industry news

Mesa Biotech has secured a contract for up to $15.4m from the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) programme for its Accula SARS-CoV-2 Test.

The RADx programme was established by NIH to expand the range and scale up the availability of diagnostic tests for coronavirus.

Furthermore, the initiative intends to ramp up the daily testing capacity to approximately 2% of the US population by the end of this year.

Using a rapid-review process, the programme offers an independent evaluation of the technologies and the potential to scale. The programme has received over 650 proposals to date with seven being fast-tracked to RADx’s Phase II, the final stage of the process.

Testing technologies that progress to Phase II will be granted an appropriate budget from the programme to promote full clinical deployment on an accelerated timeline, as well as technical, business and manufacturing assistance.

Mesa Biotech’s Accula SARS-CoV-2 Test is a visually read test that uses reverse transcription-polymerase chain reaction (RT-PCR) technology to detect the virus through nasal swab samples. It is designed to deliver results in 30 minutes at the point of care (POC).

The test received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in March.

Mesa Biotech president and CEO Ingo Chakravarty said: “We are humbled by the confidence and support that we have received from the federal government and honoured to be among the select group of initial companies to enter Phase 2 of the RADx programme.

“We continue to diligently work for the American people to increase supply for near-term Covid-19 testing, as well as innovate game-changing solutions to fight the current pandemic and future public health threats.”

US-based Accumen has announced a partnership agreement with medical device company Spectrum Solutions to offer Covid-19 saliva testing kits in the US.

The company received Food and Drug Administration (FDA) emergency use authorisation (EUA) in April for its saliva testing for the diagnosis of Covid-19. The authorisation mandated saliva collection solely using Spectrum’s SDNA-1000 saliva collection device based on a trial with Rutgers University.

The SDNA-1000 delivers 100% neutralisation of the live virus, mitigating risk and the threat of unnecessary exposure.

In addition, it can preserve and stabilise viral RNA transcripts for transport in extreme and varying temperatures for more than 14 days and for approximately one year after collection in ambient storage.

Furthermore, the Spectrum saliva collection kit has been designed to offer accurate and sensitive test results and reduce sample collection errors.

The at-home self-collection kit also helps to reduce the labour required for collection and decrease the use of personal protective equipment (PPE).

Accumen Corporate Supply Chain vice-president Eric Jurinic said: “Accumen has been partnering with its clients to strengthen their laboratory supply chain for more than ten years. Early in the Covid-19 crisis, we identified supply chain gaps and began coordinating resources to meet those evolving needs.

“As the crisis continued, we were able to provide critical testing supplies like nasopharyngeal (NP) swabs, media and personal protective equipment for our clients and we later made those resources available to other health systems and laboratories across the country to help increase testing efforts.”

Accumen is currently offering full kit or saliva collection device-only orders and implementation support services.

The company also offers laboratory, imaging, blood management rapid response tools and other strategic pandemic resources through the Covid-19 Resource Centre.

Becton, Dickinson and Company (BD) has received a $24m investment from the US Government to support the manufacturing scale-up of Covid-19 diagnostic tests.

The investment has been made by the US Department of Defense and the US Department of Health and Human Services.

The fund will be used to expand the manufacturing capabilities of the company’s BD Veritor Solution for Rapid Detection of SARS-CoV-2.

The company plans to use the additional capital to boost domestic production and increase total production capacity by 50%.

It is estimated that the investments will ramp up global production to more than 12 million test kits a month by the end of February 2021.

BD Integrated Diagnostic Solutions president Dave Hickey said: “Making Covid-19 diagnostic tests widely available is critical to expanding rapid detection of Covid-19 infections and mitigating the impact of the disease by identifying affected patients, quickly quarantining infectious individuals and tracing their contacts.

“This investment will bolster our US manufacturing capabilities, helping us quickly scale our production of point-of-care Covid-19 tests to ensure we have a robust supply for our US customers.”

BD obtained the FDA emergency use authorisation (EUA) for the BD Veritor Plus SARS-CoV-2 antigen assay earlier this month. The assay was developed to be used in healthcare settings for the rapid diagnosis of Covid-19 in symptomatic individuals.

The company plans to leverage the US-installed base of over 25,000 BD Veritor Plus instruments to fuel the deployment of the SARS-CoV-2 assay across the country.

Earlier this month, BD formed a strategic partnership with the Biomedical Advanced Research and Development Authority (BARDA) in the US to establish new manufacturing lines for injection devices.

