NEW YORK (GenomeWeb) – Quanterix has spent $5 million to fix reliability issues with its Simoa Analyzer platform and upgrade customers' instruments as it increases the multiplexing capabilities of the instrument and eyes a potential future in the diagnostics market.
Despite the kinks in the firm's single-molecule array technology, customer interest and sales of the Simoa instruments are growing fast, Quanterix CEO Kevin Hrusovsky told GenomeWeb in an interview this week.
"So far we've had a very positive response from it, and we hope to have upgrades completed by year end. He added that for the past three consecutive quarters, instrument sales have doubled year over year, and he expects the firm to have 80 instruments placed by the end of 2015.
The upgrades are just the start of Quanterix's plans for the Simoa platform. Hrusovsky said it has achieved new multiplexing capabilities, analyzing up to six different biomarkers at once, and has launched a new homebrew multiplex kit. The firm has also made the instrument 21 CFR Part 11 compliant, a benefit to pharmaceutical companies, which can now use the instrument to conduct pharmacodynamic and pharmacokinetic studies.
Quanterix launched the Simoa platform in 2013 and has been powering new research into detection of low and baseline levels of brain-related proteins, in particular. Having been awarded a National Football League and GE "Head Health Challenge" grant to study biomarkers associated with head trauma, Quanterix is well on its way to developing assays for those markers, as well as many other conditions where scientists are looking at inflammation.
"Across all diseases, we're seeing significant interest in our ability to measure cytokines, interferons, or interleukins at baseline levels," Hrusovsky said. "It really is helpful for customers to be able to know whether their drug is appropriately hitting the cytokines and have the desired effect on those and not have undesired effects on the immune system because of side effects."
Despite the growth in sales, Quanterix felt it needed to upgrade the instrument's reliability and performance, "given that it was somewhat prematurely pulled into the marketplace because of its disruptive nature," Hrusovsky said. Both hardware and software improvements are being made to the existing instruments at cost to Quanterix.
To address those reliability issues, Quanterix has re-engineered several parts of the hardware, including rack systems and sample bottles, Hrusovsky said. It has also reduced the amount of sample needed to run assays by 50 percent, he said, which is particularly important for scientists looking to do mouse studies where less sample material is available.
The software used to run the instrument also got a redesign. "We made it more intuitive," Hrusovsky said. "Before, it would be easy for a user to get into trouble because the software was in its first version. Now, we're able to guide the user and let them do the experiment without getting themselves into trouble when they're setting up the experiment, and it's easier to analyze [the data] post-run."
Jennifer Van Eyk, director of the Advanced Clinical Biosystems Research Institute at Cedars-Sinai Medical Center, has been using a Simoa instrument in her proteomics lab and told GenomeWeb that she has been pleased with both the instrument's performance and Quanterix's responsiveness to her lab's needs. "So far so good," she said. "We haven't gotten an upgrade yet, but we haven't had any real problems." She said the coefficient of variance, a measure of reproducibility, is "outstanding."
Her institute purchased a Simoa instrument last year and has been using it since October 2014 to look at low levels of proteins in cardiac disorders. For example, levels of troponin, a biomarker for heart attack, are often lower in women than in men, which can lead to underdiagnosis. Van Eyk has used several platforms to look at these types of proteins, and Simoa has yielded the best sensitivity, she said.
"We work a lot with companies on early development and sometimes you have to spend a huge amount of time and effort to get the instrument working," Van Eyk said. Not so with the Simoa, despite Quanterix's concerns about reliability. "It's good that they're proactive around that," she said. "Every instrument gets better with time."
Quanterix scientists have also pushed the Simoa platform to test more biomarkers at the same time. "Before, you were pretty much limited to singleplex," Hrusovsky said. "We've got 35 markers now that we've developed our own antibody kits for, but we also do a homebrew [multiplex] kit, so anybody can use their own antibody pairs and select their own protein of interest."
Researchers at the firm recently published a study showing they were able to detect six different inflammation markers at once. They published their results in May in the Journal of Immunological Methods.
Hrusovsky added that the firm is looking to launch a benchtop version of the instrument in 2017.
"The growth continues to accelerate," Hrusovsky said. "We've got a lot of adoption that's occurred with the current instrument."
Part of that growth is due to the firm's Simoa Accelerator program, which provides Quanterix's expertise to outside researchers for a fee. Hrusovsky said he's seen "over 100 percent growth in that category" and that about half of the partners often end up buying an instrument of their own.
But even customers that have their own Simoa Analyzer are coming back to the Accelerator program. "Many times they're looking for a multiplex assay to be developed for them in our accelerator so they don't have to do it themselves," Hrusovsky said. That trend could be fruitful long term, because it creates a pipeline of companion diagnostic opportunities that could have in vitro diagnostic potential, he said.
Because Quanterix has licensed Simoa IVD applications to BioMérieux, any research-use assay could follow the same path to approval. BioMérieux, however, has not yet blazed that trail; it has yet to get regulatory clearance for any Simoa-based IVD assays, Hrusovsky said. Still, that companion diagnostic potential is an attractive proposition for potential pharma customers looking at buying Simoa instruments, he said.
Pleased with Simoa's progress, Hrusovsky said that Quanterix is looking to conduct significant fundraising over the next few years. The firm is looking to raise private capital in the very short term and could be looking at an initial public offering as early as 2016, depending on market conditions.
"There's been a lot of interest in our company and our stock," he said. "We're still working out those details. I would say we'll probably be [raising] in the range of somewhere between $30 and $50 million" in the next private financing round.
"We believe we have a market we could impact that's [worth] $14 billion," he said, not only including research-use diagnostics in neurology, cardiology, oncology, and immunology, but also IVD in those areas. "We see very nice IVD revenues starting in the 2018 to 2019 timeframe," Hrusovsky said.