FDA APPROVES MEDTRONIC’S DTA SYSTEM TO TREAT PATIENTS WITH ATRIAL FIBRILLATION

Medtronic has secured approval for its DiamondTemp Ablation (DTA) system from the US Food and Drug Administration (FDA) for treating patients with atrial fibrillation.

As the first temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds, the DTA system will be used for treating patients with recurrent, symptomatic paroxysmal atrial fibrillation and those who have been unresponsive to drug therapy.

It uses radiofrequency energy and is a minimally invasive approach to create lesions (scar tissue), using heat, to interrupt irregular electrical signals in the heart.

Medtronic noted that the DTA system is an open-irrigated RF ablation system, delivering RF energy (heat) during ablations. It can also deliver real-time feedback on physical parameters, guiding the physicians as the lesion is being produced.

The DTA catheter is embedded with industrial-grade diamonds, which are 200 to 400 times higher in thermal conductivity compared to other materials used in regular RF ablation catheters.

UK OPENS NEW WALKTHROUGH COVID-19 TESTING FACILITY AT ROYAL MINT

The UK Government has opened a new walkthrough Covid-19 testing facility at the Royal Mint’s Visitor Centre Car Park to make testing more accessible to local communities.

Based at Llantrisant, Rhondda Cynon Taf, the new site is being operated in partnership with Mitie.

It will offer testing to those with Covid-19 symptoms with appointments made available each day. It will also offer self-administered tests.

The new facility is part of the largest network of diagnostic testing facilities set up in the UK that process a total of 700,000 tests each day.

The network has more than 800 sites across the country, including ten drive-through sites, 20 walkthrough sites, 22 mobile units and the Newport Lighthouse Lab in Wales.

Before setting up the new testing centre, the Royal Mint converted its visitor centre into an emergency production line in March, producing 1.9 million medical visors for the NHS.

SEQONCE LAUNCHES ASSAY FOR SARS-COV-2 N501Y VARIANT DETECTION

SeqOnce Biosciences has launched its new AzureSeq One-Step Universal RT-qPCR kit, which can be used for detecting the N501Y variant of SARS-CoV-2.

The kit uses a single-tube reaction targeting the N1 nucleocapsid gene, both alleles of S gene N501Y (A23063T) and has RNaseP as a control.

The test, which does not need viral RNA extraction, has a fast cycling protocol option, providing samples to answer results in under 30 minutes.

Furthermore, it uses common qPCR instruments with detection channels of FAM, HEX, Cy5, and ROX.

SeqOnce CSO Joe Dunham said: “The AzureSeq N501Y assay provides health officials, CLIA labs and hospitals the ability to quickly identify and monitor this important SARS-CoV-2 variant.

“We decided to also target the N1 gene so the assay can be used in front-line detection, as well as identification of samples that have previously tested positive.”

In a separate development, molecular diagnostics company Co-Diagnostics has submitted to the US FDA for an emergency use authorisation of its Covid-19 polymerase chain reaction (PCR) diagnostic saliva test.

The Logix Smart SARS-CoV-2 DS (Direct Saliva) test can identify the presence of SARS-CoV-2 in human saliva samples without needing RNA extraction of the sample.

AVACTA AND BRUKER COLLABORATE TO EVALUATE SARS-COV-2 ASSAY

Avacta Group has entered into a collaboration agreement with analytical instrumentation company Bruker to analyse the Affimer-based, bead-assisted mass spectrometry (BAMS) SARS-CoV-2 assay.

The assay has been developed by Avancta in partnership with Adeptrix.

Avacta and Adeptrix have developed a Covid-19 antigen test that merges the sample enrichment using Affimer reagents with the analytical power of mass-spectrometry.

Using a BAMS assay, a single technician can analyse up to 1,000 samples a day.

This is beyond the commonly used PCR machines’ capacity, thereby making BAMS a potentially high-throughput technique for Covid-19 screening to be used in the clinical setting.

On developing a prototype test with Adeptrix, Avacta has been working with its clinical partners in the UK to improve the assay to be incorporated into the typical workflows in a clinical microbiology lab.

Through the latest partnership with Bruker, the company will analyse the suitability of the test as a professional-use in-vitro diagnostic (IVD) product for Covid-19 to run on Bruker’s MALDI-TOF instruments for sale in the UK and Europe.

Avacta Group CEO Dr Alastair Smith said: “I am delighted to have established this collaboration agreement with Bruker to further develop the potential for the BAMS Covid-19 test as a clinical IVD."

ADVANCED MEDTECH’S COVID-19 TEST KIT RECEIVES APPROVAL IN AUSTRALIA

Temasek’s wholly owned subsidiary Advanced MedTech’s RESOLUTE 2.0 direct multiplex reverse transcription-polymerase chain reaction (RT-PCR) test kit has secured approval from Australia’s Therapeutic Goods Administration (TGA) for Covid-19.

Co-developed by Singapore’s Agency for Science Technology and Research and DSO National Laboratories, the kit has been made available for clinical use by Advanced MedTech.

Approval from TGA will enable the test kit to be used in laboratories and medical institutions across the country.

The RESOLUTE 2.0 test kit functions without the need for viral RNA extraction from patient test samples, making it one of the few such RT-PCR tests to get approval from TGA.

Advanced MedTech noted that the kit has high sensitivity and specificity towards SARS-CoV-2 despite a shortened laboratory processing time.

This can reduce potential human errors while reducing exposure of the virus to lab technicians and can deliver test results in half the time of other RT-PCR test kits.

Furthermore, the test kit can be paired with the complementary RAVE automated robotics lab system to process four times more daily throughput compared with the usual RT-PCR test.

OSTEOPORE AND MAASTRICHT UMC+ DEVELOP BONE IMPLANT SOLUTION

Singapore company Osteopore International, in partnership with Maastricht University Medical Centre (UMC+) in the Netherlands, has developed a new bone implant solution that prevents leg amputations.

The new bioresorbable 3D printed cage prevents leg amputations in severe lower leg fracture patients.

Osteopore merges biomimetic tissue science with 3D printing and materials technology to produce medical implants for meeting the requirements in both tissue and bone reconstruction and restoration.

The cage aids patients in regenerating new bone cells and was successfully designed and implanted in the first patient in the Netherlands.

Produced in Singapore and developed using Osteopore’s 3D printing and materials technology, the 3D cage is made of biodegradable material. Based on a computed tomography scan of the patient’s lower leg, it is customised to the patient.

It stimulates the growth of the patient’s new bone cells within it, eventually breaks down into water and carbon dioxide and is replaced by the patient’s own regrown bone tissue.