For any newbies reading through these threads, it can be difficult to discern facts from assumptions and hypotheticals in relation to NanoDiagnostics and their NanoDX POC system (previously known as BioDirection and the Tbit System).
Perhaps a couple of quotes from our own company in recent announcements helps, given ASIC disclosure requirements would infer these can be read as gospel, and helps make sense of what is being said by contributors. I have highlighted key passages which reference recent contributions :
Jan 21 Quarterly
The customer for the SARS-CoV-2 detection sensor which has been discussed by the Companypreviously can now be disclosed as NanoDiagnostics Incorporated (NanoDX). The two companieshave been in partnership for more than eighteen months having initially collaborated on aTraumatic Brain Injury (TBI) sensor using a patented nanosensor technology platform to detect thepresence of biomarker proteins in the blood. This was awarded a breakthrough devices designationby the Food and Drug Administration (FDA) and is the same platform and sensor used for the SARSCoV-2 solution.
The Emergency Use Authorization (EUA) submission to the FDA was delayed due to some issues inthe final cartridge assembly. These issues are being addressed and submission will occur onceNanoDX is fully satisfied with the end product. There is a risk that NanoDX may not satisfy the FDA’srequirements for an EUA and/or the evaluation of NanoDX’s EUA submission may take longer thanexpected. Sensera has secured a manufacturing agreement predicated on FDA approval, which willbe fully disclosed in the event that NanoDX receives the approval.
Mar 21 Half Yearly Accounts
The SARS-CoV-2 sensor developed in conjunction with NanoDx has progressed through theR&D phase and the final product is now in the hands of NanoDx. The Group has engaged in a material agreement that willbe fully disclosed once the sensor reaches FDA approval.
Apr 21 Quarterly
NanoDiagnostics Incorporated (NanoDX) has continued to have challenges with releasing theirSARS-CoV-2 detection system. This has slowed progress towards volume production.Notwithstanding, Sensera has been asked to start the ramp of sensors in Q1 of FY22. This ramp isstill predicated on FDA approval through the Emergency Use Authorization (EUA) process. Aspreviously disclosed, there is a risk that NanoDX may not satisfy the FDA’s requirements for an EUAand/or the evaluation of NanoDX’s EUA submission may take longer than expected.
To me, this commentary from Sensera, who need to be very careful with what they announce, ties in nicely to what we are hearing (albeit unofficial) from Stewart Mackie and representatives of both NaoDiagnostics and Turning Point Diagnostics. The continued challenges referenced in the April quarterly, which most, including myself, read as bad news ( continuing cartridge issues? ) may in fact have been good news! It seems NanoDX were modifying their system to detect all variants of Covid19 before seeking final approval and release to the market , which has to be a very positive sign.
So, IMO, everything is lining up nicely and I expect good news on the NanoDX EUA application soon.
GLTAH
SE1 Price at posting:
6.8¢ Sentiment: Buy Disclosure: Held
