The company's infectious disease panels can simultaneously detect multiple different viral pathogens at a low cost, with the ability to easily scale up to 100 microreactors to find subtypes of certain diseases.
Founded in 2014, the Alameda, California-based firm plans to combine isothermal amplification with electrochemical detection, to quickly and cheaply identify infectious diseases from patient samples using technology developed by Alveo CEO and Founder Ron Chiarello and Cofounder Larry Blatt. Blatt's previous company Alios BioPharma developed drugs that targeted human respiratory syncytial virus (RSV) before the company was acquired by Johnson & Johnson for $1.75 billion. The pair began to to develop dedicated tests to detect viral nucleic acid biomarkers and recruited Michael Aicher as Alveo Cofounder and President to help commercialize their technology.
Alveo's platform includes microchips with different infectious disease panels that can run simultaneously on its smartphone-sized device. The firm's chips integrate sample prep, isothermal amplification of genetic material, and real-time detection into single microfluidic channels.
The company's tests target viral and bacterial genetic material using a fixed temperature amplification process in plasma, mucous, or whole blood samples, followed by electrochemical detection of the amplified DNA. According to Chiarello, the combination of isothermal amplification, a simplified electrical detection scheme, and microfluidics allows ease of use and lower costs.
"We can have many of these microreactors on a single chip, and are currently building chips with 10 microreactors," Chiarello explained. "But we can scale up to 100 conveniently, allowing us the flexibility to test for multiple subtypes of a given pathogen or target, combine multiple panels, increase redundancy, or detect more viruses or bacteria simultaneously."
Alveo is currently developing three panels for detecting viruses and one panel for bacterial infections. The first viral panel, made for chronic viruses, tests for HIV, hepatitis A-C, and parvovirus. The second panel, which will detect viruses commonly found in mosquitos, includes dengue, chikungunya, and the Zika virus. The third panel, focusing on acute respiratory viruses, will detect respiratory syncytial virus, influenza A, and influenza B. Alveo's bacterial panel will detect tuberculosis and potential variants.
"Our current panels are for specific customer requests, with Alveo being formed to address voids they need filled," Aicher explained in an email. "Each individual target is independently designed for the specific pathogen by utilizing a conserved region [of pathogens' DNA] to detect all subtypes."
Depending on the number of bacteria or viral load per sample, Chiarello estimates that Alveo's panels will detect pathogens in five to 10 minutes for someone who is visibly ill. In contrast, the test will require around 20 minutes to determine if a patient does not have the pathogen.
Alveo claims that the panels' sensitivity and specificity are strong and comparable to bulkier PCR-based devices used in hospitals and research facilities, but the company has yet to publish data supporting this.
According to Aicher, the company anticipates different commercial strategies depending on the partners they collaborate with in the next 12 to 18 months. Currently building beta units, the firm plans to have products in the field for research use in the second half of 2018. Aicher believes that units will most likely be placed in facilities that are more point-of-care or point-of-donation, rather than research facilities.
"We have great relationships with the [University of California] system and other universities, but we are pushing more for being closer to our commercial application for beta-use than we are in research applications," he explained.
Hesitating to comment on a price, Aicher said that a number of factors will determine the cost of the overall platform, such as the number of viruses included in the panel. However, he does believe that it will be "significantly less than any device on the market" and estimates the cost for the test will be somewhere "in the single digits optimally," and the "readers themselves will be very inexpensive."
While the company declined to disclose most of the investors who participated in the Series A funding round besides Maxim Merchant Capital, Chiarello said that they included "high network industry insiders and technology experts."
Because of the platform's flexibility and portability, Chiarello envisions that the device will be used in locations where inexpensive, rapid diagnosis is of benefit for infectious disease detection.
"We are motivated to make sure the battery operated device can be used anywhere, especially in developing regions where you have unreliable power," added Chiarello.