LumiraDx wins CE mark for C-reactive protein test

[Image from LumiraDx]LumiraDx (NSDQ:LMDX) announced today that it received CE mark approval for its C-reactive protein PCR test.

London-based LumiraDx designed its LumiraDx CRP test as a small and portable microfluidic immunoassay test used for the quantitative determination of C-reactive protein, delivering results within four minutes.

According to a news release, the CRP measurement provides important information for the detection and evaluation of infection and inflammation, with a high CRP suggesting the need for antibiotic treatment in patients with symptoms of respiratory infection, especially with suspected pneumonia.

The test platform can be used in automated PCR testing to assess infection, tissue injury and inflammatory conditions and guide treatment decisions, while LumiraDx made it available on a single POC platform with its highly sensitive COVID-19/FluA/B antigen, COVID-19 antigen, COVID-19 antibody, COVID-19 Pool, INR and D-Dimer tests.

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LumiraDx goes public as SPAC deal closes

The LumiraDx platform and test strip [Image courtesy of LumiraDx]LumiraDx shares are trading at more than $8 apiece on the Nasdaq today under the symbol LMDX after the company completed its merger with a SPAC called CA Healthcare Acquisition Corp.

The point of care diagnostic testing company has a pipeline of more than 30 assays across common health conditions, including infectious diseases, cardiovascular diseases, diabetes and coagulation disorders. The LumiraDx has already found use globally, including CVS Pharmacy in the U.S. and the National Health Service and Boots in the U.K.

“LumiraDx was founded to disrupt current point of care diagnostic options by providing rapid and highly accurate results wherever the patient is,” LumiraDx CEO Ron Zwanziger said in a news release yesterday.

“Our testing technology, which allows us to rapidly scale and offer lab-comparable testing with fast results across health conditions, is impacting healthcare across market …

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MedTech 100 roundup: Industry roars back

In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels.

MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark set a week prior (April 2).

The industry’s rebound has been impressive, given that just over one month prior, the index had dropped to 102.16 points (March 8), having just set its all-time best of 110.96 on Feb. 15. Medtech companies had no seen that degree of a fall since October 2020.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 18.5% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.1% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall …

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DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

Derek Herrera and Kwame Ulmer are featured on this week’s DeviceTalks Weekly Podcast.

In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech.

Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the most. Herrera also explains how his military training is serving him so well in medtech and how the medical device industry would benefit from including more veterans in its workforce.

We’ll also hear from Kwame Ulmer, principal at Ulmer Ventures and a lecturer at UCLA Anderson’s School of Management, about an effort his helping to lead to update the landmark study compiled by Josh Makower in 2010. The study blasted a regulatory process that it called “unpredictable, inefficient and expensive.”

Its finding led to introspection and changes, according to…

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LumiraDx to start trading on Nasdaq

CA Healthcare Acquisition Corp announced today that it entered a merger agreement with LumiraDx that will take the company public.

London-based LumiraDx, a point-of-care diagnostics developer, will merge with CAHC with the combination reflecting a value of $5 billion for Lumira’s existing equity, according to a news release. Since its founding, LumiraDx has raised $700 million in equity capital, including investments from Morningside Ventures, U.S. Boston Capital Corporation, The Bill & Melinda Gates Foundation, Petrichor Healthcare Capital Management and others.

Among LumiraDx’s point-of-care diagnostic offerings is its high-sensitivity COVID-19 antigen test, which has been used by the NHS in the UK and has FDA emergency use authorization in the U.S. It also offers POC tests for COVID-19 antibodies, INR and D-Dimer, all of which are available in Europe.

Under the terms of the transaction, all current LumiraDx shareholders will retain the…

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LumiraDx warns on false-positives with SARS-CoV-2 antigen test

LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test.

The company received a customer complaint regarding a suspected false-positive result with the antigen test on Dec. 29, 2020. An investigation into the complaint identified a manufacturing issue that resulted ina. small number of sequential test strips in certain batches having the potential to produce false-positives.

LumiraDx determined that approximately 1% of test strips are affected within 24 lots that were distributed in Europe. No reports of patient harm were presented to the company in relation to the issue.

The company identified the root cause of the issue and immediately implemented changes to its manufacturing process and updated its QC release and test procedures to reflect such changes.

In order to continue testing with the LumiraDx SARS-CoV-2 Ag test, users must install software version 1.21 immediately, as the software identifies th…

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FDA issues EUA for LumiraDx point-of-care COVID-19 antigen test

LumiraDx announced today that it received FDA emergency use authorization (EUA) for its LumiraDX SARS-CoV-2 point-of-care antigen test.

London-based LumiraDx’s test is designed to detect antigen nucleocapsid protein from a nasal swab and provide results in less than 12 minutes from sample application in symptomatic patients, according to a news release.

In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement compared to PCR in patients tested within 12 days of the onset of symptoms, making it what the company touts as the fastest, most sensitive antigen point-of-care test commercially available at this time.

LumiraDx intends to begin shipping its COVID-19 antigen tests by the end of August with a plan in place to produce 2 million tests in September before ramping up to 10 million in December.

“Actionable diagnostic results at the point of care lead to better health outcomes,” LumiraDx CEO …

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