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COVID-19 IVD field gets more crowded; heart docs give insight on COVID-19 impact; ventilator production continues ramp-up; IVD innovation for future outbreaks and other decentralised testing applications; Medtronic in right direction for US renal denervation come-back.
FDA-authorised coronavirus test list gets longer
The past week has seen more additions to the US FDA’s list of COVID-19 tests that have received Emergency Use Authorisations, including Abbott’s point-of-care molecular test that is said to generate results in under 15 minutes. This test runs on the ID NOW analyser, which the company said is the most widely used molecular point-of-care testing platform in the US today. Whilst more molecular diagnostic tests are joining this list, there is also increasing noise around the use of antibody tests - which measures immunity to COVID-19, not the active infection - in the field. A number of companies this week indicated they had launched an antibody COVID-19 test, including BD, Chembio and BODYSPHERE. These companies have not received FDA EUA for their respective tests (although there was a bit of mix-up on BODYSPHERE's part), but at the time of writing this article, it was announced Cellex's qSARS-CoV-2 IgG/IgM rapid test had become the first antibody-based test that was officially authorised for diagnosing COVID-19 infection.
COVID-19 puts brakes on non-critical heart procedures
The widespread halt on elective procedures - partly due to COVID-19 safety measures, partly due to the channeling of almost all healthcare resources to care of COVID-19 patients - means medical device companies are feeling pressure on their top-line. But certain specialties would likely be more affected than others, so FirstWord MedTech ran a snap-poll this week to assess what impact the pandemic has had on cardiology practices. Heart patients are deemed to be at higher risk of becoming more critically ill should they contract the infection, so unsurprisingly, our poll showed that cardiologists are seeing a significant reduction in patient flow into their clinics. Respondents confirmed that they are postponing non-urgent procedures, but indicated that they are not delaying them for too long. For full results of our snap poll, see Physician Views Results: Cardiologists are postponing elective procedures, but not for too long
[We are also running a similar poll within the orthopaedic physician community - look out for the results of that survey next week.]
Ventilator production ramp-up far from slowing down
Medtronic this week made the unprecedented move to publicly share the design specifications for its Puritan Bennett 560 ventilator, in a bid to meet the continuously rising demand for these devices to help COVID-19 patients. The announcement follows a proliferation of cross-industry collaboration seen in the last few weeks - bringing together the likes of GE Healthcare and Ford, Dyson and TTP - as manufacturers all around the world strive to boost ventilator production of these life-saving devices. But are there issues, like confidentiality or product liability to be aware of in these partnerships? FirstWord MedTech spoke to an IP lawyer from Goodwin Procter to find out - see The Wider View: Should medtech companies be breathing easy around ventilator collaborations?
Novel nanofluidic-based IVD could offer testing solution for future disease outbreaks
The funding environment may be suffering as a result of the COVID-19 pandemic but Belgian start-up miDiagnostics announced this week it has successfully completed a $15 million round to advance development of its nanofluidic-based diagnostic technology. The test card uses silicon chips to conduct all the fluidic handling steps and the analysis is carried out by a reader the size of a credit card terminal. CEO Nicholas Vergauwe said the test could be designed to detect and measure virtually any biomarker in the body, be it cells, nucleic acids, proteins or small molecules. And as the silicon chip in the test card can be manufactured using the same processes as the silicon chips commonly used in our smartphones and computers, miDiagnostics’ test can be produced at high volume and cost-effectively. Vergauwe believes the company’s technology would enable testing in very localised settings, and its broad applications could encompass infectious disease testing - while it may not be ready for use in the current COVID-19 pandemic, it could be deployed for the anticipated resurgence of this coronavirus and other infectious disease outbreaks. See One To Watch: miDiagnostics seeks to move the needle in decentralised testing with nanofluidics to get a low-down on this start-up’s technology.
Medtronic’s SPYRAL data put it on path for US renal denervation comeback
Ten years since it acquired the technology from Ardian for $800 million and a highly-public failed pivotal trial later, Medtronic’s Symplicity Spyral renal denervation system looks to be making a return and is proving its mettle as a viable treatment for patients who had drug-resistant hypertension and were off anti-hypertensive medication. At the annual meeting of the American College of Cardiology, held virtually due to the COVID-19 pandemic, the company announced three-month results from its SPYRAL HTN-OFF MED sham-controlled pivotal trial. The results showed that patients treated with Symplicity Spyral had a statistically significant reduction in all blood pressure measures compared to those in the sham group. Blood pressure reductions were sustained consistently throughout the day and nighttime periods, which may offer an important benefit as cardiovascular risk is higher during the nighttime period. The Symplicity Spyral is already sold in 60 countries but has yet to be approved by the FDA (although it is designated as a breakthrough device). These results should bring it closer to getting that elusive stamp of approval from the US regulator.
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