Search Results for “diagnostic” – Page 46 – media

Oxford Biodynamics launches prostate screening test

EpiSwitch is designed for men with prostate cancer risk in the UK and is 94% accurate Oxford BioDynamics – a company developing precision medicine tests – has announced that its EpiSwitch Prostate Screening (PSE) blood test will be available to UK patients. The existing PSA test is 55% accurate, and is considered an unreliable test by many doctors, including those in the NHS. The new PSE test has been designed to run alongside the standard PSA test, and combines the PSA score with five proprietary epigenetic biomarkers to predict – with 94% accuracy – the presence (or absence) of prostate cancer. The PSE test has emerged after nearly a decade’s long collaboration between OBD, Imperial College London, University of East Anglia, Imperial College NHS Trust and leading prostate cancer experts across the UK. The development was also part of the wider PROSTAGRAM screening pilot. Mathias Winkler, Consultant Urologist and Surgeon ...
- Source: drugdu
- 118
- September 29, 2023
CMS leader defends breakthrough device reimbursement proposal at House hearing

Dive Brief An acting director at the Centers for Medicare and Medicaid Services has defended contentious aspects of the planned breakthrough reimbursement pathway. At a hearing that lasted almost three hours, CMS’ Dora Hughes made the case for restricting the Transitional Coverage for Emerging Technologies (TCET) pathway to five reviews a year and discussed the exclusion of in vitro diagnostics from the program. Hughes is the agency’s acting chief medical officer and the acting director at its center for clinical standards and quality. Some lawmakers, while voicing support for TCET, joined medtech trade groups in calling for the CMS to expand the scope of the pathway to cover diagnostics before the plan is finalized. Dive Insight Hughes spent Tuesday morning at a House health subcommittee hearing fielding questions about how to improve seniors’ access to innovative drugs, medical devices and technology. TCET, a pathway that the CMS proposed for consultation ...
- Source: drugdu
- 100
- September 22, 2023
BeiGene and Nona Biosciences expand collaboration for antibody discovery

BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement BeiGene and Nona Biosciences have announced an agreement to expand their strategic collaboration for antibody discovery. The collaboration will allow BeiGene to utilise Nona’s Harbour Mice platform – a fully human transgenic mouse platform – to further improve therapeutic antibody discovery efficiency and flexibility. BeiGene first obtained the rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programmes in 2018 as part of the now expanded collaboration. Harbour Mice works to generate fully human monoclonal antibodies in classical two light and two heavy chain (H2L) formats and heavy chain only (HCAb) formats. The H2L platform allows mice to bear fully human immunoglobulin genes with robust B cell development and antibody maturation. The HCAb platform is the world’s first human HCAb transgenic mouse platform that works to generate fully human heavy chain-only antibodies. It allows the ...
- Source: drugdu
- 207
- September 21, 2023
Meridian Bioscience announces FDA clearance for innovative Curian® Shiga Toxin Assay

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the United States Food and Drug Administration (FDA) had granted clearance for the company’s new Curian® Shiga Toxin assay. This assay joins Curian HpSA® and Curian Campy as Meridian expands its Curian diagnostic platform to maintain leadership in the gastrointestinal disease testing market. Foodborne illness is a severe global public health problem that causes 48 million people to get sick yearly and 128,000 hospitalizations from common bacterial agents like Campylobacter and E. coli.1 Meridian is expanding its foodborne immunofluorescent testing capabilities beyond Campylobacter by adding Shiga toxin to the Curian platform. Speedy diagnosis is essential with patients suspected of having a Shiga toxin-producing E. coli infection because the use of antibiotics for treatment can increase Shiga toxin release, leading to hemolytic uremic syndrome (HUS), a potentially life-threatening complication. The Curian Shiga ...
- Source: drugdu
- 241
- September 20, 2023
GE HealthCare partners with Mayo Clinic to accelerate work on imaging and AI

