A Platform Approach: Expanding a Molecular Diagnostic Device Beyond Human Applications | By Shaun Holt, CEO, Alveo Technologies

Summation

  • Most LAMP-based tests use an optical means of detecting the presence of specific virus, bacteria or fungus, but this method is susceptible to failure if the test is jostled – a likely event on the farm at pen-side.
  • The more the virus spreads, the higher the chance of a mutation that will lay the groundwork for a pandemic that could be far worse than the one caused by SARS-CoV-2.
  • And, as noted above, each infected chicken, duck, or turkey is a bioreactor churning out millions of new viruses, one of which could be the one to spark a deadly human outbreak.

Avian flu is a global crisis, and not just for the poultry industry. There are serious potential implications for human health as well. But, let’s start with agriculture. Some strains of avian flu can be highly pathogenic. Once a single bird shows symptoms the clock starts ticking — it’s not unusual for an entire flock of tens of thousands of birds to die within two to three days.

Bird flu is also endemic. In 2005, H5N1 spread from poultry to migratory birds, which has resulted in its rapid, global spread. And the damage to the poultry industry has been severe. In 2015, 50 million chickens and turkeys were slaughtered on 200 U.S. farms in 15 states, causing $4 billion in losses. It’s the most expensive animal health disaster in US history.  In 2022 in France, a similar outbreak resulted in $1.2B in losses. Almost needless to say, the virus has significantly disrupted the global trade in poultry products, negatively impacted food supply, and in most regions of the globe, increased prices for meat and eggs.

Even more distressing, the risks of adoption and spillover to humans is high, with the probability increasing as a function of time. Many strains of avian flu pose the risk of mutating to enable efficient human-to-human transmission, but H5N1 is of particular concern. Granted, H5N1 does not spread efficiently from human-to-human today, and the number of documented cases has been small: just 240 since 2003 — but 53% of those known to have contracted H5N1 have died, a terrifyingly high mortality rate.

Virologists have already identified the specific changes in the genome that would allow it to spread easily between people, and people are in constant contact with poultry, potentially putting them at risk of infection. Additionally, the virus has not only spread to birds, but also to dozens of mammalian species, including mink, seals, foxes, dogs, and cats. The more the virus spreads, the higher the chance of a mutation that will lay the groundwork for a pandemic that could be far worse than the one caused by SARS-CoV-2.

 Controlling H5N1

The first step is to test and track infection. Farmers need rapid diagnosis to act quickly. The faster the infection is detected, the faster farmers can take action to mitigate the damage. And, as noted above, each infected chicken, duck, or turkey is a bioreactor churning out millions of new viruses, one of which could be the one to spark a deadly human outbreak. The longer these “bioreactors” operate, the higher the risk for everyone.

Governments also need data to understand the spread. Data collection for avian influenza is haphazard and decentralized, which makes tracking the spread difficult. Currently, testing typically takes one of two forms: PCR and antigen. PCR tests are very accurate, but they require sending samples to central or nationally approved laboratories for testing. Results can take days, even weeks to process, depending on lab capacity, which delays decision-making at the farm level, increases the risk of infection from one flock to another, and extends human exposure time.

Antigen tests, on the other hand, provide fast results and the test can be performed on-site. But these tests are significantly less sensitive than molecular based approaches, returning a significant number of false negative results, which also enables the virus to spread unimpeded and delays action that could stop or slow its spread.  A paradigm shift is needed, with fast, portable, and accurate molecular testing at the point of need providing the ultimate solution.

A LAMP Technology Platform Approach

Alveo Technologies was founded to develop on-site, rapid and accurate molecular diagnostic tests for human infectious diseases, such as COVID-19 and influenza. To this end, the company developed a ruggedized device that employs LAMP technology. LAMP stands for loop‐mediated isothermal amplification, which is an amplification method that does not require thermal cycling – heating up and cooling down the sample – like that of PCR.

Most LAMP-based tests use an optical means of detecting the presence of specific virus, bacteria or fungus, but this method is susceptible to failure if the test is jostled – a likely event on the farm at pen-side. Alveo, on the other hand, uses electrical methods of detection, not the more common optical turbidity or flourescence approach, which increases the ruggedness of the design. As a result, the Alveo platform provides precise, fast results in the field, with results in minutes. One can literally drop the test to the floor, and it will still process the sample.

Additionally, the device is connected wirelessly to the Internet, so that results (which are timestamped, geolocated, and ID’d for the end user) can be uploaded instantly to the cloud. This capability provides organizations and government authorities with rich, recent data, across all relevant testing paramaters, that they can use to track and model the spread of the virus in a decentralized and efficient way.

Currently, the Alveo be.well COVID-19 Test has CE Mark, which means it is available in the EU, Middle East and the Caribbean. The platform, however, isn’t limited to the detection of human pathogens. With different primers, the platform can detect essentially any biologic. The test detects specific genetic sequences – it doesn’t care what the DNA or RNA’s provenance is.

Alveo’s management saw an opportunity to help address a massive agricultural problem and potentially prevent a deadly pandemic. As such, Alveo is partnering with veterinary and agricultural companies to develop tests for bird flu that will provide rapid results in the field and also create a constantly updated rich dataset for use in studying the virus’ growth and migration. And the possibilities don’t stop there. Alveo’s platform can be applied to the detection of crop diseases, water borne pathogens, fungi, and so on – if a disease is caused by a pathogen that contains DNA, with the right primers, Alveo’s platform can detect it.

It’s a lesson for medical device companies of all kinds. These devices may advance the practice of human medicine, but approvals for human use cases take a significant amount of time to achieve. There are many cases where medical devices and tests may have applications for agriculture, farm animals, or companion pets, where approval timelines are shorter – but the impact to society is just as great. Partnering with organizations that have agricultural expertise can expand the revenue potential for a product and also provide value to customers beyond the traditional medical field.

In Alveo’s case, H5N1 bird flu poses a serious threat to agriculture and potentially human health. By partnering with experts in the poultry industry, Alveo’s platform can be applied to help contain the agricultural damage and protect our food supply, and potentially prevent another, possibly more deadly pandemic.

 

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