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Startup Novel Microdevices Developing Rapid Point-of-Care MDx System for STIs

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NEW YORK (GenomeWeb) – Novel Microdevices, a Baltimore, Maryland-based startup, is developing a battery-operated, sample-to-answer instrument called Novel Dx that can perform molecular testing from untreated patient samples in about 20 minutes. The firm's first assay in development is intended for CLIA-waived point-of-care chlamydia and gonorrhea testing.

Novel Microdevices has received support from the Center for Point-of-care Technologies Research for Sexually Transmitted Diseases at Johns Hopkins University and also recently won a Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases.

With an estimated 131 million new cases of Chlamydia trachomatis (CT) and 78 million new cases of Neisseria gonorrhoeae (NG) each year, these infections are the top two most commonly reported bacterial STIs. Timely and accurate CT/NG diagnosis is key to preventing spread of infection, increasing proper antimicrobial use to stem the rise of resistant strains, and also preventing complications in patients such as pelvic inflammatory disease and infertility.

Novel Microdevices was co-founded in 2014 by Andrea Pais and her brother, Rohan Pais, who are both co-inventors of the underlying technology. Andrea Pais did her graduate work in microsystems and lab-on-a-chip devices, while Rohan Pais is a mechanical engineer with expertise in robotics and automation.

"Together, the both of us came up with a novel way of being able to run a very complex assay like a PCR on a lab-on-a-chip type device, and Rohan figured out ways to simplify the instrumentation," Andrea Pais, CEO of the firm, said in an interview.

Cost and complexity of instrumentation are currently bottlenecks for implementing POC devices in CLIA-waived facilities, Pais noted, and the duo has found ways to reduce the costs of the cartridge and make it extremely simple and easy-to-manufacture, she said.

The Novel Dx instrument is portable and battery operated. It takes a disposable test-specific cartridge and performs a sample-to-answer nucleic acid amplification test in under 20 minutes, reporting results back to the user in a clear, easy-to-read format.

"All you have to do is add the raw sample to the cartridge, insert the cartridge into the instrument, and then 20 minutes later it displays a test result," Pais said.

The amplification is specifically loop-mediated amplification technology licensed from Eiken Chemical, which Pais said is probably the chemistry the device will use going forward.

The proprietary technology lies in the sample preparation for a complex matrix, like a vaginal swab, which can contain mucus and proteins that make it hard to break apart quickly to isolate nucleic acids. The Novel Dx instrument contains an actuator that "basically automates complex multi-step assays using a precise sequence which involves just sliding and rotational motion of the cartridge with respect to the actuator," said Pais.

This, in turn, reduces the size and the cost of the instrumentation significantly, which then reduces the cost of goods.

The sample prep takes three-minutes from a completely raw sample, such as a swab or a urine sample containing chlamydia and gonorrhea pathogens, to extracted nucleic acids. Following the LAMP step, the detection can be either colorometric or fluorescence-based.

So far, the Novel Dx test results have been basically equivalent to that of a laboratory test, with more than 95 percent sensitivity and specificity with respect to a gold standard, Pais said.

Pais said the firm has not yet determined the exact pricing for the instrument, but it is expected to be significantly lower cost than other rapid molecular diagnostics instruments currently commercially available and will likely be under $1,000.

By comparison, the in-development Cepheid Omni system was considered to have a cost advantage when it was first described in 2015, with an instrument cost of around $3,000. However, Mesa Biotech's exclusive distributor Sekisui has been offering a promotion in which customers get the handheld instrument dock for free when they buy a certain number of flu test cartridges, which are priced around $30 each, as previously reported.

Although the MDx market is quite crowded, the focus on STIs may also give the firm an advantage over other systems, none of which yet have STI targets. Specifically, although there are multiple CLIA-waived flu molecular tests, there are no CLIA-waived chlamydia and gonorrhea tests on the market currently, Pais said.

However, there are also other POC molecular instruments in development or with a CE mark that run STI tests, according to a report prepared last year for the World Health Organization, including ones from Binx, Bosch, and Abbott's Alere.

Novel Microdevices learned about the JHU center and decided to get in touch with the center's director, Charlotte Gaydos.

