ALTHEA INTRODUCES AFFORDABLE COVID-19 ANTIGEN TESTS

01 february | covid-19

Medical technology services provider Althea UK and Ireland has launched high-quality and cost-effective SARS-CoV-2 rapid antigen tests.

Manufactured by Roche, the antibody test can help identify SARS-CoV-2 infection in suspected people and can deliver results in 15 minutes.

It is a rapid chromatographic immunoassay, which uses nasopharyngeal swab samples for testing and has a sensitivity of 96.52% and specificity of 99.68%.

In addition, the test can be used for symptomatic and asymptomatic individuals.

The company noted that the latest service, which is accessible for pharmacies, dentists, hospitals, clinics and hospital support companies whose staff access clinical settings, will offer a valuable initial screening test for staff who are possibly exposed to Covid-19 or work in high-risk settings.

Althea CEO David Rolfe said: “As Covid-19 continues to spread and while vaccinations are being rolled out, testing remains crucial to contain the spread of Covid-19.

“We are pleased to be able to offer the Roche rapid antigen tests to support those providing vital services across the country with a reliable, high-quality testing option at an affordable price.

“At a time where budgets are stretched and health services are under pressure, as a trusted partner to many hospitals in the UK, we want to do our part in supporting those working on the frontline.”

The company manages and maintains medical technology in hospitals and is entirely vendor-independent, meaning they can combine the best technology from across all manufacturers.

Althea noted that during Covid-19, it performed a major role in setting up equipment at the London NHS Nightingale Hospital, which was established to provide emergency care to Covid-19 patients.

Currently, the company offers rapid Covid-19 tests to help further support the national response to the pandemic.

01 february | Approvals

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.

01 february | covid-19

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.

29 january | manufacturing

MICROGEM ACQUIRES JUMP START TO EXPAND COVID-19 SALIVA TEST PRODUCTION

Molecular diagnostics company MicroGEM has acquired engineering company Jump Start Manufacturing to expand its Spitfire 6830 SARS-CoV-2 testing system production.

Spitfire is a PCR-based point-of-need saliva test.

The company expects that with its pilot-scale manufacturing facility in Charlottesville, along with its newly established large-scale production facilities in Ogden, Utah, and Hudson, New Hampshire, it can expand its manufacturing in the US.

It plans to create more than 500 jobs between the two locations.

Together, the facilities have more than 120,000ft² of combined space and will enable MicroGEM to produce 160,000 test kits every day.

MicroGEM CEO Jeff Chapman said: “We are proud to join forces with the talented Jump Start team to accelerate the production and deployment of our innovative Spitfire6830 SARS-CoV-2 testing system.

“Bringing Jump Start’s leading manufacturing capabilities and expertise under the MicroGEM umbrella and dramatically expanding our production capabilities will ensure that more Americans have greater access to high-quality Covid-19 tests, bringing key tools to help end this devastating pandemic.”

29 january | testing

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.

29 january | testing

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."

In brief

SWIFT BIOSCIENCES INTRODUCES GENE PANEL TO DETECT NEW SARS-COV-2 STRAINS

US company Swift Biosciences has launched Swift Normalase Amplicon SARS-CoV-2 S Gene Panel in an effort to accelerate the surveillance of new SARS-COV-2 strains. The new targeted gene panel covers 100% of the SARS-CoV-2 S gene, even with limited viral titers, and eradicates the need to carry out qPCR for library normalisation.

ABBOTT’S COVID-19 ANTIGEN TEST DEVICE RECEIVES CE MARK

Abbott has received CE Mark for its Panbio Covid-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing. The lateral flow assay uses nasal or nasopharyngeal swab for collecting specimens from people.

GENTEGRA TO STUDY NEW SALIVA SAMPLE COLLECTION DEVICES FOR COVID-19

US-based company GenTegra has announced a study on the development and characterisation of two novel Covid-19 saliva sample collection tube devices.


GenTegra Saliva Transport Medium (GTR-STM) and direct-into-PCR GenTegra GTR-STMdk are devices that eradicate the dilution of virus levels in saliva samples, without compromising on safety and convenience while transporting saliva samples at ambient conditions.

PERKINELMER LAUNCHES ASSAY KITS TO ADVANCE GPCR THERAPEUTICS DISCOVERY

PerkinElmer has announced the launch of new G Protein-Coupled Receptor TR-FRET Binding Assay and Beta-Arrestin kits to help advance therapeutic discovery.

AKTIIA RECEIVES CE MARK FOR 24/7 BLOOD PRESSURE MONITORING SYSTEM

Aktiia has received a CE mark for its automated blood pressure monitoring system, which the company says is the first of its kind. The Class IIa medical device is designed to gather blood pressure data 24/7, both during the day and while the wearer sleeps.

28 january | approvals

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.

28 january | device development

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.

In brief

SWIFT BIOSCIENCES INTRODUCES GENE PANEL TO DETECT NEW SARS-COV-2 STRAINS

US company Swift Biosciences has launched Swift Normalase Amplicon SARS-CoV-2 S Gene Panel in an effort to accelerate the surveillance of new SARS-COV-2 strains. The new targeted gene panel covers 100% of the SARS-CoV-2 S gene, even with limited viral titers, and eradicates the need to carry out qPCR for library normalisation.

ABBOTT’S COVID-19 ANTIGEN TEST DEVICE RECEIVES CE MARK

Abbott has received CE Mark for its Panbio Covid-19 Ag Rapid Test Device to detect SARS-CoV-2 virus for two new uses of asymptomatic testing and self-swabbing. The lateral flow assay uses nasal or nasopharyngeal swab for collecting specimens from people.

GENTEGRA TO STUDY NEW SALIVA SAMPLE COLLECTION DEVICES FOR COVID-19

US-based company GenTegra has announced a study on the development and characterisation of two novel Covid-19 saliva sample collection tube devices.


GenTegra Saliva Transport Medium (GTR-STM) and direct-into-PCR GenTegra GTR-STMdk are devices that eradicate the dilution of virus levels in saliva samples, without compromising on safety and convenience while transporting saliva samples at ambient conditions.

PERKINELMER LAUNCHES ASSAY KITS TO ADVANCE GPCR THERAPEUTICS DISCOVERY

PerkinElmer has announced the launch of new G Protein-Coupled Receptor TR-FRET Binding Assay and Beta-Arrestin kits to help advance therapeutic discovery.

AKTIIA RECEIVES CE MARK FOR 24/7 BLOOD PRESSURE MONITORING SYSTEM

Aktiia has received a CE mark for its automated blood pressure monitoring system, which the company says is the first of its kind. The Class IIa medical device is designed to gather blood pressure data 24/7, both during the day and while the wearer sleeps.