Discover and read the best of Twitter Threads about #abdx

Most recents (3)

Mologic CE marked AffiDX for professional use, CE mark with #avct not Med19 AffiDX solely an avct brand. Med19 CE self use mark for Meduflow, EU CE mark solely Med19’s for Meduflow not avct. Professional & self use CE marks differ in use, both need separate CE marks.

1/23
Med19 have done all the hard work re: lay user study, filing all docs for CE mark for self use with EU notified body, as well as the money and time spent in obtaining CE self use mark for Meduflow. Med19 will be looking to keep and make a serious return on their investment

2/23
I suspect main points under license agreement between #avct Med19 would be:- use Affimer IP in Meduflow, Med19 achieve minimum yearly sale targets, which global territories (if not covering all world), royalty % per test sold, duration of license agreement,

continued…

3/23
Read 24 tweets
1/8
Here in Germany, we have already reached the point that my local grocery shop is selling rapid antigen tests.

Their product of choice is Hotgen, produced by a company out of Beijing.

Claims SENS 95.3% and SPEC 99.13% with the anterior nasal method.

#AVCT #ABDX #ODX
2/
There is now an unbelievable number of different products on the market in Germany, with the most popular being fairly local names, Roche and Siemens.

Both of these tests are being employed in school and kindergartens. Both employ nasal swab.

Schools testing twice weekly.
3/
Kindergartens are giving parents two tests per week and encouraging their use.

The Roche test is essentially the SD Biosensor test the Siemens is Healgen. Both of which went through Porton Down but apparently weren't contracted.

Having spent so long studying the market,
Read 8 tweets
Quick recap on @avacta #AVCT's #COVID19 LFT.

By the end of next week, the Co intends to have put out a comprehensive TU.

Critically, it will include the sensitivity / specificity of its #COVID19 LFT for the first time. Analytical data collected so far suggests that it'll...1/14
...be the most accurate LFT in the world. However, it is not a given that analytical data will be replicated in the clinical data. Likely, but not definite.

Let's assume it IS replicated. #AVCT will CE Mark its LFT next month, and immediately begin selling it.

2/14
@avacta #AVCT does not have its own manufacturing capacity (yet). It will be contracting manufacturers to make its test.

It's lined up @Abingdon_Health #ABDX, @bbi_solutions and @mologic / GAD, and is working with @OmegaDiagnostic #ODX too (although not publicly announced). 3/14
Read 14 tweets

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