Genedrive Share Discussion Threads

[maxplus2] 24/3/2021 12:39

Looks like the Assay is being used in New York and received EUA from FDA. See Danaher rns.BREA, Calif., March 23, 2021 /PRNewswire/ -- Beckman Coulter, a clinical diagnostics leader, today announced that its Access SARS-CoV-2 IgG II antibody assay received U.S. Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The semi-quantitative assay measures a patient's level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU). Lenco Diagnostic Laboratories, one of New York City's largest privately-owned, full-service reference labs, is among the first to offer the test in its facilities across Brooklyn, NYC, and the tri-state metropolitan area. Lenco conducted an independent verification of the assay's performance and is highly satisfied with the quality of the results."To help in the fight against COVID-19, it is important that we partner with a company that has the reputation, quality, and testing accuracy like Beckman Coulter in meeting the needs of the people of New York," said Robert Boorstein, M.D., Ph.D., medical director, Lenco Diagnostics Laboratories. "This next step in COVID-19 antibody testing creates a pathway in helping us establish a quantitative baseline of different antibody levels and determine how a patient's immune response to COVID-19 is affected over time. We expect that clinicians will find this assay useful for monitoring the progress of a patient's COVID-19 recovery and assessing the immune response over time."The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 100% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at >/= 15 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing."Effective and high-quality diagnostic solutions are essential in the fight against COVID-19," said Shamiram R. Feinglass, MD, M.P.H, chief medical officer at Beckman Coulter. "Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual's immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development."

[thehitman1] 24/3/2021 12:29

I think this is due a bounce.

[thehitman1] 24/3/2021 12:28

and who are you?.

[richardp19] 24/3/2021 10:34

Results wnt be good

[pal44] 24/3/2021 08:45

Come on DB what are you doing fella sleeping on the job need to get some sales new out pronto ......

[blackvulture] 24/3/2021 07:53

Cytiva are opening a fast track lab in Hyderabad in India. Coincidence?.

[rayj1] 23/3/2021 19:01

126 ?? Wtf man

[hooded claw] 23/3/2021 08:39

Neo, just filter the bellend FFS

[neo26] 23/3/2021 00:15

Odx contracts leaked over month ago, price gone close to 200m, without margins its fair price.We get fda approval then large contracts are certainty.U wont be laughing then.

[rayj1] 22/3/2021 23:23

If it's anything like odx fireworks you know it's a little sparkle lol ha ha those idiots must have got so excited this morning only to see the price go down. Makes me laugh.

[neo26] 22/3/2021 22:51

htTps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm?lid=703727&lpcd=QLTFireworks i reckon

[pal44] 22/3/2021 21:50

Just hope we have not missed the boat need more sales and figures published come on GRD be good

[hooded claw] 22/3/2021 20:37

I am expecting an update on how it is going ...nothing more.

[loafofbread] 22/3/2021 19:44

Yes. Thursday.Thank you.

[neo26] 22/3/2021 19:40

Results are on thursday, live presentation om friday.They cant tap the indian mkt without fda approval, i think they are close.Europe also seeing more cases, if we cant sell the best pcr kit then obviously we have missed the boat.

[neo26] 22/3/2021 15:36

Hooded ClawInvestors shouldnt expect much with sales as its only been 6 weeks, they need time.Nice to see an update on how things goin, especially with fda.Beckman would have got the nod bwfore they started investing on our pcr kit..Imho

[hooded claw] 22/3/2021 15:09

There will be an update on BC commercial progress on Thursday. Sounds like a good idea as won't be much in the actual results themselves.

[hooded claw] 22/3/2021 14:56

"Its year end results, dec 20, beckman will get the contracts over time.

No one is expecting sales figures in these results."

Neo, while I completely agree on the above Walbrook has said there will be a BC update this week

[hooded claw] 22/3/2021 13:38

Why is it very odd? Been doing this kind of thing for a while now

[beergut] 22/3/2021 12:04

No change in the price for 2 hours very odd.

Looks like it is waiting to take inspiration from the US open, or for a takeover to be announced :-)

[neo26] 22/3/2021 11:15

It was ther last week also, but great anyway.Big week for gdr..

[yasyas1] 22/3/2021 10:43

Hey big jump. Whats going on??

[qs99] 22/3/2021 09:18

Looking strong at start of week....would be good to get a sales update! GLA and DYOR