FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV

The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription.

Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA.

Users can self-collect a nasal swab sample at home and send it to Labcorp for testing. It can identify and differentiate influenza A and B (the flu), respiratory syncytial virus (RSV) and SARS-CoV-2, the virus causing COVID-19. Results are delivered through an online portal, with healthcare provider follow-up for positive or invalid test results.

Samples can be self-collected by individuals 18 years and older on their own, by those 14 and older with adult supervision, or with adult assistance for individuals aged two years and older.

“While the FD…

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Labcorp launches at-home collection device for diabetes risk testing

[Image from Labcorp]Labcorp (NYSE:LH) announced today that it launched an at-home collection kit that measures HbA1c from a small blood sample.

Burlington, North Carolina-based Labcorp’s first-of-its-kind diagnostic offering uses a collection device from Weavr Health and is offered through its Labcorp OnDemand platform.

Get the full story at our sister site, Drug Delivery Business News.

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Labcorp, Getlabs launch home diagnostic collection service

Labcorp (NYSE:LH) announced today that it will collaborate with Getlabs to launch a convenient, at-home diagnostic service.

Getlabs for Labcorp combines the company’s diagnostics with Getlabs’ phlebotomy service to test consumers in the comfort of their own homes, allowing individuals to schedule an at-home blood draw or specimen collection when convenient for them.

According to a news release, appointments are available through Labcorp’s website, while Getlabs provides at-home appointments performed by its full-time phlebotomists at a convenience fee starting at $25.

The offering is available in 50 U.S. markets, covering more than 50% of the U.S. population, Burlington, North Carolina-based Labcorp said. The company added that it complements its nearly 2,000 patient service centers (PSCs).

“We want to make it easy for people to manage their health and this collaboration with Getlabs significantly expand…

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Labcorp launches on-demand platform for purchasing diagnostics

Labcorp (NYSE:LH) announced today that it launched Labcorp OnDemand to ease the experience of using the company’s diagnostics.

Burlington, North Carolina-based Labcorp’s Labcorp OnDemand provides a platform on which individuals can purchase tests online, collect samples in their own home or schedule test appointments at one of Labcorp’s 2,000 patient service centers.

The OnDemand platform includes a suite of the company’s most commonly used tests, including wellness, allergy, COVID-19, women’s health and fertility tests, according to a news release. Through Labcorp OnDemand, the company’s Pixel by Labcorp COVID-19 PCR and combined COVID-19 + flu at-home collection kits are available and will continue to be available at zero upfront out-of-pocket costs for those who meet clinical guidelines.

Labcorp expects to make additional Labcorp OnDemand test kit options available through physicians, health plans and employers thro…

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Baxter, 3M, Abbott near the top of Newsweeks’ most reponsible companies list

Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined environmental, social and corporate governance performance assessments.

Baxter, 3M, Abbott and BD (NYSE:BDX) were among the highest-ranking big-name medical device makers. Cancer diagnostic company Illumina was the highest-ranking company under the healthcare and life sciences umbrella, sitting in second behind HP.

In sixth sat Baxter, registering an overall score of 89.5 points, with its highest performance coming in environmental i…

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LabCorp launches flu-COVID diagnostic combo

Laboratory Corporation of America (NYSE:LH) announced today that it launched its COVID-19, influenza A/B and RSV diagnostic combo.

The single-panel test is designed to detect multiple types of infections including the novel coronavirus, the flue and respiratory syncytial virus (RSV), helping doctors diagnose patients and inform decisions for treatment options.

Burlington, N.C.-based LabCorp’s testing method is aimed at easing the strain that could be put on the healthcare system in the U.S. if there is a significant flu/RSV season in which the symptoms are similar to COVID-19 and other respiratory viruses, according to a news release.

LabCorp is offering the test through doctors, hospitals and other authorized healthcare providers in the U.S., while the company has submitted an application to the FDA to offer the combined test through its Pixel by LabCorp collection kit to add convenience and accessibility.

The Pixel by LabCorp at-home test …

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Hologic applies for pooled COVID-19 testing nod

Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing.

Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July, as did LabCorp, in an EUA reauthorization. Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing the testing method in June.

The FDA is touting pooled-sample testing as more efficient than individual tests, meaning fewer testing supplies are used and more tests can be run at the same time, allowing patients to receive their results more quickly in most cases. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative, according to the agency.

Qu…

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LabCorp COVID-19 test may be used on asymptomatic people

The FDA on Friday added two new indications for the use of a Laboratory Corporation of America (NYSE:LH) COVID-19 RT-PCR diagnostic: to test people who have no symptoms of the virus or have no reason to believe they’ve been exposed; and to allow pooled testing of up to five samples from different people.

The test, which received an emergency use authorization March 16, 2020, may now be used to screen people as they return to work and school. The company provided scientific data showing that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19, according to the FDA.

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