NEW YORK – BioMérieux executives on Wednesday highlighted recent and upcoming product launches expected to drive long-term growth in its molecular, microbiology, and immunoassay businesses, with a particular eye toward point-of-care testing.
In a conference call with investors to recap its fourth quarter and full-year results, BioMérieux CEO Alexandre Mérieux said the firm has "a very healthy pipeline of new solutions, systems, and menu, which will help us fuel growth for upcoming years."
Chief among these is the company's new SpotFire molecular diagnostics system, which obtained 510(k) clearance from the US Food and Drug Administration along with a CLIA waiver earlier this month.
The sample-to-answer system has several features designed for the point-of-care market, including high multiplexing and 15-minute time to results, and will run an anticipated five-target respiratory virus panel that includes a rhinovirus/enterovirus target and is potentially reimbursable in an outpatient setting.
Mérieux said on the call that the company will initially launch SpotFire in the US and will manufacture it on the same lines as the firm's FilmArray systems.
"It is a way for us to enter into the field of decentralized testing — this is CLIA waived, which means it can be used outside of the hospital," Mérieux said.
Pierre Boulud, the firm's chief operating officer and executive VP of clinical operations, said on the call that SpotFire also promises to expand the firm's respiratory testing footprint and allow it to enter the "low-plex" frontline testing market.
Boulud said that SpotFire will also strengthen the company's BioFire molecular testing franchise and that the firm expects SpotFire to bring in more than €400 million (currently $422 million) in annual revenues as soon as 2027. To put this in perspective, that is nearly as large as the firm's total immunoassay business in 2022.
Mérieux noted that the current size of the frontline low-plex molecular testing market is "massive," and includes competition from the Cepheid GeneXpert, Roche Liat, and Abbott IDNow. The market is about four times larger than the high-plex syndromic testing market, he said.
"We are moving from a relatively small market where we enjoy 70 percent market share to a much bigger market where we have zero market share," Mérieux said. "The uptake for us is a big question mark, but we genuinely believe we have a very competitive, differentiated, innovative solution," he added.
SpotFire's time to results of approximately 15 minutes for multiplex testing will be a differentiating factor, Boulud said.
"To give an order of magnitude, a Cepheid [GeneXpert] today is around 30 minutes, our [respiratory] panel is 45 minutes, and a Qiagen [QiaStat-Dx] panel is one hour," he said.
"Fifteen minutes is a very significant acceleration of the time to results for the lab, for the clinicians, and for the patients," he added.
One key to this projected success will be expanding the menu beyond the 15-target and five-target respiratory panels already disclosed.
"The holy grail for point of care is that they don't have too many instruments for each test they want to do," Mérieux said. Although he deemed it too early to disclose the menu in development, he said, "We really want to be able to promote the SpotFire as the go-to instrument when we go into point-of-care testing."
The firm is now studying the market size, competition, and potential for differentiation as it plans the menu. "We don't want to launch a 'me too,'" Mérieux said. BioMérieux expects to add to the test menu before 2027, and expects the projected, more than €400 million in revenues to come primarily from respiratory testing.
The firm expects the 15-plex SpotFire assay to be similarly priced to its FilmArray respiratory panel in the US, whereas the five-plex panel will need to have competitive pricing compared to others in the space, Mérieux said.
It is currently building up a commercial team to support the launch of SpotFire and sees instrument shipping capacity as a short-term limiting factor.
"When we have the full capacity from an instrument perspective, we will probably move toward having distributors in the US," Boulud said, adding that the five-plex assay will target the US in particular.
Mérieux also said the firm does not expect SpotFire to significantly cannibalize sales of FilmArray, which currently only has a marginal presence in the decentralized and point-of-care molecular testing markets.
Mérieux further highlighted that sales of the BioFire product line have been resilient.
Although the non-respiratory menu saw 19 percent growth in the year, the respiratory menu also had good performance in the fourth quarter during periods of high transmission of influenza, respiratory syncytial virus, and COVID-19.
Nevertheless, the firm has also seen higher competition in respiratory panel testing and experienced 2 to 3 percent price erosion globally, Mérieux said, but added he remains "pleasantly surprised" to have not lost much market share in syndromic testing.
The firm installed 300 new FilmArray instruments in the fourth quarter, bringing the total installed base to 23,500 systems. Mérieux said that while 70 percent of the total had previously been installed in the US, in 2022 half of the new installations were in Europe.
Microbiology and immunoassays
While SpotFire is expected to help drive future growth in BioMérieux's molecular biology business, Boulud said that the company's other clinical business divisions — microbiology and immunoassays — are also expected to benefit from the launch of "significant new systems" in the next 18 to 24 months, some of which will also push the firm further into the point-of-care space. These include the Vitek Reveal in microbiology and the Vidas Kube for immunoassays.
In microbiology, Mérieux said the company has so far already seen "good uptake" of its recently launched Vitek MS Prime, a load-and-go mass spec instrument that can prioritize urgent samples and is already FDA cleared and CE marked.
"With Vitek MS Prime, we expect to become the leader in the market," Boulud said, adding that the firm has been winning business away from its main competition since launching the system and that it expects to also open up new markets.
The firm also completed the acquisition of Specific Diagnostics in 2022 and is now initiating sales of the Specific Reveal system in Europe, rebranding it Vitek Reveal. BioMérieux is preparing an FDA filing for the Reveal this month and expecting US sales in 2024.
The Reveal system can provide the antibiogram from a positive blood culture within six hours and is modular to enable labs to scale according to their needs. It may be particularly useful for rapid gram-negative testing, Boulud said.
BioMérieux expects the Vitek Reveal to reinforce the firm's position in antimicrobial susceptibility testing (AST) and to generate more than $60 million in annual sales by 2027.
Meanwhile, the firm's immunoassay business struggled somewhat in 2022, falling 12 percent year over year in part due to an unfavorable comparison with COVID-related sales in 2021. Mérieux also described continued price- and volume-related competitive pressure on the procalcitonin business, but said that routine testing has returned to growth in many regions.
The firm also expects a full commercial launch of its Vidas Kube immunoassay system, which was CE marked at the end of 2022, in Europe and other parts of the world soon, Mérieux said. It plans to target developing countries with the system in particular, Boulud said, noting that it is currently in full-scale launch mode in the Dominican Republic, Italy, and India.
On Wednesday, BioMérieux also announced that it recently acquired an approximately 20 percent stake in Santa Clara, California-based immunoassay firm Proxim Diagnostics, which is developing a handheld immunodiagnostic device for point-of-care testing.
BioMérieux also recently launched a middleware solution called Maestria that can integrate its systems — including BACT/Alert, BioFire Blood Culture Identification, and Vitek MS Prime for blood culture and rapid microbial ID, and Vitek Reveal and Vitek 2 systems for AST — to enable comprehensive bloodstream infection testing, Boulud said.
"We believe we have now in this field [of sepsis testing] not only a very competitive solution, but an undisputed solution to be able to provide good diagnostic results to patients susceptible to sepsis," he said.