LumiraDx Ltd

LumiraDX Ltd. is a next-generation point of care diagnostics company, which engages in the provision of an innovative diagnostic platform that supports a menu of tests with lab-comparable performance at the point of care. The firm's diagnostic testing solutions are being deployed by governments and healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. It also has a comprehensive portfolio of COVID-19 testing solutions from the lab to point of need. The company was founded by Ronald Zwanziger, David Scott, and Jerry McAleer in 2014 and is headquartered in London, the United Kingdom.

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LumiraDX Ltd. is a point of care diagnostics company, which engages in the provision of a diagnostic platform that supports tests with lab-comparable performance at the point of care. The company was founded by Ronald Zwanziger, David Scott, and Jerry McAleer in 2014 and is headquartered in Waltham, MA.

LONDON , July 21, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care (POC) diagnostics company, today announced the pricing of its underwritten public offering of 43,000,000 common shares at a price to the public of $1.75 per share. All of the common shares are being offered by LumiraDx.

LumiraDx Announces Pricing of Public Offering of Common Shares and Concurrent Private Placement

LONDON , July 19, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care (POC) diagnostics company, today announced that it has commenced an underwritten public offering of 40,000,000 common shares. All of the shares in the proposed offering are to be sold by LumiraDx.

LumiraDx Announces Proposed Public Offering of Common Shares

Next-generation antigen test system built on more than eight years of research and backed by industry leading microfluidic experts The Amira System includes the Amira Analyzer, Amira SARS-CoV-2 Ag test strips, swabs and sample preparation materials Designed to provide lab-comparable performance at a lateral flow-comparable price LONDON , June 9, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced that it has achieved CE Mark for the Amira System, its new testing system that provides low-cost, highly sensitive COVID-19 testing. The Amira Analyzer reads the included Amira SARS-CoV-2 Ag test strips and returns a result in just 15 minutes.

LumiraDx Achieves CE Mark for COVID-19 Antigen Test on Amira, its New Low-Cost Testing System

LumiraDx Ltd (NASDAQ: LMDX) shares are trading higher by 10.31% at $4.28 after the company announced it achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. LumiraDx says the SARS-.

Why LumiraDx Shares Are Rising Today

LONDON , June 8, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX) today announced that it has achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. These high-sensitivity and high-throughput tests help to expand testing capabilities across the globe.

LumiraDx Receives CE Mark for Two Multiplex Tests: LumiraDx Dual-Target SARS-CoV-2 STAR Complete and LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete

The LumiraDx NT-proBNP and the LumiraDx D-Dimer tests are currently the only quantitative direct fingerstick assays produced for each test. Run on the highly portable LumiraDx Platform, they are designed for near-patient testing with connected results in 12 minutes and 6 minutes, respectively  The LumiraDx NT-proBNP test is a rapid microfluidic immunofluorescence assay for the quantitative measurement of NT-proBNP in human capillary, venous whole blood and plasma specimens.

LumiraDx Expands its Cardiovascular Testing Portfolio with CE Marking of its NT-proBNP Test and new Exclusion Claim for its D-Dimer Test

Rapid microfluidic immunofluorescence assay intended for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes The automated, quantitative fingerstick assay is run on the highly portable LumiraDx Platform and designed for near-patient testing with connected results in under seven minutes Rising global rates of diabetes presents growing need for broader access and an easier, more connected solution for HbA1c testing in community-based healthcare settings such as primary care and retail pharmacy Available on the same Point of Care (POC) Platform as LumiraDx's high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool, SARS-CoV-2 Ag Ultra as well as INR, D-Dimer and CRP tests* LONDON , May 26, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its HbA1c test has achieved CE Marking. Used with the LumiraDx Platform, the test provides results in under seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of care.

LumiraDx HbA1c Test Achieves CE Mark, Addresses Growing Global Need for Diabetes Screening and Monitoring with its Next-Generation Point of Care Diagnostic Platform

LONDON , May 20, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19. The LumiraDx antigen test is a microfluidic immunofluorescence assay that delivers results for the direct and qualitative detection of nucleocapsid protein antigen in nasal swab specimens collected from the patient.