Dive Brief GE HealthCare has teamed with Mayo Clinic to advance medical imaging, artificial intelligence and theranostics, a type of cancer treatment that involves imaging and targeted therapeutics. The organizations will collaborate on the application of AI to magnetic resonance imaging, the automation of diagnostic and interventional ultrasound and other activities that could improve patient care. GE HealthCare has formed a series of partnerships since separating from its parent company, striking deals with companies including Boston Scientific, Johnson & Johnson and Medtronic. Dive Insight GE HealthCare and other parts of its former parent company, GE, have a long history of working with Rochester, Minnesota-based Mayo, teaming up with the hospital to test remote monitoring devices, found a gene therapy software startup and develop a medical electronic record system. The latest deal brings together scientists, technology developers and clinicians working at GE HealthCare and Mayo to collaborate on four core areas ...
- Source: drugdu
- 128
- September 18, 2023
New Biotech Targets Rare Respiratory Disorders with Inhaled Gene Therapies

By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
- Source: drugdu
- 108
- September 18, 2023
Illumina Taps Agilent Exec as New CEO Amid Company’s Daunting Challenges

By Kate Goodwin Pictured: Illumina sign in San Diego/iStock, Georgejason After months of upheaval, Illumina named Jacob Thaysen its new CEO Tuesday, replacing Francis deSouza who stepped down in June after losing a proxy fight with billionaire activist investor Carl Icahn. Thaysen, the former senior vice president of Agilent Technologies and president of its life sciences and applied markets group, will take the reins Sept. 25. He has his work cut out for him. The DNA-sequencing technology company has faced a rocky road since its acquisition agreement with cancer diagnostics maker GRAIL in September 2020. The deal faced scrutiny from both the Federal Trade Commission and the European Commission due to concerns over antitrust laws. In April, activist investor Carl Icahn went after then-CEO Francis deSouza and campaigned to replace three of Illumina’s board members. While his efforts only got him one seat on the board, deSouza did step down ...
- Source: drugdu
- 103
- September 7, 2023
New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease

By Claire Jarvis Pictured: Close-up of an arm receiving a blood draw/iStock, montiannoowong Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating. With Leqembi’s full approval, the Centers for Medicare and Medicaid Services (CMS) has instituted broader coverage of the drug—with stipulations. To ensure reimbursement, physicians must participate in a qualified registry and patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia with evidence of beta-amyloid deposits. To help facilitate this, CMS proposed in July 2023 to increase its coverage of PET scans to detect these amyloid plaques—however, cheaper and faster diagnostic methods are still being developed. The past ...
- Source: drugdu
- 190
- September 6, 2023
Trade groups urge CMS to expand, quickly finalize breakthrough device pathway

Dive Brief Medtech trade groups have voiced support for the Centers for Medicare and Medicaid Services’ plan to accelerate reimbursement of certain breakthrough devices. In letters sent on the same day, AdvaMed and the Medical Device Manufacturers Association (MDMA) urged CMS to quickly finalize the program, while also naming changes they want the centers to make. The trade groups recommended changes including the expansion of the CMS program to cover breakthrough diagnostics, products authorized in the previous three years and medical devices that are nearing approval. Dive Insight In June, CMS released a draft version of the Transitional Coverage for Emerging Technologies (TCET) pathway for consultation. The path could fill a gap created by the repeal of the contentious Medicare Coverage for Innovative Medical Technologies plan and address industry calls to cut the gap between device approval and reimbursement. AdvaMed and MDMA submitted feedback on the new proposal to CMS ...
- Source: drugdu
- 153
- September 1, 2023
VC funding in medtech ticks up, raising hopes that slump has bottomed

Dive Brief Venture capital investment in medtech startups increased sequentially in the second quarter, in both volume and value, according to the financial database PitchBook. Activity remains down from last year, and well down from the highs hit in 2021, but the PitchBook analysts think funding bottomed out in the first quarter and will “inch upwards over the rest of the year.” The analysts also speculated that M&A activity could pick up now that large companies “have worked through their numerous spinoff and spinout plans.” On Wednesday, wound care device maker Sanuwave Health announced it plans to go public through a $127.5 million merger agreement with SEP Acquisition, a special purpose acquisition company, or SPAC. Dive Insight VC investment in medtech fell across 2022, and the downward trend in deal value continued in the first quarter of 2023. The second quarter brought potential signs that a recovery is starting. Deal ...
- Source: drugdu
- 99
- August 28, 2023

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