Fly Intel: After-Hours Movers » 19:1304/0604/06/20
VMD, TWO, TMDX, LMNX, GSKY, BZH, KHC, SEAC, VRNS, CIM, BA, FLS
Check out the evening's…
Luminex reports Q1 revenue 'just over' $90M, consensus $83M » 16:3304/0604/06/20
Luminex announced Q1…
Luminex announced Q1 revenues of just over $90M, up approximately 10% over the first quarter of 2019 and approximately 8% above the top end of its previously communicated first quarter revenue guidance range of $82M-$84M. "During the first quarter, and in the face of a global pandemic, our diversified business performed very well and showcased both our flexibility and creativity. In these challenging times, our organization has stepped up and provided multiple solutions to the marketplace, including several recent Emergency Use Authorized SARS-CoV-2 tests," said Nachum "Homi" Shamir, President and CEO. "Through the tireless efforts of our front-line employees, we have ramped up manufacturing to accommodate the ever-increasing needs of our customers, both existing and new. We look forward to providing a more detailed analysis of our full results during our quarterly results call." The full financial results for the quarter and any changes to 2020 guidance and/or provision thereof, will be discussed on our first quarter earnings call, currently scheduled for May 11.
Luminex receives FDA EUA for ARIES SARS-CoV-2 Assay » 07:3404/0604/06/20
Luminex announced that…
Luminex announced that the FDA has issued an Emergency Use Authorization for its ARIES SARS-CoV-2 Assay for rapid detection of the virus that causes COVID-19. The assay runs on the ARIES System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no specialty training and minimal human interaction. Luminex also launched the NxTAG CoV Extended Panel last week after receiving an EUA from the U.S. FDA and Medical Device Authorization for importation or sale for Health Canada. The panel is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in as many as 96 samples in approximately four hours. To provide a more complete picture of a patient's respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG Respiratory Pathogen Panel. Luminex is actively supporting laboratories in the U.S., Asia, and Europe with their testing, and the company has expanded its manufacturing capacity to produce up to 200,000 ARIES SARS-CoV-2 tests per month, in addition to 300,000 NxTAG tests per month, with the majority of this capacity focused on SARS-CoV-2.
|Over a week ago|
Luminex receives $642,450 in funding from BARDA » 07:3903/3103/31/20
Luminex announced that it…
Luminex announced that it has received $642,450 in funding from the Biomedical Advanced Research and Development Authority, or BARDA. These funds will help support development, testing, and submission later this week for an Emergency Use Authorization, or EUA, for the ARIES SARS-CoV-2 Assay. This assay will run on the company's sample-to-answer ARIES System, an FDA-cleared, automated molecular diagnostics platform for moderate complexity labs. The ARIES SARS-CoV-2 Assay is designed to provide rapid answers in patients believed to have COVID-19, generating results in approximately two hours. It can be run on 6-unit and 12-unit ARIES(R) Systems for labs seeking a medium-throughput solution with minimal hands-on time required. The assay will improve upon existing laboratory-developed tests for SARS-CoV-2 on the ARIES(R) System by eliminating the need to purchase and incorporate additional reagents, making the test easier to run and allowing labs to start testing immediately upon performance verification. Luminex intends to price the ARIES SARS-CoV-2 Assay below current government reimbursement levels in order to prevent additional financial burden on customers and the healthcare system during the COVID-19 pandemic.
Luminex receives FDA EUA for NxTAG CoV Extended Panel » 16:1103/2703/27/20
Luminex Corporation announced that the FDA has issued an Emergency Use Authorization, or EUA, for its NxTAG CoV Extended Panel. The intended use of this multiplex test is the detection of the SARS-CoV-2 virus. High complexity molecular laboratories can now use the NxTAG test on Luminex's easy-to-use, compact MAGPIX System to rapidly detect the virus that causes COVID-19 disease for up to 96 patients in approximately 4 hours. The MAGPIX System, on which the NxTAG panel runs, utilizes Luminex's unique bead-based chemistry, which makes the system both easy to run and to use. This combination provides a cost-effective testing solution for the rapid delivery of test results. Luminex responded to the coronavirus outbreak by developing the NxTAG CoV Extended Panel as a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2. To provide a more complete picture of a patient's respiratory health, the NxTAG CoV Extended Panel can also be run in parallel with the NxTAG Respiratory Pathogen Panel. Luminex is actively supporting laboratories in the US, Asia, and Europe with their testing, and the company has expanded its manufacturing capacity to produce up to 300,000 NxTAG tests per month, with the majority of that capacity focused on SARS-CoV-2.