The company recently secured additional orders from the US and Canada governments for 177 million syringes and needles to support Covid-19 vaccination efforts.

US-based medical device company CHF Solutions has signed a distribution agreement with SysteMedic to make its ultrafiltration therapy available for patients in Israel and Palestine.

It is the company’s second distribution partnership in the Middle East region and it expands the commercial availability of Aquadex SmartFlow ultrafiltration therapy to 16 countries outside the US.

Aquadex SmartFlow system is a fluid management platform. The system uses ultrafiltration to stabilise patients, experiencing fluid overload, and enable providers to manage their patients’ fluid balance with precision, control and ease.

Approximately 2% of the Israeli population is estimated to suffer from heart failure, while 90% of hospitalisations among heart failure patients are due to the signs and symptoms of fluid overload.

CHF Solutions chairman and CEO John Erb said: “CHF Solutions is committed to making ultrafiltration therapy available for patients throughout the world. Our partnership with SysteMedic demonstrates continued execution on that strategy.

“Subject to regulatory approval, we look forward to working with SysteMedic to make the simple, flexible and smart Aquadex SmartFlow system available to patients in Israel and Palestine, suffering from fluid overload due to heart failure, cardiovascular surgery and other critical care conditions.”

Commenting on the agreement, SysteMedic general manager Arik Yanco said: “We are very excited to work with CHF Solutions to introduce their ultrafiltration technology to Israel and Palestine.”

“We believe the Aquadex therapy will make a difference in the quality of lives of patients and look forward to a successful partnership.”

Israel-based SysteMedic imports and markets medical products and technologies to hospitals, health services, private clinics, home care, government and military customers in Israel and Palestine.

US-based medical device company LKC Technologies has secured the Brazilian Health Regulatory Agency (Anvisa) approval for the RETeval device and associated Sensor Strips skin electrodes.

The RETeval device is a portable, handheld, functional diagnostic device for medical professionals to diagnose patients with diabetic retinopathy, glaucoma, CRVO, pediatric nystagmus and inherited diseases.

The device provides ‘highly reliable’ results without the need for dilation by using a patented, built-in pupillometry.

LKC’s patented disposable Sensor Strips are designed to offer ‘safe and accurate’ testing. They are comfortable for patients and easy to apply.

Furthermore, they are said to be specifically helpful in the pediatric market and where the use of corneal electrodes is not possible.

The company is collaborating with Centro MédicoLogístico (CML) to offer physicians broader access to RETeval device globally.

LKC Technologies president Jim Datovech said: “The Brazilian approval of the RETeval device and the Sensor Strip skin electrodes is a landmark moment for both LKC and the ocular health of the Brazilian population from big cities to the most remote of locations.

“Building on its history, LKC is driven to make functional diagnostics available to all clinicians, aiding in faster and more accurate diagnosis of complex eye diseases. We are grateful for the dedication of CML and the LKC team for their extraordinary commitment to make this approval a reality.”

LKC develops devices for the aid and management of ophthalmic disorders. The company was founded by Jerome Leight, Sigmund Krassowsky and Frank Chenin 1975.

Cerus Endovascularhas received CE Mark approval for the CerusEndo MC 021 microcatheter, which enables physicians to access tortuous neuro vasculature and deliver therapeutic devices to intended targets.

The CerusEndo MC 021 microcatheter, which has already secured the US Food and Drug Administration (FDA) approval, is the company’s first microcatheter to obtain European regulatory approval.

CerusEndo MC 021 microcatheter offers improved proximal support by providing better deliverability and responsiveness in physicians’ hands. It is available in multiple distal flexible profiles.

Cerus Endovascular president Stephen Griffin said: “We remain committed to meeting the ever-increasing needs of the interventional neuroradiologist community, and with that in mind, our team has clearly identified a range of increased performance demands required of a go-to intracranial access microcatheter.

“As a result, we have expanded our key 021 platform so that it can deliver a wider range of devices than it was originally designed for, including stents, braided flow diverters and stentrievers, for treatment of both hemorrhagic and ischemic strokes. In particular, the 021 ensures predictable stability and control when delivering larger and braided devices through the device lumen.”

The company expects to begin the commercial sales of the newly CE-Marked product in the fourth quarter of this year.

In April, Cerus Endovascular secured CE Mark for the Neqstent Coil Assisted Flow Diverter device designed for the treatment of intracranial aneurysms.

Earlier this year, the company raised $19m in a Series B financing from institutional investors to implement the go-to-market strategy and expand the product portfolio.