Member Info for tecbadger

In this particular industry you don't tend to give up exclusivity without the distributor agreeing to minimum orders be that per month, fq, or year. Hopefully this is the case here. Nice shot to the arm either way.

Those testing numbers really drive home that the positives reported in the UK are likely inflated versus other European countries because of higher sampling.

1 day Rodney has nailed it. The scientific community has known about the variant for a long time and traditional testing methods are fine for certain patients where time is not so critical (cystic fibrosis being one)

The clinical utility of the genedrive test is tha Ltd it csn lroduce a result in a timeframe that can allow rapid treatment decisions in sick children

26May2022 has been set in stone as the IVDR go live date for many years. I wouldnt bank on it occurring though as there is a proposal to delay implementation for 3 to 5 years (for current on market products certified under IVDD) as labs and manufacturers are not ready to implement the change.

For example currently around 8 percent of IVD products require review by a notified body before they csn be placed to market with the rest allowing self certification for CE marking.

Under IVDR the estimate is 80 to 90 percent of products requiring this. As a high risk medical device you can guarantee COVID tests wpuld sit in this bracket.

In summary you don't want IVDR yet as it will likely kill or greatly hamper smaller companies who aren't as regulatory experienced.

I'll give it a watch BoJo. I actually work in the field so am fully aware of the value of liquid biopsy and this form of testing is going to grow pretty fast on the next 10 years especially as the downstream technologies for genetic testing are becoming a lot more sensitive.

Hi all

Fairly new to the board but apologies if this has already been shared but here is a link to the journal I found where they used Parsotix to capture CTCs to investigate the EGFR gene within metastatic Non Small Cell Lung Cancer. Reading this introduced me to the company I wish i heard of them a few months ago.

A decent read if your scientifically minded too

https://www.mdpi.com/2072-6694/13/11/2736

Computer909 almost noone can compete in India. There's even a letter floating around somewhere where a load of clinicians found out the COGS for a Cepheid test and used it to put pressure on them to discount even further. It also takes about a year to register a product there. Nightmare

Usually I am asking for help with dealing with the FDA not the other way around!

Maximising I wasn't aware you were the policeman of this board and since we're all anonymous here I don't really have another way of communicating with Regulator who I thought would be interested in another UK company In our industry.

I dont think I've even seen you comment here before so please kindly jog the f*ck on

What do you make of Angle? Proprietary method of capturing circulating tumour cells for liquid biopsy cancer testing.

Appreciate the responses and I have bought in now. Metastatic breast cancer testing has the highest expected CAGR for liquid biopsy testing over the next 10 years therefore the positioning there is excellent.

Good luck all

Don't mention a Tesla!

Came across this company on a research journal and the method of circulating tumour cell capture seems great. What does the board feel is the likelihood of getting regulatory clearance for the product to be used in diagnostic pathways with genetic testing and ultimately prescription of drugs in personalised healthcare pathways?

This morning I had a bacon sandwich and a big mug of tea

You know what to do

There is a proposal to pushback implementation of the new IVD regulation by a number of years depending upon the criticality of the device. SARS-COV-2 tests will be class D devices meaning highest risk and the proposal for these is to pushback to 2025 (from 26May22)

This will be great news for smaller manufacturers lime omega as it means they will still be able to sell product without conforming to all the extra processes needed to be IVDR compliant.

It's great news for healthcare in general as a lot of on market products were at risk of going off market. The new regulation requires 100 percent of product to be reviewed by a notified body before ce marking compared to roughly 8 percent currently. There's only 6 notified bodies currently for 1000s of products.

There may be something in October, there may not. Nobody knows but I certainly don't allow the Eeyore crew represented here by Gary to influence one jot ;)

Tbh this board is now 90% entertainment 10% investment for me

A fair point handome. All of the notified bodies are currently unbelievably snowed under with work to support implementation of the new IVD regulations still due to go live on 22 May 2022

For those not Informed about this the IVDR means that there is no more self certification for CE mark, a notified body must conduct a technical review of every single product and approve before CE marking.

Crucially this means every company must resubmit and get third party approval for every single IVD product currently on market as well as new products if they wish to sell more batches that are manufactured after 22 May 2022. There are also not enough notified bodies currently.

Expect long lead times for IVD approvals

Think he's had a wee dram benny