Respiratory Disease: Page 2

ThermoGenesis gets FDA nod for COVID-19 antibody kit
By LabPulse.com staff writers
The FDA letter means that ThermoGenesis can begin distributing the diagnostic kit, which detects the immunoglobulin M/immunoglobulin G (IgM/IgG) antibodies that result from infection with SARS-CoV-2, the virus that causes the COVID-19 respiratory disease.
April 15, 2020
2020 04 16 18 56 8041 Virus Coronavirus Sars Co V 2 400
Effectiveness of masks for preventing coronavirus is up for debate
By Samantha Black, PhD
The White House on April 3 issued guidance recommending that Americans wear face coverings to prevent infection with the SARS-CoV-2 virus but recommended that they wear "nonmedical cloth" coverings due to a shortage of surgical and N95 masks.
April 7, 2020
2020 04 07 20 27 8885 Doctors Masks Team 400
Co-Diagnostics garners EUA for COVID-19 test
By LabPulse.com staff writers
Clinical laboratories certified under CLIA can now use the test to detect the novel coronavirus that causes the respiratory disease COVID-19. The company said it began offering the product to CLIA labs last month, following the FDA's relaxation of regulations on testing, which paved the way for use prior to an EUA. The test had previously received the CE Mark in Europe.
April 6, 2020
2019 05 02 23 38 2538 Check Mark 400
AACC moves annual meeting to December
By LabPulse.com staff writers
The AACC meeting is still set to be held in person -- not virtually -- at Chicago's McCormick Place, which is currently designated to be a hospital for people with SARS-CoV-2 and the associated respiratory disease COVID-19.
April 5, 2020
2019 08 05 17 59 6641 Aacc 2019 400
Luminex coronavirus panel gets FDA emergency authorization
By LabPulse.com staff writers
The NxTag test is designed for use at high complexity laboratories on Luminex' Magpix system, which can handle specimens for up to 96 patients, with results available in approximately four hours, according to the company. Luminex noted that labs can run the CoV test alongside the company's respiratory pathogen panel, which allows differentiation of the new virus from other diseases that have similar symptoms.
March 26, 2020
2020 03 27 23 23 0945 Luminex Magpix 20200327234756
Bruker, Primer Design ink European distribution deal for coronavirus test
By LabPulse.com staff writers
The CE-IVD assay is designed for use on Bruker-Hain Diagnostics' GenoXtract (GXT) automated nucleic acid extraction devices with associated extraction kits, and it targets very high specificity for SARS-CoV-2, the virus implicated in the respiratory disease COVID-19. It is validated for respiratory samples (nasopharyngeal swabs, oropharyngeal swabs, and sputum) on commonly available laboratory thermocyclers. The kit includes all necessary reagents to produce up to 96 results in under two hours, according to the companies.
March 24, 2020
2020 03 25 23 27 0591 Hands Shaking Deal 400
Holder of Theranos patents draws fire for lawsuit
By LabPulse.com staff writers
News reports this week initially accused Labrador Diagnostics of trying to profit on the coronavirus crisis by filing the lawsuit. But the firm pointed out that its litigation against BioMérieux has nothing to do with intellectual property (IP) specifically related to SARS-CoV-2 diagnostics.
March 18, 2020
2020 02 28 19 00 9291 Gavel Legal Business 400
As COVID-19 crisis continues, other infectious diseases threaten
By Shara Rosen
As of March 16, the World Health Organization (WHO) had reported more than 137,000 confirmed cases and over 6,600 deaths worldwide from COVID-19, the respiratory disease caused by the SARS-CoV-2 virus. The diagnostics industry is rising to the challenge presented by the coronavirus pandemic, with test developers creating new assays to detect SARS-CoV-2 infection as lab operators ramp up throughput to meet skyrocketing demand.
March 17, 2020
2019 10 09 20 17 0927 Influenza Virus 400
Hologic secures emergency authorization for COVID-19 test
By LabPulse.com staff writers
The assay detects SARS-CoV-2, the virus that causes the COVID-19 respiratory disease. With the FDA authorization, Hologic's Panther Fusion automated molecular diagnostic platform can now be used to provide SARS-CoV-2 test results in less than three hours. Up to 1,150 coronavirus tests can be performed in a 24-hour period, according to the vendor.
March 16, 2020
2019 08 20 21 43 1377 Hologic Aacc 2019 400
FDA gives states, vendors more power in coronavirus fight
By Brian Casey
The FDA has been under heavy pressure to ease its regulations on diagnostics to get more tests into the field for the SARS-CoV-2 coronavirus, which causes the COVID-19 respiratory disease. Clinicians and public health authorities have claimed that not enough tests are available to meet demand, so the agency has made a series of regulatory changes over the last several weeks that relax its oversight.
March 15, 2020
2019 02 13 19 24 5396 Fda Logo V2 400
CMS adds new code for coronavirus tests
By LabPulse.com staff writers
The code (U0002) can be used by laboratories to bill for tests for SARS-CoV-2 infection and the respiratory disease caused by the virus, COVID-19, using diagnostics that are not provided by the U.S. Centers for Disease Control and Prevention (CDC). CMS issued the first code, U0001, to track patients tested with the CDC's own diagnostic for the coronavirus.
March 5, 2020
2019 10 24 21 35 9053 Lab Scientist 400
CDC again broadens testing criteria for COVID-19
By Emily Hayes
"This expands testing to a wider group of symptomatic patients," the agency explained. "Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested."
March 3, 2020
2020 03 04 23 53 6453 Cdc Meeting 400
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