industry news

07 APRIL 2020

BGI and AID Genomics partner to build Covid-19 testing lab in GazA

China’s genome sequencing company BGI has partnered with Israeli medical technology company AID Genomics to build an emergency testing laboratory in Gaza for coronavirus (Covid-19).

Both companies have secured approval from Israeli and Palestinian authorities for the lab, which will test 3,000 Gaza residents for Covid-19 every day.

AID Genomics plans to initiate localised fundraising for the lab and will also provide necessary equipment and personnel.

The fundraising will be lead by AID Genomics’ parent company AID Group and China-based non-profit organisation Mammoth Foundation.

AID Genomics CEO Snir Zano said: “In the past months, we have been working with BGI at full speed to assist as much as we can. To my delight as an Israeli, our proposal was approved by the Palestinian Authorities and other relevant departments.

“We are fortunate that Mammoth Foundation and our chairman’s, Kelvin Wu’s philanthropic family arm, i-Future Foundation, are the first to lead the donation. The lab will be a HuoYan Lab Solution and be ready to perform up to 3,000 tests per day.”

BGI built the first HuoYan Laboratory in Wuhan in five days in February, following the Covid-19 outbreak.

The company has also set up four additional labs in other major cities. It has performed more than 500,000 coronavirus tests in China so far.

AID Group has been supplying BGI-developed test kits in Israel. Both companies have previously collaborated on cancer genomics for two years.

BGI’s immense testing capability has enabled a fast reaction time and rapid treatment for Covid-19 patients.

07 APRIL 2020

Co-Diagnostics receives emergency use authorisation for Covid-19 test

Co-Diagnostics has obtained emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Logix Smart Coronavirus Covid-19 Test.

Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can now use the test to detect the presence of SARS-CoV-2, the virus, which causes Covid-19.

Using the company’s CoPrimer technology, the test will target the RdRp gene of the SARS-CoV-2 virus. It is run on a real-time RT-PCR kit that targets conserved regions in the virus genome.

Co-Diagnostics CEO Dwight Egan said: “We believe that this authorisation confirms the quality and performance of our Covid-19 test and that it is a significant step in opening more doors and helping this test to reach an even wider audience.

“Many experts agree that accessibility of widespread testing is an important element to ‘flattening the curve’ as US cases of Covid-19 continue to rise and that increased testing throughput is vital to achieving this objective.”

Following FDA’s policy for diagnostic tests for coronavirus during the current public health emergency, Co-Diagnostics began distributing the test to some US CLIA labs last month.

Earlier, the company started sales of its CE-IVD test to the European Community and to other global markets that accept a CE Mark as valid regulatory approval.

In February, Logix Smart Coronavirus COVID-19 Test secured CE Mark approval.

Additionally, Co-Diagnostics launched a research-use-only (RUO) CoPrimer test for coronavirus (2019-nCoV) during the same month. The test helps to detect the most optimal target on the 2019-nCoV genome for a PCR assay.

06 APRIL 2020

MG Motor in talks with medical device makers to produce ventilators

06 APRIL 2020

Leica receives FDA emergency use clearance to diagnose Covid-19

Leica Biosystems has received the US Food and Drug Administration (FDA) clearance for its Aperio ImageScope DX Viewer for remote diagnosis of coronavirus (Covid-19) under emergency use.

The software enables pathologists to safely view images acquired through Aperio AT2 DX Scanner and diagnose cases from remote locations.

Leica Biosystems senior medical director Keith Wharton said: “In this time of critical need due to the Covid-19 pandemic, the Aperio AT2 DX system, including remote use of the Aperio ImageScope DX viewer, will allow pathologists to maintain a high standard of care, but now from remote locations using a digital pathology workflow.”

Commenting on the new development, Leica Biosystems president Melissa Aquino said: “This remote use capability will be transformative and help alleviate the pressure that the emergence of the Covid-19 outbreak has put on healthcare facilities.”

Based in Germany, the company has branches in approximately 100 countries across the world. It specialises in workflow solutions and automation.

Meanwhile, the world is witnessing a rise in coronavirus cases. According to the latest reports, the number of confirmed cases has crossed one million with 69,498 deaths.

In the US, 337, 637coronavirus cases have been reported, while the death toll has reached 9,647.

To meet the ongoing demand for Covid-19 testing, US FDA recently relaxed its regulations around Covid-19 diagnosis.

Currently, the tests developed and used by laboratories across the country can be authorised by state Departments of Health without direct engagement from the FDA.

In addition, the developers are not required to pursue an emergency use authorisation (EUA) with the FDA to have their assays approved.

03 APRIL 2020

Cassia Networks and VivaLNK partner to help China fight Covid-19

Cassia Networks and VivaLNK have partnered to help China fight the coronavirus (Covid-19) by lending their technologies to the Shanghai Public Health Clinical Center (SPHCC).

As part of the partnership, SPHCC is currently using Cassia’s gateways and VivaLNK’s medical wearable sensors.

The spread of the pandemic within the clinical centre, especially cross-infection from patient-to-patient and patient-to-caregiver, remains a key problem.

