraSure's Colli-Pee Dx kit, cleared for use with Roche cobas systems, enables self-collected urine testing for four STIs from home.
Bioprocessing
Diagnostics

RadioMedix wins FDA approval for generic Ga-68 PSMA-11 PET agent

RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.
Diagnostics
Digital Health

Ceribell Clarity AI links seizure burden to neurological outcomes

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death
Diagnostics

DBV Technologies presents VITESSE subgroup data at EAACI 2026

New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
New VITESSE subgroup analysis shows VIASKIN Peanut Patch hit significance across asthma, food allergy and atopic dermatitis co-morbidities in children.
Diagnostics

Sequel Med Tech twiist AID System cuts HbA1c in type 2 pivotal trial

A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
A 307-patient pivotal trial showed twiist reduced HbA1c by 0.7 points and raised time in range by 16 percentage points over 13 weeks.
Diagnostics

Sparrow Pharma Phase 2a data back clofutriben in Type 2 diabetes

Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Sparrow Pharmaceuticals reported statistically significant HbA1c and cholesterol reductions from a placebo-controlled trial, with larger benefits in cortisol-enriched
Diagnostics

Boehringer's survodutide hits Phase III endpoints in obesity and MASLD

Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Full results from SYNCHRONIZE-1 and SYNCHRONIZE-MASLD, published in NEJM and Nature Medicine, show targeted visceral and liver fat reduction alongside meaningful weight
Diagnostics

Diasome Phase 2b data shows HDV-insulin cuts hypoglycemia in T1D

OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
OPTI-2 trial data show HDV-LIS matched glycaemic control while significantly reducing hypoglycaemic events versus standard insulin lispro in 226 adults.
Diagnostics

Biomea Fusion presents icovamenib diabetes data at ADA 2026

Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
Phase II findings show durable HbA1c reductions and beta cell preservation in both type 1 and type 2 diabetes, with no immune activation signals.
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