- Doubles National MonkeyPox testing capacity
Todos Medical Inc. (OTMKTS: TOMDF) announced the validation of its MonkeyPox lesion and saliva-based test. Other than Flow Health in California, no other labs have a saliva-based MonkeyPox test let alone one as sensitive as TOMDF’s. It is a laboratory-developed test (LDT) which means it is commercially available for clinicians to send samples for testing immediately. The company also announced that they are doubling the national testing capacity which according to the CDC is 80,000 tests per week. The 5 labs named by the HHS that make up the lesion testing capacity in the United States are Aegis Science, Sonic Healthcare, Labcorp (NYSE: LH), and Quest Diagnostics (NYSE: DGX). Half of these labs are using the CDC’s assay (NVO Test) whereas TOMDF uses its own LDT. Todos sees its capacity at 175,000 weekly and hopes to beef that up to 350,000 weekly.
On Friday, August 19th Applied DNA Sciences (NASDAQ: APDN) presented NY State Department of Health (NYSDOH) with an LDT validation package for MonkeyPox approval. In the past APDN worked with NYSDOH to get their COVID-19 assay conditional approval. It was widely expected that APDN was going to take a leadership position in MonkeyPox testing targeting the state with the most cases, but this Todos news likely shocked everyone.
Not only does it look like TOMDF is the national leader in MonkeyPox testing, but it looks like they are way ahead of everyone with respect to the saliva testing that can diagnose people asymptomatically if they were exposed. Right now only lesion testing is allowed for diagnosis but the existence of a validated saliva test is sure to attract the attention of the CDC and lead to approval none of the big labs would initially have access to the test and this would put TOMDF’s lab in a very good strategic position. In fact, it would be some time for the big labs to do saliva because their current lesion approval is via the 510(k) pathway and they are stuck using the CDC NVO test kit and their reagents may not be good enough to pick up a signal in saliva. Labs like DGX and LH cannot do LDT tests like Todos Medical because they have multiple sites making them ineligible for the CLIA lab workaround.
Unmatched Sensitivity in Saliva-Based Test
The testing sensitivity revealed today demonstrates that TOMDF has superior reagents. Their LDT requires only 1.2 viral copies per reaction for validation. Their test is extremely sensitive and only a small amount of viral load in the saliva will be needed to identify an asymptomatic person. Additionally, the company announced that it has all the protocols associated with a BSL3 lab required by the CDC for MonkeyPox testing. Their supplier also has the capacity to deliver over 1.0 million PCR assays weekly. This enables TOMDF’s subsidiary Corona Diagnostics, their distribution arm, the ability to supply other labs with the necessary reagents to quickly expand testing capabilities. While 1.0 million PCR tests sounds like a lot TOMDF has the foresight to
“assist them with assay validation in the event there is a need for testing beyond Provista’s capabilities. The availability of this increased testing capacity and materials supply to aid in the US MonkeyPox public health emergency mitigation efforts, coupled with saliva testing for mildly symptomatic and asymptomatic individuals, will provide the opportunity to dramatically accelerate contact tracing efforts by serially testing of exposed individuals in order to give greater certainty to the individual that they are not infected or contagious, and provide the needed better opportunities to break the chains of infection.”
Lesion Testing Flawed Approach
Right now there are shortages of getting lesion testing done for MonkeyPox because until recently it was restricted to CDC laboratories not capable of the testing loads. In a John Hopkins interview, Amesh Adaja said
“We need to think about can we do saliva testing? Can we do other ways of testing for this so that people can know their status earlier? There’s some technological hurdles there, but just like it was with COVID-19, becoming a major barrier to getting a handle on an outbreak.”
This highlights the need to move immediately to saliva testing and Todos has a validated test and the capacity to do widespread testing. Only the will of the CDC and sound pandemic policy is in the way.
Todos Medical is essentially the leader in the MonkeyPox testing space and has demonstrated its ability to outthink the CDC and key opinion leaders in the space. They have a highly sensitive saliva-based MonkeyPox test and are responsible for over half the national capacity for MonkeyPox testing. MonkeyPox numbers have been underreported but as more testing comes online the case count is going to look exponential and in turn drive more testing business and TOMDF with its capacity sitting there is surely going to get used as the administration scrambles to find a solution that all say it requires more testing and earlier testing. For a MonkeyPox play, TOMDF is the best in the show and extremely undervalued with a $35 million market cap if they were just a MonkeyPox play. APDN has a $50 million market cap and they don’t even have a commercial test approved yet. A major Catalyst will be when the CDC moves to Saliva based testing and TOMDF is the only company with capacity.
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