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ODX getting approval for the visitect test so that it is legal to be sold in the UK is "nothing to do with ODX"

That's so reassuring.

No matter how many different people post this, it doesn't change the actual fact that DAM can NOT provide a test that is not legal to be sold in the UK.

Visitect is ce approved for professional use. in the uk.

However AVACTA is saying that "This is a new requirement for the supply of any COVID-19 test in the UK and is OVER AND ABOVE the CE mark"

ODX twitter is normally active in correcting misconceptions, but no sign of a "get yer tesla" clear-up tweet.

Swag:-

According to the AVACTA RNS

"The new CTDA Regulations stipulate that all suppliers of COVID-19 tests must submit information regarding their products for desktop review if they wish to remain on sale in the UK."

Suppliers in this context means ODX, hardly suggests that every outlet has to submit. We *assume* ODX has submitted, but it's not on the list of ones that have been accepted. It's also not on the PD list, which also allows acceptance.

"On sale in the uk ", does not imply or infer sale to individuals, it can not be sold at all in the UK to anyone, for any use.

"Exactly. You have to differentiate the role of the supplier & distributor. Where & how they sell is entirely upto them."

As is when they re-order. They'll only reorder when they use what they have and the vast majority of their clinics are in the UK. One assumes that they aren't stupid enough to get themselves into a position of not being able to do a single LFT test in the UK tied to a test that's illegal to use, so they'll of course have a backlog of other tests still to use and likely the terms of the agreement are such that the exclusivity only kicks in when visitect can legally be sold in the uk.

oke, I am talking about uk sales for DAM, which is clearly their major market given their list of test centres.
https://www.dam-health.com/

'business as usual' process.

Which in ODX speak means, waiting for ANOTHER approval.

FDA approval, EU self test approval, UK approval for visitect, yeah that just all "business as usual" and no need to inform shareholders about any of that.

it does not say when the deal starts....which was my question. If it is already in place, DAM can not supply an lft in the uk, as the one that they are restricted to (visitect) is can not legally be sold.

They may not be "required" to inform their shareholders about getting approval, but to put on their first RNS all year relating to a sales deal that mentions the uk market, but not inform their shareholders that the test in question can not actually be sold in the uk market, is appalling investor communications, and quite disingenuous.

I wonder when the exclusive part kicks in for DAM. If it is already in place, then they can't provide any LFT testing in the uk ?

"Also, trolls keep telling us ODX aren’t currently selling any tests in the U.K."

Unless you are calling AVACTA a troll, you'll find it is them that just clarified that ODX can't sell its visitect test in the uk.

DAM can provide tests, whether they can provide the visitect test is determine by whether the viitect test has passed the desktop review. Given the AVACTA RNS this morning, there are only 3 that have done so. These along with those that have passed the previous PD testing can be sold in the uk from nov 1st. visitect is on neither list.

One assumes visitect is one of the 48 tests that AVACTA says are waiting approval.

ODX continues to be so poor in keeping their shareholders up to date with regulatory issues, that we are getting our info from RNSs of other companies.

greg22, the list is for those tests that can legally be sold in the uk since 1st Nov, Nothing to do with fit-to-fly retailer list. Until/Unless ODX can legally be sold in the uk, it'll not be on ANY list !

inhouse broker still talking about Covid-19 providing "potential" upside in Nov 2021 is very telling.

so does that mean that at this time DAM can't use a single ODX test in the uk ?

Have ODX applied and paid the appropriate £89K/£35K fee
https://www.gov.uk/government/consultations/validation-of-covid-19-tests-laboratory-validation/validation-of-covid-19-tests-laboratory-validation

I agree, the test has been validated in lab and in studies, but the real validation is when someone signs up to buy it. Don't have a baldy notion who DAM are, but one assumes they have the wherewithall to pick a decent test.

A bit clearer now why ODX mentioned the DHSC contract on twitter. The deal does mean that DAM is the only company that ODX can supply the professional visitect test to in UK and Europe. ODX wanted to make clear that the exclusivity doesn't affect any deal with the DHSC, which *might* also be for the visitect test, but which is for home use.

DAM's current usage of 200K a month seems really rather small compared to the Total Addressable Market of all of the EU and UK for a professional LFT test, for them to have gotten exclusive use...equates to approx 2.5% of ODX's capacity.

A second firm deal of any sort in quick succession would start it motoring.

Pretty clear that DAM will only use visitiect test for their professional needs going forward, i.e. will not use any other test.

"TW,
Suggest Colin was indicating - via social media - that this was not going to affect their capacity for the DHSC."

That's a possible explanation for the tweet, perhaps reassurance that this does not imply or suggest the DHSC deal is gone.