Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
The LFT to market must be very urgent. All of the technical documentation and product paperwork and packaging, cartons, instructions for use will need to show the Mologic name and address, then be changed to Avacta when they are ready. A lot to do for a couple of weeks.
The difference between Mologic and BbI is that Mologic acts as a legal manufacturer in their own right, BBI acts as a subcontractor and their scope of ISO certification/ISO audit would be focussed differently.
Mologic, as a legal manufacturer, would have good practices for development and manufacturing, but also distribution/traceability systems, regulatory systems, customer services and systems for post market surveillance (the additional obligations of a legal manufacturer which Avacta is also putting in place or subcontracting)
BBI, as a subcontract manufacturer, would be expected to show that they have good practices for development and manufacturing but usually no further responsibilities.
I am not sure about the terminology, but I believe BBi and. Abingdon Health are under manufacturing contracts/agreements. Mologic and Avacta have a commercialisation agreement.
More detail on testing on TV now and also reported in Welsh newspapers
- The Welsh Government has said that the support available to workplaces in Wales to introduce a testing scheme includes the provision of rapid lateral flow devices, training, access to an online testing portal and clinical standard operating procedures and guidelines.
Good stuff
After the Huff post I thought that I would check out Medusa19 to see if there was any other signs of preparation, but no just the minor tweaks and clarification regarding saliva etc. Then I thought about the way Huff had said about returning business and leisure venues and thought I would check out SaturnPass. I may have missed this if picked up earlier, but website being updated for personal/business accounts etc. Looks interesting. No app yet that I could find...
Surescreen is not on there. I cannot see them
Looks like they have written up the test information for all eventualities
- The tests are voluntary and detect the presence or absence of coronavirus by applying a swab or saliva sample to the device’s absorbent pad.
If NHS is posting out tests in their own name and providing the user information, the test is not CE marked.
As a distributor of medical devices, Medusa19 would need to have ISO13485 certification or equivalent justification.
As a legal manufacturer of medical devices Avacta would be expected to show that they are using suitable/certified developers, manufacturers and distributors for their products - all of this would need to be in place for them to justify their ISO 13485 certification.
Cytiva, BBI, Abingdon health all have ÎSO13485. Medusa19 now have it, hopefully showing that they have systems for full traceability to consumers.
Mologic has ISO13485, and that means that they have justification and control over their global distribution partners., which Avacta can piggyback off.
Mologic also has MDSAP which over and above ISO13485 systems, also certifies that they have regulatory systems suitable for USA, Canada, Brazil, Australia and Japan.
Interesting.
@jdt1990 who found this update - https://www.gov.uk/guidance/lateral-flow-validation-prioritisation-criteria-for-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens
They would not have updated the guidance today if they were happy with current performance. This is a small order to keep them going.
Sorry oropharyngeal sample is third on the list.
Just checked the Surescreen website and info on the test - nasopharyngeal or oropharyngeal sample
This is still just a fill-in. It does not meet the government requirements.
Do we know what the Surescreen antigen test uses? Do we know where it came from or when it went through validation with PHE to get government approval?
I think that while BBI have ISO 13485 it is not as a legal manufacturer - they have GMP systems to subcontract manufacture but not the regulatory systems which Mologic, with their own products have.
We still need to CE mark until we determine a Uk equivalent replacement. Although under current regs the manufacturer can self declare to CE mark for professional use. ISO 13485 certification provides the assurance that manufacturing and administrative requirements are in place.
I believe we were hoping for 300 picograms or better. This is very very good.
Joining a number of well known names in ivd/ biotech industries - Julian Baines, Ron Long and Per Mattsson. Very impressive friends and contacts.
Boris - loads of Lfd stocks but hope to manufacture in the UK soon
Welcome to the world of OEM and OBL
OEM - original equipment manufacturer
OBL - own brand labeller
The device is made in China by the OEM who will develop and manufacture under ISO 13485 standard for medical devices, They will provide their technical documentation for the OBL to label in their name and distribute in their territory. The OBL will have suitable systems ISO 13485 to act as a legal manufacturer, registered with the fda/UKMHRA, market surveillance/vigilance reporting/ customer services.
The Innova product as a US company shows both OBL and OEM addresses.
In Europe the EU competent authorities only like to see a single manufacturer named, so the OBL Innova name (legal/virtual manufacturer) would be the only name shown.
I think the British antibody and antigen tests which have been launched recently, aside from ODX UkRTC, but including Medusa 19 saliva protein tests are OBL
We will be paying LSTM for our clinical validation data for our claims support. Condor/Falcon is the approval system for PHE/government endorsement of use.
@Timster - GxP is the terminology used to describe Good Practice in line with regulatory requirements
GMP - good manufacturing practice
GLP - good laboratory practice
GCP - good clinical practice
GDP - good distribution practice
etc etc