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NeuMoDx Enters High-Volume MDx Instrument Market

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NEW YORK (GenomeWeb) – NeuMoDx has entered the market for high-volume clinical lab testing with a new US Food and Drug Administration-cleared instrument that it believes has unique properties to compete with well-established players in the space as the company expands its menu of in vitro diagnostic tests.

The FDA granted 510(k) clearance to the Ann Arbor, Michigan-based firm's high-throughput molecular diagnostics platform — called the 288 Molecular System — along with a Group B Strep assay last month.

According to NeuMoDx Chief Commercial Officer Dan Harma, while other high-volume systems are already on the MDx market, several features differentiate his firm's platform. For example, unlike several other systems that have separate modules for extraction and detection, the NeuMoDx system is fully integrated, performing every step from sample extraction to detection on board, driven by a combination of microfluidics and robotics, Harma said in an interview.

The system also allows random, continuous access. Testing continues even when users load additional specimens, consumables, or reagents, and this "allows for continuous walk-away for up to eight hours," Harma said. NeuMoDx also uses proprietary dried reagents, which he noted can reduce waste and extend storage time onboard the system compared to other commercial instruments.

The NeuMoDx system can be loaded with 288 specimens, and users can run assays for up to 30 different targets at a time on strips that contain 16 tests, allowing for a capacity of up to 480 total tests. "Because it is random, continuous access, if you have 480 tests loaded and you go through your first 288 samples, you can add additional specimens as they arrive," Harma explained, including running tests one at a time, if needed. The instrument is also HL7-compliant and has a bidirectional laboratory information system interface.

Further, it boasts a 60-minute turnaround time for first results, due in part to the microfluidics and silicon heater thermal cycling.

The system is intended for high-throughput, high-volume clinical laboratories, such as regional and national commercial labs, core labs, and academic medical centers, as well as centers that have a high volume of labor and delivery patients, Harma said. NeuMoDx is currently finalizing its commercial efforts, he said, and he declined to comment on the cost of the instrument, reagents, and consumables.

NeuMoDx started off in 2012 with $5 million in Series A financing, then raised $21 million in a Series B funding round in 2014.

The firm was established by the former CEO of HandyLab, Jeff Williams, along with that firm's cofounder, vice president of R&D, and leader of product development, Sundu Brahmasandra. HandyLab was acquired by Becton Dickinson in 2009 for $275 million, and the firm's HandyLab Jaguar system evolved into the BD Max.

"Sundu and I have both been in molecular for a very long time," Williams said in an interview. "We know the space well, know the customers well, and know the competition well, and feel like the NeuMoDx system is the next logical progression for our customers and for the market to take in molecular diagnostics.

"We think that we will be able to achieve reasonable penetration with the system over the next year or two, especially as the menu grows," he added.

The motivation to develop a new molecular diagnostics instrument came from his and others' perception of an unmet need in the market, Williams said, even though "significant progress" was being made in the MDx space by a number of firms that were producing sample-to-result systems.

What was missing, he said, was an instrument that would be akin to a clinical chemistry analyzer where everything needed to run a test is stored on a walkaway system. This ideal system would need to be fully automated, have continuous access and random access, and provide the ability to obtain more than one test result from a specimen tube without limitations on storing the inventory onboard the system, he said.

"NeuMoDx offers the first opportunity [in the high-throughput molecular diagnostics market] to ... walk up, put specimen tube in, hit start, and walk away," Williams said.

In terms of high-volume molecular diagnostic instruments, the company will face competition from a number of prominent manufacturers, like Roche, Abbott, and Hologic.

Harma said that in the initial stages NeuMoDx may be hard-pressed to compete purely on menu as the MDx instrument space "is starting to be a menu-driven business."

However, the firm has an advantage in its ability to run lab-developed tests in a "much more efficient and automated manner," he said, adding that most other vendors have some off-line aspects or special channels required for LDTs.

Specifically, instruments with the potential to run IVDs as well as LDTs include the Cobas Omni Utility Channel on the Roche Cobas 6800 and 8800, the Abbott m2000 and Alinity m molecular diagnostic test platforms, and, potentially, the Hologic Panther Fusion system.

"As our menu continues to be fleshed out with IVD assays, we'll be able to more efficiently offer LDTs and IVDs simultaneously with multiple specimen types and multiple tube types," Harma said.

The capacity to run LDTs and IVDs simultaneously was one of the design criteria developed from discussion with customers, Williams said. "They requested that it be simple to do, so we spent a lot of time and effort on making it be extremely easy for the customer to operate," he said. There are FDA requirements stipulating customers provide their own primers and probes, but NeuMoDx provides all other consumables, reagents, and master mix, which "makes it a much more usable system, we believe, than anything else on the market," said Williams.

While the proportion of IVDs to LDTs being run by a lab varies widely, LDTs are a "very important component," Williams said.

A typical IVD menu tends to include "the big five" of chlamydia, gonorrhea, hepatitis B, hepatitis C, and HIV, as well as a few other targets, such as human papillomavirus, methicillin-resistant Staphylococcus aureus, or Clostridium difficile.

"Any other assay that you want to run on the system, by definition, is a lab-developed test," Williams said. "There is still a huge need" for LDTs, he said, noting in particular that viral load monitoring assays for viruses like BK and CMV, which are commonly carried by healthy adults but can be lethal to transplant patients, are typically run as LDTs.

Williams also added that the firm will be making a significant push in Europe and outside of the US. "In that market, we currently have a much larger menu and the menu is developing much more rapidly," he said.

The firm's FDA-cleared GBS test is CE marked, as is a NeuMoDx test for CT/NG. The firm is in the process of obtaining CE mark for bloodborne virus assays, including HBV, HCV, and HIV, and it is also developing assays for cytomegalovirus and Trichomonas, as well as others, Williams said.