EuGeni, page-1041

1. If as has been suggested, Respond Global are likely to initially utilise the BioAccess CareStart RAT in it’s Australian rollout, I think that’s not all bad news for the future prospects of the Eugenie package in this country.

Here’s a link to an large independent study of the BioAccess device conducted in the U.S. earlier this year.
https://www.medrxiv.org/content/10.1101/2021.03.07.21253101v1

In my opinion, Anteo’s Doherty trial results; 97.3% sensitivity, 99.6% specificity, and impressive PCR cycle threshold (Ct) data, compare very favourably with the BioAccess trial results.

Subject to TGA, Anteo’s Australian distributor, Adacus dx have a good basis to commence negotiations in my view.

2. I’ve been trying to understand the challenges Anteo face in overseas markets. There’s a total of 92 countries in Europe and Asia. That’s a lot of regulatory red tape to negotiate. I thought I’d look at just one, Germany.

The Paul-Ehrlich Institute (PEI) is an agency of the German Federal Ministry of Health, with similar credibility imo but broader influence than the Doherty Institute here in Australia.

With several other well credentialed European institutions, the PEI periodically conducts a “comparative evaluation of the sensitivities of SARS-Cov-2 antigen rapid tests”, (or POCTs).

The POCTs are evaluated using the same method and sample source, so unlike some other reviews, the results have both independence and comparability. (Note, specificity is not assessed)

Based on these results, the PEI periodically publishes a list of “state of the art” POCTs. The current list, published on July 12^th is in this link.
https://www.pei.de/SharedDocs/Downl...iew-04-12-2020.pdf?__blob=publicationFile&v=3

My understanding is that in order to be tested in this way, a POCT must first be accredited by Germany’s Federal Institute for Drugs and Medical Devices, (BfArM).

However according to the document (which loses a little in translation): “ …. this comparative evaluation can only cover a random sample of the SARS-CoV-2 tests listed by the BfArM, thus eligible for refunding, and that few other products could not (yet) be taken into account, despite the interests on the part of the manufacturers/distributors.”

So while the CE mark was an important step, imo it's doubtful that sales to any German Government agency would occur without first also obtaining BfArM accreditation and positive analysis from the PEI.

If Anteo’s European/Asian reps/distributors are worth their salt, I’d hope they’re fast tracking the paperwork in each jurisdiction and distributing trial cassettes and readers as their first priority.

3. For what it’s worth, if I was an overseas buyer, I’d think twice about purchasing a product that wasn’t approved in its country of origin. So if anything positive could possibly come from this Delta outbreak, fast tracking from the TGA would be a good start.

One man’s opinion.
Herro