Under the Microscope: AmplifiDx

In this series, we explain why we invested in our current portfolio companies. In the process, we hope to highlight the white spaces in women’s health and the life sciences — as well as the people, products, and companies working to fill those gaps. The name “Under the Microscope” refers both to our extensive due diligence process and our investment focus on healthcare and the life sciences.

From January 1, 2020 to March 28, 2020, Google searches for “covid19” increased sharply. The rise of the COVID-19 pandemic brought individuals to Google — as well as to their communities, healthcare providers, and more — to learn what they could both about this novel virus and about ways they could test to see whether they themselves had contracted it. Alongside searches for “covid19”, searches for “PCR test” also rose, increasing over 9000% from January 1, 2020 to a peak in July 2021.

Polymerase chain reaction (PCR) tests have been considered the “gold standard” in testing since the beginning of the pandemic. PCR tests take their name from a laboratory technique that takes a small sample of an individual’s DNA, such as that taken from a nasal swab or saliva sample, and copies it millions or even billions of times. Through this amplification, scientists can generate enough material to study the DNA in detail and check for any abnormalities, like a virus. Since their invention in 1983, PCR tests have been used to detect whether or not individuals have had a range of infectious diseases, including tuberculosis, chlamydia, HIV, and COVID-19, and will show whether or not a person currently has a virus, unlike other tests, like antibody tests, which can tell only whether or not a person has had the virus.

One of the downsides of PCR tests, though, is that clinical laboratory equipment and trained personnel are often needed to process each one. While the biggest labs may be able to automate this procedure, most labs rely on their technicians to extract RNA from and add a mix of chemicals to each nasal or salvia sample, which a machine will then analyze in order to deliver results. Without any hitches, processing a single sample in this way can take about six hours.

Over the course of the pandemic, however, labs have faced delays: both due to the sheer volume of tests that need to be processed and to supply chain issues. A study by the Association for Molecular Pathology (AMP) found that more than 85% of responding clinical labs reported delayed or decreased testing because of supply chain disruptions and the subsequent lack of materials needed for testing, like swabs and reagents (the chemicals and machines used to process the samples) About 20% of total respondents in the study reported that supply chain issues had prevented them from being able to test at all.

Those delays and disruptions negatively impact both the labs processing those tests and the individuals waiting for the results. AMP’s study found that most labs do try to turn results around in under 12 hours: 43% of the laboratories that responded to the survey reported turning around test results within 12–24 hours while 34% reported a turnaround window of 24–48 hours. Otherwise, turnaround times can be as high as a week or two — and, in those cases, overwhelmed labs can face a financial penalty as well. As of January 1, 2021, the Centers for Medicare & Medicaid Services (CMS) cut reimbursement for labs that return results after 48 hours, paying $100 to labs that return results before that window expires but only $75 to labs that exceed that time period. Individuals who are quarantining while waiting for results, meanwhile, risk missed work, lost wages, and time away from their daily lives and loved ones.

AmplifiDx’s point-of-care platform, the DX 1000 System, can help mitigate the flaws of the current testing system by providing results that are both accurate and rapid.

AmplifiDx is developing a low-cost point-of-care (POC) platform, called the DX 1000 System, for rapid detection of infectious diseases, starting with COVID-19. The company’s utilization of target-specific fluorogenic detection. in which the target binds to a fluorescent dye, allows it to deliver results comparable in accuracy to labs’ but in about 60 minutes and at a lower cost than current PCR tests, which can cost between $50 or $200 — or much more.

Amplifi’s DX 1000 System in action. Source: AmplifiDx.

The test is also convenient: a POC system means no lab is required to process the tests. Instead, an individual can simply use a nasal swab, insert the swab into the Amplifi cartridge, seal the cartridge, place the cartridge containing the swab in the Amplifi processing instrument, and wait for the results to come through via a mobile app. This process can be repeated wherever the individual is, such as at work, at home or any other “point of care”. AmplifiDx is already looking not only to submit its COVID-19 assay for Emergency Use Authorization but also to pursue future applications of its DX 1000 system for detecting other infectious diseases.

AmplifiDx’s CEO, Nancy Schoenbrunner. Source: Nancy Schoenbrunner.

We invested in AmplifiDx because we believe the company’s DX 1000 system and testing capabilities offer a solution to a major testing dilemma: in fact, in September 2020, The Wall Street Journal summarized the choice that public health officials were already facing less than one year into the pandemic: should companies offer COVID-19 tests that deliver the most accurate results or rapid results? The relevance of that question still today only illustrates the market need for a system like Amplifi’s. By offering PCR-level accuracy at a decreased cost, AmplifiDx can deliver both an accessible testing option and rapid results to individuals who are seeking resources through their healthcare providers, through their communities, or even through a simple Google search.

At Avestria Ventures, we look for early-stage women’s health and female-led life science companies with products or technologies that improve healthcare quality and/or access, lower costs, induce clinical or behavioral change, are evidence based, have scalable commercialization plans, and have a sustainable competitive advantage. Know one? Contact us via our website, LinkedIn, or Twitter.

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