LumiraDx Receives WHO Emergency Use Listing for SARS-CoV-2 Ag Test

Results in just 5 minutes from sample application, aids in fast clinical decision-making at point of care (POC), helping to inform treatment decisions and prevent the further spread of infection, while also increasing testing throughput Run on the multi-assay LumiraDx Platform, the Ultra Test's innovative strip design builds on the company's microfluidic immunofluorescence technology enabling faster reaction times without sacrificing sensitivity   Available on the same POC Platform as LumiraDx's high sensitivity SARS-CoV-2 Antigen, Flu A/B, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool as well as INR, D-dimer and CRP tests* LONDON , May 19, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its SARS-CoV-2 Ag Ultra Test achieved CE Marking. The Ultra test provides digital and connected results in just five minutes with high sensitivity, making it one of the fastest and most sensitive COVID-19 antigen tests available.

LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Achieves CE Marking

LumiraDx Ltd (NASDAQ:LMDX ) Q1 2022 Earnings Conference Call May 11, 2022 4:30 PM ET Company Participants Colleen McMillen – Vice President-Communications Ron Zwanziger – Chairman and Chief Executive Officer Dorian LeBlanc – Chief Financial Officer Pooja Pathak – Chief Product Officer Conference Call Participants Vijay Kumar – Evercore ISI Jeffrey Cohen – Ladenburg Thalmann Andrew Cooper – Raymond James Operator Hello, and welcome to LumiraDx First Quarter 2022 Earnings Call. All participants will be in the listen-only mode.

LumiraDx's (LMDX) CEO Ron Zwanziger On Q1 2022 Results - Earnings Call Transcript

Strong Growth in Instruments Delivered to Customers and Continued Innovation on our Platform LONDON , May 11, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care (POC) diagnostics company, today announced financial and operational results for the first quarter ended March 31, 2022. For the first three months of 2022, LumiraDx revenue was $126.4 million compared to $106.9 million for the first quarter of 2021 Customer install base grew to 25,000 Platforms compared to 21,000 at year-end 2021, lead by new instrument placements with U.S. customers Q1 revenues for COVID related products were substantial in January at the height of the Omicron wave Cash balance at March 31 was $166.0 million; $50 million in financing expected to close in Q2 to fund further instrument placements "We had a strong start to the year with increased revenues, instrument shipments and validation of our Platform by health systems and global health partners for an expanding menu of tests," said Chairman and CEO Ron Zwanziger.

LumiraDx Reports First Quarter 2022 Results

LONDON , April 29, 2022 /PRNewswire/ -- LumiraDx Limited  (Nasdaq: LMDX), a next-generation point of care (POC) diagnostics company, announced it will release its first quarter financial results on Wednesday, May 11, 2022. On the day of the release, LumiraDx will host a conference call and webcast at 4:30 PM Eastern Time to review the financial results and business highlights.

LumiraDx to Announce First Quarter Financial Results and Host Quarterly Conference Call on May 11

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LumiraDx Limited (LMDX) CEO Ron Zwanziger On Q4 2021 Results - Earnings Call Transcript

LONDON, March 10, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq:LMDX), a next-generation point of care (POC) diagnostics company, today announced financial and operational results for the fourth quarter and full year ended December 31, 2021. Full year 2021 revenues of $421.4 million up from full year 2020 revenue of $139.2 million, as the pandemic accelerated momentum on our long-term growth strategy Fourth quarter 2021 revenue of $118.3 million rose sequentially compared to strong Third Quarter 2021 revenue of $109.1 million and year over year versus fourth quarter 2020 revenue of $112.3 million Customer use of our Platform to support several tests including SARS-CoV-2Antigen, D-Dimer for diagnosing thrombotic conditions and CRP for antibiotic stewardship being credited for streamlining treatment and reducing cost and stress on health systems Customer instrument shipments total more than 21,000 Platforms as of December 31, 2021 Strong start to the year with an estimated 4,000 instruments to be shipped for the first quarter of 2022 and first quarter 2022 revenues expected to be similar to fourth quarter 2021 "LumiraDx's strong 2021 performance marks an inflection point in our strategy for transforming community-based diagnostics," said Ron Zwanziger, Chairman and CEO of LumiraDx.

