Genomics

Genomics

Inside the UK's £650m bet on genomic medicine

With Genomics England's newborn screening trial now enrolling, the Department of Health has made its most explicit commitment yet to whole-genome sequencing as frontline NHS infrastructure.

The UK government has quietly positioned itself at the front of a race few of its peers are even running.

Mark Walker  · 
Diagnostics
Genomics

Freenome's updated SimpleScreen CRC test improves APL sensitivity

Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
Validation data show the next-generation blood test lifted advanced precancerous lesion sensitivity to 18.2%, the highest reported for any non-invasive CRC screening
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio encaleret hits ADH1 endpoints as NDA earns Priority Review

Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
Phase 3 CALIBRATE data show encaleret improved symptoms in all treated participants, with the FDA setting a May 2027 PDUFA date for the NDA.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

Cerenome wins Florida Blue coverage for CNSide CSF molecular tests

The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
The payer agreement adds six million covered lives and is the first to include CNSide's new DNA and RNA molecular profiling tests alongside tumour
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

Life Biosciences reports Phase 1 ER-100 data in glaucoma

First-in-human interim data show ER-100 was well-tolerated at Dose Level 1 in three open-angle glaucoma participants, with visual field signals
First-in-human interim data show ER-100 was well-tolerated at Dose Level 1 in three open-angle glaucoma participants, with visual field signals
The Biotech Times Editorial Team  · 
Diagnostics
Genomics
Biologics

Myriad Genetics and SOPHiA GENETICS team up on prostate HRD biomarker

The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The two NASDAQ-listed companies will co-develop a decentralised companion diagnostic for prostate cancer genomic instability scoring, with AstraZeneca involved.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics
Pharmaceuticals
Biologics

Editas Medicine clears first hurdle for EDIT-401 hyperlipidaemia trial

Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
Editas has received ethics and regulatory approval in Australia to begin its Phase 1/2 Strive trial of in vivo gene editor EDIT-401 in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics
Bioprocessing

UAE biopharma push targets double-digit precision medicine growth

A Frost & Sullivan report for World Health Expo projects over 10% annual precision medicine growth in the Middle East over the next five to seven
A Frost & Sullivan report for World Health Expo projects over 10% annual precision medicine growth in the Middle East over the next five to seven
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

BridgeBio to present CALIBRATE Phase 3 encaleret data at ASBMR 2026

BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
BridgeBio will share 24-week Phase 3 CALIBRATE trial data on encaleret in ADH1, covering bone turnover and patient-reported outcomes, at ASBMR in Boston.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

AAVantgarde sees early efficacy signals in dual-AAV eye therapy

AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
AAVantgarde Bio presented Phase 1/2 data showing visual function gains in Usher syndrome and strong preclinical support for its Stargardt programme at EURetina 2026.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Cullinan files NDA for zipalertinib in first-line EGFR ex20ins NSCLC

Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
Cullinan Therapeutics has begun an FDA RTOR submission for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC, backed by Phase 3 data.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biologics
Genomics

Atsena's ATSN-201 shows durable XLRS benefit at 18 months

Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
Atsena Therapeutics reported sustained structural and functional gains in seven of nine treated eyes, with a BLA filing now targeted for late 2028.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

uniQure AMT-130 shows 80% disease slowing at 36 months in HD trial

Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
Updated Phase I/II data on ifezuntirgene inilparvovec show an 80% slowing of Huntington's disease progression at 36 months across 15 high-dose patients.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics
Regulatory Science

Oryzon secures EMA approval to start HOPE-2 vafidemstat trial in PMS

Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
Oryzon Genomics has received EMA authorisation to begin a Phase IIa study of vafidemstat in Phelan-McDermid Syndrome, a rare autism-linked genetic disorder with
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Belite Bio to present DRAGON Phase 3 tinlarebant data at Euretina

Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
Belite Bio will present topline Phase 3 results for tinlarebant in adolescent Stargardt disease at Euretina in Vienna, ahead of a February 2027 FDA PDUFA
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Genomics

Prime Medicine wins FDA IND clearance for PM647 in AATD

The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in
The Cambridge biotech's in vivo Prime Editor targets the root genetic cause of alpha-1 antitrypsin deficiency, with first-in-human data expected in
The Biotech Times Editorial Team  · 
Pharmaceuticals
Genomics

Telomir Pharmaceuticals publishes preclinical AMD data for Telomir-Zn

A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
A peer-reviewed zebrafish study shows Telomir-Zn restored visual function and retinal structure, extending the drug's biology beyond its lead oncology programme.
The Biotech Times Editorial Team  · 
Biologics
Cell & Gene Therapy
Diagnostics
Genomics

NCCN guidelines name clonoSEQ for myeloma MRD testing

Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
Updated NCCN multiple myeloma guidelines establish a dedicated MRD framework and specifically name Adaptive Biotechnologies' clonoSEQ as an FDA-cleared assay.
The Biotech Times Editorial Team  · 
Genomics
Diagnostics

Bionano OGM detects hidden genomic risk in MDS and AML studies

Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
Three peer-reviewed studies across the US, Finland, and Spain show optical genome mapping uncovers clinically actionable variants missed by standard karyotyping.
The Biotech Times Editorial Team  · 
Diagnostics
Genomics

Veracyte acquires Convergent Genomics for up to $180m

Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
Veracyte is adding the UroAmp urinary tumour DNA platform to its bladder cancer portfolio, with commercialisation targeted for late 2028.
The Biotech Times Editorial Team  · 
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