I just re-read the letter to shareholders again from the quarterly, I think we might be in for s pleasant surprise:
"Our saliva test development work continues as a highest priority focus. We continue to be encouraged by the results we are seeing, which is helping to refine our lysis buffer formulation. We are confident that saliva will be one of the sample types that can be utilised within our COVID-19 ART ." Remember this paragraph, it's important.
"We were recently awarded an up to $1.4 million grant from the QLD State Government, allowing us to solidify our market differentiation and set a course toward increasing revenues. The grant has also enabled us to accelerate elements of the program to address the challenges that have arisen during development. These challenges include:- Low COVID-19 case numbers in Australia have made access to validated positive COVID-19 patients for the purposes of a prospective clinical trial more challenging. In response, we have pursued clinical trial activities in association with VIDRL using stored patient samples. These samples are stored in dilution using Viral Transfer Media (VTM), which can cause signal interference with the test. The VTM cannot be removed in this clinical trial setting and is not present in the normal intended use of the test. i.e. direct patient sampling. For those who doesn't know, this is what VTM looks like:
- Our saliva development work continues to encourage us, and we believe that a saliva use case for our COVID-19 ART and COVID-19/Influenza A/B multiplex test will set a market differentiating position that few will be able to emulate. However, in the world of stored samples for clinical trials, COVID-19 positive saliva samples are extremely rare, and this is now hampering our development for regulatory approval for a saliva use case for testing. From my understanding, any lab or POC Covid test involves a swab up the nose, therefore, no one would really store saliva samples from a Covid positive patient, which makes it harder for ADO to test and fine-tune our saliva test.
- There is a requirement for AnteoTech to conduct direct patient prospective clinical trials, often after emergency use approval is received, to satisfy regulatory requirements. These trials are a definitive assessment of the test's performance as the trials use in situ positive afflicted patient samples to test samples free of any VTM elements. Seems like even after EUA approval, we'd still have to go through "direct patient prospective clinical trials" - proof how effectively/accurate the test is "in situ", free of any interference from those VTM, as the sample will be collected directly from the patient's nose/saliva and straight onto the test strip.
In the light of these challenges we have decided to accelerate our planned patient prospective clinical trials by six months and to initiate processes to begin these trials before initial market entry. We are currently finalising an agreement to conduct a prospective clinical trial in India, where the prevalence of SARS-CoV-2 positive patients is much greater than in Australia. This trial will be completed via our partner organisation Novatech and will include a full evaluation of the COVID-19 ART using VTM free nasal samples as well as saliva samples direct from patients." IMO, this bit is actually huge. In the past, we were told that swab Covid ART will come first, then saliva Covid ART will come later or there was a slight chance that it will be included in the initial product launch. But after re-reading these few paragraphs, I'm led to believe that there's a much higher chance "saliva will be one of the sample types" on our initial launch, here's why:
- As DT said, "saliva test development work continues as a highest priority focus"
- As the company understands that the Covid ART field is getting more and more saturated, "saliva use case for our Covid ART and Covid/Flu A/B multiplex test will set a market differentiating position that few will be able to emulate". I understand that there's a rush to get the product out, but if opportunities arises, why not do it once, do it right and claim the bigger marketshare straight off the bat?
- Annnnd, here's the opportunity. Due to the fact that, A) Covid samples in VTM will cause interference with results, B) there's not enough saliva samples in VTM/storage. ADO decides to take the slightly longer (but needed to be done anyway - planned for 6 months later) route to kill 3 birds with 1 stone, to do the required 'prospective clinical trial in India. Which A) will showcase how good our test is in situ, B) Covid positive saliva will be in abundance over there, C) since we have the extra QLD Gov fund and our own small manufacturing capacity in Eight Mile Plains, we might as well do the trial now, especially if it can help proof the sensitivity in our test and enable us to include saliva as a sample type.
I must admit, when I first read this, it sounded pretty negative, but upon another read, I think this is actually the right thing to do. Rather than rushing a normal Covid test out there with sensitivity numbers hampered by VTMs, we take a slight delay and get the launch product's specs right WITH saliva as a sample type.