LumiraDx Reports Fourth Quarter and Full Year 2021 Results

LONDON, March 3, 2022 /PRNewswire/ -- LumiraDx Limited  (Nasdaq:LMDX), a next-generation point of care (POC) diagnostics company, announced it will release its fourth quarter and full year 2021 financial results on Thursday, March 10, 2022. On the day of the release, LumiraDx will host a conference call and webcast at 8 AM Eastern Time to review the financial results and business highlights.

LumiraDx to Announce Fourth Quarter and Full Year 2021 Financial Results and Host Quarterly Conference Call on March 10

LONDON, March 1, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX) announced today that it entered into privately negotiated subscription agreements with certain investors pursuant to which LumiraDx agreed to sell and the investors agreed to purchase from LumiraDx (the "notes offering") $56.5 million aggregate principal amount of 6.00% Convertible Senior Subordinated Notes due 2027 (the "notes"). The lead investor in the notes offering was UBS O'Connor, with participation from Ron Zwanziger, the founder of LumiraDx.

LumiraDx Announces Pricing of $56.5 Million Convertible Notes Offering

The mean of analysts' price targets for LumiraDx Limited (LMDX) points to a 53.6% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.

Wall Street Analysts Believe LumiraDx Limited (LMDX) Could Rally 54%: Here's is How to Trade

LONDON, Jan. 14, 2022 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced that results from ongoing testing and monitoring of COVID-19 variants show its SARS-CoV-2 Antigen test detects the Omicron Variant.  In-house wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity to other variants.

LumiraDx Lab Analysis Confirms its COVID-19 Antigen Test Detects the Omicron Variant

LONDON, Jan. 11, 2022 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced preliminary results for the fourth quarter of 2021 as well as expected full-year revenue. The company anticipates 2021 full-year revenues of $422 million compared to 2020 revenues of $139 million and 2021 fourth quarter revenues of $119 million compared to 2020 fourth quarter revenues of $101 million.

LumiraDx has Commenced Shipments in Europe for its COVID-19 & Flu A/B Microfluidic Antigen Test

LONDON, Jan. 11, 2022 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its C-reactive protein (CRP) Test has achieved CE Marking. The LumiraDx CRP Test is a small, portable, fully automated, microfluidic immunoassay test used for the quantitative determination of C-reactive protein with results within four minutes.

LumiraDx CRP Test Achieves CE Marking

LONDON, Dec. 23, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its SARS-CoV-2 & Flu A/B Antigen Test has achieved CE Marking. The microfluidic immunofluorescence assay can quickly verify potential infection for patients suspected of influenza and/or COVID-19, helping to identify and differentiate the underlying cause of respiratory illness and to inform treatment decisions at the point of care.

LumiraDx COVID-19 & Flu A/B Rapid Antigen Test Achieves CE Marking

LONDON, Dec. 15, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX) today announced a partnership with digital health non-profit Audere, to offer a self-collected COVID-19 nasal specimen collection kit that has been authorized for use with the LumiraDx SARS-CoV-2 RNA STAR Complete assay to process self-collected samples. Audere's testing solution, HealthPulse@home, closely aligns with LumiraDx's continual efforts to increase testing access and support a growing number of testing needs.

LumiraDx Fast Lab Solutions Partners with Audere for At-Home Self- Collection Solution for use with SARS-CoV-2 RNA STAR Complete

SEATTLE--(BUSINESS WIRE)-- #covid19--Audere, a digital health nonprofit developing solutions to improve global health, announced that it has received an Emergency Use Authorization (EUA) for HealthPulse@home from the U.S. Food and Drug Administration (FDA).1 Using the solution's authorized labeling instructions, HealthPulse@home seamlessly allows CLIA-certified laboratories to bring their own self-collection COVID-19 specimen kits to market without needing to obtain their own FDA EUA. HealthPulse@home pro

Audere Receives FDA Emergency Use Authorization for HealthPulse@home COVID-19 Specimen Collection Test Kit

LONDON, Dec. 1, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX) announced today that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing has been reissued. The EUA now includes (1) testing of asymptomatic individuals, (2) pooling of up to five individuals, (3) access to 384-well configuration on validated open RT-PCR systems and (4) inclusivity of the detection of the novel SARS-CoV-2 Omicron variant (B.1.1.529).

FDA Reissues LumiraDx Fast Lab Solutions' EUA for SARS CoV-2 RNA STAR Complete Molecular Reagents to Allow High Throughput and Asymptomatic Testing Solutions

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