The integration of Cassia’s gateways and IoT Access Controller with VivaLNK’s body temperature sensors is aimed at solving the issue by reducing the contact between patient and medical staff and the contact amongst the patients.

Cassia Networks CEO Felix Zhao said: “Cassia is excited to be working with VivaLNK to help fight the spread of infectious diseases such as Covid-19, as well as helping save lives.

“With the combination of VivaLNK’s continuous health monitoring solutions, Cassia’s Bluetooth gateways and IoT Access Controller, we can better equip clinical centres and medical staff worldwide with the critical tools they need to address this and future pandemics.”

VivaLNK’s body temperature sensors supply constant, real-time monitoring of any changes in body temperature.

Cassia’s gateways gather the data and wirelessly transmit it to a nurse’s station for continuous monitoring through IoT Access Controller.

It enables medical staff to provide a holistic view of their vitals in real-time.

40 Bluetooth Low Energy devices can be paired and connected simultaneously with Cassia’s gateway.

VivaLNK CEO Jiang Li said: “The concept of remote patient monitoring using wireless medical wearables can extend into a clinical environment where there is a need to minimise patient contact and for a more flexible deployment model.

“The combination of VivaLNK sensors and Cassia’s gateways enables medical centres to rapidly deploy patient monitoring solutions not only in China but worldwide.”

Deployment of additional systems in other medical centres is expected to take place in the coming days.

Meanwhile, both companies are also working to enable future integration, using VivaLNK’s Multi-Vital ECG Sensor and Cassia’s gateways.

02 APRIL 2020

Sectra receives FDA clearance for digital pathology solution

Medical imaging IT and cybersecurity company Sectra has received US Food and Drug Administration’s (FDA) 510(k) clearance for its Digital Pathology Module.

The module is part of the company’s overall pathology solution. The clearance allows clinicians to use it with Leica Biosystems’ AT2 DX scanner.

Furthermore, healthcare providers in the US can use the digital pathology solution for primary diagnostics. It is already in use in the country for research and tumour boards.

Pathologists can use the module for instant access to existing and historical images and related data, using digital images of tissue samples instead of physical glass slides.

In addition, the solution will allow efficient second opinions, remote reading, specialist consultations and integrated diagnostics.

Sectra president Mikael Anden said: “I am excited that with the FDA approval, we are now able to offer US healthcare providers a digital pathology, offering with a proven track record of use for full-scale primary diagnostics and large volumes.

“Our solution makes it possible for pathologists across the country to continue their important work from home without the need for a microscope. We look forward to providing uninterrupted pathology reading in these challenging times.”

The module enables clinicians to use a single solution for their medical imaging requirements across all specialities and allows integrated diagnostics.

In addition, it improves efficiency and patient care by providing deeper cooperation and the ability to access other departmental images and information.

Sectra CEO and president Dr Torbjörn Kronander said: “Pathology is the next huge digitisation of healthcare. The use of glass slides limits growth in today’s increasingly digital environment, especially in consolidated health care systems where potential synergies cannot be reached unless pathology is digitised.

“Our solution opens up new opportunities in the US where we can point to our successes in Europe in large production centres.”

31 MARCH 2020

ZOLL Medical receives FDA approval for TherOx System

30 MARCH 2020

Medtronic reports positive data from study of Evolut TAVR System

Medtronic has reported positive data from the Low Risk Bicuspid Study, which evaluates the use of the Evolut transcatheter aortic valve replacement (TAVR) system in patients with bicuspid aortic valve stenosis at low surgical risk.

The 150-patient single-arm study reported low rates of all-cause mortality or stroke at 30 days (1.3%) with a low rate of serious procedural complications.

It also showed a 95.3% device success rate and a low rate of serious procedural complications, including no annular ruptures or aortic dissection.

In addition, the outcomes showed a low rate of all-cause mortality and a low rate of disabling stroke.

The study co-primary investigator Basel Ramlawi said: “These findings point to potentially less invasive treatment for patients who otherwise would undergo open-heart surgery due to their anatomical valve structure.

“We feel confident that these primary early outcomes provide additional evidence that the Evolut TAVR platform is a suitable treatment option for patients with bicuspid valves who have previously been left out of TAVR trials.”

The Evolut TAVR platform includes the Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems.

It is indicated for symptomatic severe aortic stenosis (AS) patients across extreme, high, intermediate and low-risk categories and for Bicuspid valve patients at intermediate risk.

AS affects 1.5 million individuals globally and is one of the most common valvular heart diseases in the world.

Bicuspid aortic valve disease (BAVD) is a congenital heart defect, affecting approximately 2% of the general population. It is an abnormality of the aortic valve, leaving the patient with two functional valve leaflets instead of the more common three leaflets (tricuspid).

Patients with BAVD were generally excluded from prior TAVR trials due to concerns of asymmetric calcification, an elliptical shape, potential incomplete valve expansion, procedural technical concerns and other risk factors.

In September 2019, Medtronic launched the Evolut PRO+ TAVR System in the US, following its approval from the Food and Drug Administration.