Member Info for serendipity

Dug,

Maybe the company are waiting for the results of this study, link below , before joining the National screening trial.. Make no mistake, I’m massively down on this share and would welcome any positive news!

https://research-portal.uea.ac.uk/en/projects/new-epigenetic-markers-for-prostate-cancer-detection-in-black-men

Dog walker

I don’t think the UK screening trial is a dealbreaker personally.. perhaps it’s not a priority for the company, i.e. to provide free PSE tests in a study when they can sell them via BUPA?

Private health care companies will pay for tests if it'll save money on their overall costs (fewer biopsies). Drs will request a PSE if they're allowed to by the health insurers regardless of the cost.

Also I'd pay for a test rather than go through 16 needles into my prostate under local anesthetic!

I think they definitely need the labs to process the tests, you can't sell a test that you can't send to a lab. There is also a UK study due to complete in the next few months testing PSE in black men. I believe that there will be a high demand for the PSE test when the UK lab is approved (? end of March) especially with established BUPA links but that's just my opinion.

I think they seem to specialise in M & A but do your own research.

Does anyone else think the company is a target for takeover by a large pharma like Pfizer ( Viagra) or Lilly ICOS (Cialis)? Especially before the US launch?

It’s a frequent occurrence for clinical trials to open and then have amendments to include other arms of the trial. Just because PSE isn’t in the first version of the protocol doesn’t mean it won’t be included via an amendment when approved by the governance process (REC ethics committee). Just my opinion.

Is there a buyer in the background, sales should equal buys. A dummy sell lets me sell all my holding, something doesn't add up..

bighammer, you're numbers are wrong - I've cut and paste this for you - from placing RNS 10th Sept 2021 FYI
'The Company estimates that the total addressable UK market is up to £5 million per annum with Europe potentially another £30 million per annum. The Directors believe that the UK and Europe presents an attractive market opportunity for the Company to target. The Company expects to pursue a direct distributor model alongside some investment in its own business development activities including a direct selling and support team of less than eight people which will be complimentary to IHC and help drive initial adoption.
In terms of the US opportunity, that market is estimated to have 900 sites and 500,000 infant intensive care admissions per annum and a market opportunity in excess of £20 million per annum.'

Reality is, GDR have stated income from NHS is £5M (company spends are £5.5-6 M p.a). They need to sell to EU (estimated £30M market to generate profit. Also will need to spend an estimated £2 million to get this test through FDA studies to sell into US.
I'm looking forward to hearing what the CEO presentation next week tells us about H2 plans.

Doc. updated today
https://www.genedrive.com/documents/id-rnr1-ifu-en_v10_genedrive_mt-rnr1_id_kit_instructions_for_use.pdf

https://www.genedrive.com/assays/cov19-documentation.php

Inphobe, I agree. We were told in the last GDR presentation that the PALOH study will be published in a prestigious US pediatric journal. A study author said that it is expected to be published in March (they should know). In my opinion this could be released online any day now. Obviously, NICE will need this publication before releasing their guidance.

GDR website update today, Inspiration Health details added on distributor page for the AIHL test. Hopefully this indicates the product launch will happen soon!
https://www.genedrive.com/distribution/index.php

As far as I understand the LAMP tests described here are Lab based tests, which are considerably more expensive to run than the GDR POC LAMP test. The article suggests that NHS trusts will have to pay for COVID testing themselves in future, which I would guess they will (IMO) as part of their infection control procedures.

IMT-RNR1 instructions for use doc. updated today on GDR site
https://www.genedrive.com/assays/mt-rnr1-documentation.php

GDR evaluation study at Ulster University reached it's recruitment target this afternoon. Don't know if this is related to UK CDTA evaluation/approval process but hopefully we'll get good news soon! GLA
https://redcap.science.ulster.ac.uk/redcap/surveys/index.php?s=8DTLDREKKECP77DN

RNS 10th Sept. states:
The Company believes that notwithstanding widely available lab based PCR, the Genedrive® COV19-ID Kit will be well placed to build an attractive market presence across a number of end markets where speed to result and its point of care nature will be key attributes. The Company expects demand will emerge in areas like urgent need to travel, work places with risk of transmission is high (e.g. care homes), elite sports, cruise ships and emergency care. genedrive believes it can achieve a transfer price of £20-30 per test and around £2,000 for the units.

Due to the Uk wide shortage, perhaps BC have sold some PCR lab tests??

Future News Flow
From RNS
'Prior to the end of calendar year 2021 (assuming the Fundraise is completed) the Company is expecting to launch the AIHL assay in the UK across three - five adopter sites, announce clinical test data for the GDR COV POC and attain a CE mark and commence initial sales via partners.'