"We literally just cold-called her and went to her office, and said we have this novel way of doing a nucleic acid amplification test and we want you to give us some guidance," Pais said.

As an expert in the field, Gaydos immediately pointed out all the key features that are required for the technology and the clinical needs. "That was the inception of how we decided to focus on sexually transmitted infections," Pais said.

The firm is envisioning going through clinical trials for a possible dual 510(k) and CLIA-waiver submission to the US Food and Drug Administration. It will focus on chlamydia and gonorrhea in a single test, but would like to also make panel tests that integrate other commonly reported organisms like trichomonas and mycoplasma genitalium into one multiplex test, Pais said, as well as developing tests targeting drug-resistant strains and identifying antimicrobial susceptibility.

The company has four patent applications filed so far. "We are constantly working with counsel to file more, either a continuation in part or new applications as we're progressing. We know that IP is really the most important thing for a startup in this space," Pais said.

It is also working with business mentors to come up with a go-to-market strategy and distribution strategy, with target customers likely to be STD clinics, family planning centers, physician office labs, and convenient care offices like urgent care centers and pharmacy labs.

The JHU Center

The Johns Hopkins center which funded the early work at Novel Microdevices is part of the Point of Care Technology Research Network, or POCTRN, a network created by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in 2007.

The center is just starting its third five-year center grant, director Charlotte Gaydos said in an interview. She recently learned the center will be funded with about $1.6 million for the funding year starting June 2019, bringing its funding since 2007 to more than $15 million.

"We have as a mandate from [NIBIB] and the ability to fund small start-up grants for people to do what we call tactical funding experiments," Gaydos said. This mechanism is intended to allow new companies to gather enough data to then be able to submit for further support to develop a point-of-care tests for STIs.

Gaydos said about 80 percent of the startups the center has funded in the last 10 years have gone on to get more funding. For example, the center provided early support to Atlas Genetics, the company now named Binx which just completed a clinical trial and is moving along the pipeline to commercialization.

The Binx test takes 30 minutes, "which fits the guidelines for what people want and what clinicians want," Gaydos said.

The center funded Novel Microdevices in its previous funding cycle, Gaydos said, and since then the company has gone on to win a $300,000 Phase I SBIR grant.

Last week, the center closed applications for the current cycle, having received an expression of interest from 16 companies. It picked 10 that it thought met the desired requirements, Gaydos said, and the applications will now be sent to external reviewers. The center will select three of these and provide them each $50,000 in funding for six months.

Then, "If they meet their milestones, they can apply for a second round of funding," Gaydos added.

In addition to supporting small startups developing POC devices for STIs, the center also has a core mission to perform needs assessment. Members of the center have conducted evaluations and published extensively on what end users and patients want in an STI point-of-care test.

The center also has a clinical core that looks at potential point-of-care tests that are mid-way through to developing a final test but may not yet ready to go into FDA clinical trials, to see how they work in a real-life situation, Gaydos said.

Typically, STI clinical samples can be more challenging matrices, containing mucus or other complex substances, she said. The center does evaluations on these real-life samples through a partnership with the Cincinnati Children's Hospital, the emergency department at JHU's hospital, as well as the Infectious Disease Institute in Kampala, Uganda.

The center can also test samples through its program called I Want the Kit, which allows individuals in Maryland, Washington, DC, and Alaska to order a free STI test online and collect the sample at home. This evaluation — which is done primarily in the service of public health and particularly targets teens reluctant to discuss their sexual history, as well as Alaskan natives who do not have good access to laboratory testing — can assess how a test in development fares on self-collected samples.

Gaydos said the center also works with the World Health Organization to identify tests that might be particularly useful in resource-poor countries.

She pointed out that guidelines recommend that all asymptomatic women under the age of 25 be screened annually for chlamydia and gonorrhea. Some guidelines have also recommended molecular testing.

Ultimately, the center wants to promote point-of-care STI testing and also testing that could someday be cleared for at-home use.

However, "It is a long pipeline" from the idea of a POC STI test, through validation in real human samples, getting enough money to do a clinical trial — which is very expensive, Gaydos said — and commercializing a test, particularly for home testing. "We're not there yet, but we're on our way," she said.