Following First FDA Approval for MDx Platform, iCubate Has Eye on Point-of-Care Market

August 30, 2017 – NEW YORK (GenomeWeb) – Having recently secured US Food and Drug Administration approval for its molecular testing platform and first test, the iC-GPC assay for gram-positive bacteria associated with bloodstream infections and antibiotic resistance markers, iCubate is already planning its next commercial assay.

The Huntsville, Alabama-based spinout of the HudsonAlpha Institute of Biotechnology plans to tailor its next bloodstream infection product to a gram-negative bacteria detection and drug resistant genes, and believes this assay will be even more extensive than the gram-positive assay.

Company founder and CSO Jian Han envisions a future where point-of-care testing using their upcoming devices will become the new clinical standard, allowing patients to self-diagnose common diseases in local pharmacies or store-corner drugstores. According to one beta tester, it has the potential to change point-of-care testing, but the proposed technology is still at least few years off before clinicians will actually be able to implement it

After solidifying its grasp of the bloodstream infection (BSI) technology market, iCubate sees the field of infectious diseases, especially drug-resistant pathogens, as an immediate market need that it will tackle with future products.

“We talk about precision medicine, and it seems like precision medicine is associated with oncology; actually, infectious disease needs precision medicine badly,” added Han.

Bloodstream infections and eventual sepsis occurs in the US at around 300 cases per 100,000 people per year. Sepsis and other complications that stem from BSIs are now the 10th leading cause of death in the country. In order to save money, time, and human lives, iCubate developed a clinical tool that will speed up diagnosis of pathogenic bacteria and allow doctors to more accurately provide antibiotics.

Running on the iC-System, the iC-GPC assay leverages iCubate’s amplicon-rescued multiplex PCR (ARM-PCR) technology, developed by Han. According to Han, ARM-PCR distinguishes itself from other molecular approaches in that it allows for the detection of multiple targets in a single, closed reaction.

During the test, a clinician takes 10 microliters of a blood culture sample and  loads it into the iC-GPC cassette. He then insert the cassette into the reader and run the assay. According to a video on iCubate’s site, the instrument then performs a PCR amplification, hybridization, and readout.

Similar to Luminex and Nanosphere, iCubate uses a hybridization approach to detect amplification products rather than real-time PCR technology. Each instrument can handle up to four cassettes in a random-access fashion.

iCubate CEO Carter Wells described how testing a patient’s blood samples with the iC-GPC assay produces results in three to four hours, compared to standard microbiological methods such as blood culture that require two to four days to generate bacterial identification and antimicrobial susceptibility test results.

The iC-GPC system identifies S. aureusS. epidermidisStreptococcus  pneumoniaeEnterococcus faecalisE. faecium, in addition to detecting key resistance markers specific to vancomycin-resistant Enterococcus and methicillin-resistant Staphylococcus.

iCubate projects its target market for the iC-GPC to be small and mid-sized community hospitals and clinics. Once the iC-GPC assay is up and running, iCubate plans to collaborate with application developers to create “apps” that customers can use in order to self diagnose common infectious diseases such as influenza and the common cold. Han envisions these devices popping up in pharmacies such as Walgreens, Target, Wal-Mart, and smaller clinics that don’t require sophisticated lab personnel.

“It’s a catch 22: you need more platforms to be out there allow other people to get interested, to develop more apps, but the more apps will push the platform to a higher level, so we’re working with app developers, small and large companies alike, freelancers,” Han said.

Han likens the company’s technology to a iPhone developer kit. Developers have high-level software on the iC-GPC system that they are allowed use to program their own unique apps. While there’s a default set of apps pre-installed, developers can make an app they see a potential market for, inspiring innovation.

Each one of iCubate’s cassettes has a unique 2D barcode, which the system and reader scan the barcode so that the patient’s info is linked to the sample. The barcode also contains business model information, detailing the background of the developers who made the assay, which market the assay is specific to, and the proper way to run the assay to record the result.

Because iCubate prints the unique barcode for each of its device’s cassettes, it can open the platform to other assay developers and protect them, their IP, content, and even its own technology. The company can therefore sell developer-unique barcodes to third-party companies to run on iCubate devices without fear of losing its own intellectual property.

While iCubate currently cannot disclose the price of its platform or iC-GPC assay, Han said it has sold more than 20 machines to laboratories for research purposes.

The Laboratory Alliance of Central New York (LACNY) has been using iCubate’s iC-GPC assay and platform since its early development three years ago. LACNY focuses on detecting gram-positive bacterial organisms in the blood, primarily S. aureus, in addition to lesser pathogenic staphylococcus referred to as coagulase-negative S epidermidis.

Paul Granato, director of microbiology at LACNY and a member of iCubate’s scientific advisory board, explained that the organization was originally involved with iCubate as a beta site, “working out the kinks of the assay for iCubate as they were working on their gram positive panel.”

During development, Granato’s team was invited to participate in the generation of data that would eventually result in iCubate receiving clearance from the FDA for the iC-GPC assay and platform.

Granato’s team has been testing the assay for the early detection and identification of methicillin-resistant bacteria. If the assay identifies resistance gene markers, LACNY can instead prescribe patients vancomycin, one of the few therapeutic options resistant to staph bacteria. Due to its potentially deleterious side effects, however, the reserve drug is typically only used when it’s specifically indicated for methicillin-resistant organisms.

“The assay not only provides for a reasonably rapid identification, once the blood culture has detected as positive, but at the same time it will provide an indicator as to whether it carries resistance markers, so that clinicians are able to make informed, therapeutic choices as to figure out which antibiotics are effective,” Granato added.

Granato and his team are now in the process of developing beta site testing for iCubate’s gram-negative panel, which will detect the common gram-negative organisms responsible for septicemia or bacteremia, as well as detecting the presence of key resistance markers that these gram negative bacteria might harbor.

Regarding Han’s vision of the iCubate technology eventually finding its way into pharmacies and other point-of-care settings, Granato noted that iCubate “would have a greatly simplified assay, low complexity, which means it can be performed anywhere to determine as to what a patient might have.”

Granato believes that the future device might not evaluate septicemia, but could help diagnose if a patient has a localized, common infection that is not life threatening but needs to be evaluated, like influenza or strep throat.

“I think that’s the eventual goal, and obviously that’s not going to happen this year, not likely to happen next year, but it’s in the future plans as this technology becomes more robust, in terms of to offer a broader menu of molecular targets you can screen for,” he added.

Since its inception, iCubate has been mostly angel funded by investors in the southeast US. Moving forward, the company will look toward identifying and securing additional funding from that region. iCubate currently generates revenues by working with assay marketing partners, including iRepertoire, a startup founded by Han in 2009.

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