Luminex COVID-19 test made available under FDA Emergency Use Authorization » 13:5903/2703/27/20
A fact sheet for…
A fact sheet for healthcare providers dated March 27 that was posted to the FDA website reported that the FDA has made the NxTAG CoV Extended Panel Assay available under an emergency access mechanism called an Emergency Use Authorization. "The EUA is supported by the Secretary of Health and Human Service's declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19," the fact sheet noted. Reference Link
Luminex to submit EUA for an ARIES SARS-CoV-2 Assay next month » 07:3703/1303/13/20
"As part of our…
"As part of our broader work to make a difference in the battle against the coronavirus pandemic, Luminex is supporting laboratories in their efforts to detect and diagnose cases of COVID-19," said Nachum "Homi" Shamir, President and CEO of Luminex. "Independent validation of LDTs on our ARIES System will help labs to quickly meet the high demand for testing around the world. We are honored that these clinical labs have chosen to develop their coronavirus tests using our ARIES platform and are pleased that this work can be easily reproduced at the hundreds of labs currently using the ARIES System." Along with these validation studies, labs across Europe and the United States are in the process of going live with their LDTs using the ARIES System, and Luminex intends to submit an EUA for an ARIES SARS-CoV-2 Assay next month. The platform uses real-time PCR technology that, when combined with its ability to run LDTs, is ideally suited for facilities that need to develop their own lab-specific testing for which there is no commercially available, FDA-cleared assay. The system provides the flexibility to handle STAT or batch testing and is capable of running different assays simultaneously.
Luminex provides update on efforts to address coronavirus » 07:3503/1303/13/20
Luminex announced that…
Luminex announced that four independent clinical laboratories have validated laboratory developed tests for automated, rapid detection of the SARS-CoV-2 virus using the sample-to-answer ARIES System. These LDTs demonstrate that high complexity laboratories using the ARIES System can immediately add novel coronavirus diagnostics to their testing menu. This will be important for helping to address soaring demand for coronavirus tests and will allow laboratories to produce results in approximately two hours. Studies to verify the test parameters with contrived samples on the ARIES System were conducted by Baylor Scott and White Health (Temple, TX), Montefiore Medical Center (Bronx, NY), Geisinger (Danville, PA), and the University of Louisville (Louisville, KY). Luminex has also launched and begun shipping its NxTAG CoV Extended Panel (RUO), a unique multiplex panel that addresses the coronavirus pandemic using its existing bead-based NxTAG Technology. A number of labs in the Far East, Europe and North America have already validated this panel and are planning to go live with it this week. In addition, Luminex is planning to submit an EUA for this panel to the FDA by the end of this month.
|Over a month ago|
Luminex provides update on efforts to address coronavirus » 07:3403/0403/04/20
Luminex announced updates…
Luminex announced updates on the company's plans, progress, and capabilities in assisting laboratories to detect and diagnose cases of this novel coronavirus disease. "We have been working on multiple solutions to augment our NxTAG and ARIES offerings in order to facilitate and automate the detection of SARS-CoV-2," said Nachum "Homi" Shamir, President and CEO of Luminex. "These additional alternatives leverage our globally available instrument platforms and assay technologies. They should be especially helpful to laboratories throughout the United States, given the recently released guidance from the Food and Drug Administration concerning high-complexity testing under CLIA prior to Emergency Use Authorization for SARS-CoV-2. Offering multiple solutions is a key part of Luminex's focus on providing value and flexibility to our current and future customers. The assays we are working on will assist both laboratories and clinicians that need to detect SARS-CoV-2 on its own, as well as those that may need a more complete picture of potential causes of respiratory infections-including targets that are both common and novel in nature. In addition, Luminex's VERIGENE RP Flex Test, NxTAG RPP, and ARIES Flu A/B & RSV assays are all able to provide exclusion testing as laboratories grapple with the emerging COVID-19 situation during the flu/respiratory season. Given the expanding scope of this outbreak, it seems likely that we could be battling COVID-19 for the foreseeable future. We are unable to quantify at this time what, if any, material financial impact these efforts will have, and are not making any adjustments to our current expectations. We look forward to providing additional updates as they become available."
Morgan Stanley to hold a conference » 04:5503/0303/03/20
LMNX, PHG, CMCSA, SAUHY, SONVY
European MedTech &…
European MedTech & Services Conference will be held in London, England on March 2-3.