SAN FRANCISCO – Companies in the genomics tools and diagnostics markets continued to present their updates and news at the 43rd annual JP Morgan Healthcare Conference on Wednesday.
Below are brief reports on Wednesday's conference presentations by select companies. Check elsewhere on our site for summaries of company presentations from Day 1, Day 2, and Day 4.
Grail
Grail CEO Bob Ragusa talked to investors about the recent launch of a new version of Galleri, the firm's blood-based multi-cancer early detection test, noting that it should reduce the costs of goods and services.
Introduced in December, the new assay is "both fully automated and integrated," he said. Grail has eliminated "numerous" manual steps, leading to greater efficiency and improved quality control. It has also reduced the methylation sequencing panel "to the most informative regions," allowing four times the number of samples to be run on a flow cell, leading to reduced sequencing costs. Grail has also updated the test report, revising how the cancer signal of origin is classified and simplifying the report to 18 regions "to provide more valuable information to physicians," he said.
"We are transitioning to that new version of the test today and anticipate realizing the benefit from this investment as volumes grow over time," he said. "The implementation of these updates has substantially expanded our capacity" and can support "several years of growth" with no additional capital expenditure.
In 2024, Grail ran 137,000 Galleri tests, bringing the cumulative number of tests sold to more than 290,000, as of Dec. 31. That led to revenues of $124 million to $126 million, up 34 percent from the prior year. US Galleri sales were between $107 million and $110 million, up 45 percent from the prior year.
Ragusa noted that 2024 was an eventful year for the firm. In June, it completed its separation from Illumina and underwent a restructuring in August, cutting 30 percent of its workforce.
Grail has approximately $767 million in cash, providing a runway into 2028. Its cash burn in 2024 was $579 million; however, it has reduced its burn rate "substantially" and expects to go through less than $320 million in 2025.
In 2025, Grail expects US Galleri sales to grow between 20 percent and 30 percent year over year. "This reflects the reduced investment that we're making in [our] commercial [team] as we work towards achieving commercial spend neutrality," Ragusa said.
The year should also see the early readout of the firm's Pathfinder 2 study on Galleri's performance, he said.
Grail intends to eventually submit a premarket approval application to the US Food and Drug Administration for Galleri and pursue broader payor reimbursement for the test.
Ultima Genomics
Ultima Genomics has been powering large-scale studies that make use of high-throughput sequencing, according to CEO and Cofounder Gilad Almogy.
The company did the sequencing for a recent 100 million cell dataset created by Vevo Therapeutics in partnership with single-cell firm Parse Biosciences. Vevo plans to use the dataset to train artificial intelligence cell models for use in drug discovery. "That's the scale of data you need if you want to really train AI," Almogy said, adding that Ultima generated approximately 2 trillion reads in three weeks late last year for the project.
Ultima is also providing sequencing services for the 100 million cell challenge partnership among Scale Biosciences, Nvidia, and the Chan Zuckerberg Initiative. In addition, the company announced last week that it was chosen as the sequencing provider for the UK Biobank's Pharma Proteomics Project. The study, conducted in collaboration with 14 biopharma companies, will look at 5,400 proteins in 600,000 samples using Thermo Fisher Scientific's Olink protein capture technology.
"Beyond the science, the fact that 14 large pharma customers chose to go with us after an extensive, diligent [selection] process is very encouraging," Almogy said.
He predicted that the drive to feed AI virtual cell models would help create demand for the firm's high-throughput, low-cost sequencing services and products. "100 million cells looks big now," he said. "It will look like a joke in a few years."
In 2024, Ultima launched a new certified service provider program. South Korea's Macrogen, San Diego-based Inocras, and the University of Minnesota are already part of the program, which Ultima plans to expand in 2025.
The company did not share any updates on placements or revenues.
In the coming year, the firm plans to work on increased automation, improved flexibility and adaptability, as well as lower cost and increased throughput. "We want to keep improving the core economics and make it easier to switch to us and keep people thinking of larger experiments," Almogy said.
Seer
Despite a challenging 2024, proteomics firm Seer believes its growing publication record and planned product and application launches will make for a "much stronger 2025," said Chairman and CEO Omid Farokhzad.
Farokhzad noted several developments at the company over the course of the last year, including the publication of 32 peer-reviewed articles involving its technology, a doubling of the firm's commercial team, and the signing of a comarketing and sales agreement with Thermo Fisher Scientific.
While Seer's full-year 2024 revenue guidance of $13 million to $15 million is below its 2023 and 2022 revenue numbers of $16.7 million and $15.5 million, respectively, there were some encouraging signs as the company grew both its product and service revenue in Q2 and Q3.
"2024 was a tough year from a macro environment standpoint," said Seer President and CFO David Horn, adding that "the first half of the year was especially difficult."
"But we did see some loosening up of budgets from folks in the second half of the year, and I think that is encouraging as we move into 2025," he said.
Farokhzad highlighted the performance of the company's Seer Technology Access Center (STAC), through which researchers can use the firm's Proteograph XT assay with the Orbitrap Astral mass spec, noting that its customer base, which he said includes 12 large pharma firms, has doubled over the last year to more than 90 organizations while revenues from the center grew 69 percent year over year.
Farokhzad added that Seer plans in February to launch a new product application enabling the use of its Proteograph Product Suite in cell lysate samples.
He said the company has additional new products planned for 2025.
"It's really an exciting year in terms of our R&D roadmap, and obviously scale, speed, and ease are the three dimensions that we are focused on," he said.
GeneDx
GeneDx has made "important" product improvements to its rapid whole-genome sequencing (rWGS) product in 2024 that should help it unlock genomic testing in the neonatal intensive care unit setting, CEO Katherine Stueland said Wednesday at the conference.
The firm has revamped the assay to "close some gaps on repeat expansions" and to take buccal or cheek swabs as a sample type. Turnaround time has also been brought down to about five days from 12 to 14.
GeneDx has also invested in integrating its rWGS results with Epic Systems' Aura specialty diagnostics module. "We're going to turn it on in the second quarter of 2025," she said, noting that NICU orders only represent single-digit percentages of GeneDx's current test volume. Stueland also highlighted the firm's work on sequencing-based newborn screening.
Earlier in the week, GeneDx announced preliminary Q4 revenues of at least $92 million, up 59 percent year over year, and at least $299 million for the full year, up 54 percent year over year. The Q4 results included $6.8 million that was an appeal recovery from a single payor, Stueland said.
Looking forward, the firm is hoping that the American Association of Pediatrics will update its genetic testing guidelines for the first time in a decade. Converting general pediatricians from using chromosomal microarrays could help unlock what GeneDx sees as a $25 billion market opportunity in pediatrics.
Stueland said GeneDx is also planning to move into adult testing, markets that include cardiovascular and neurodegenerative disorder testing. There is "more and more investment going into gene therapies" for those diseases, she said, and "we want to be a partner of choice for those biopharma companies."
Quanterix
Quanterix CEO Masoud Toloue on Wednesday provided additional information about the firm's acquisition of Akoya Biosciences and a new platform launch coming in 2025.
The firm's new Simoa One platform is expected to launch at the end of the year, Toloue said, noting that it will be up to 10 times more sensitive than its current Simoa protein biomarker detection system with up to a tenfold increase in multiplexing. The new platform will include Code Match technology, optically encoded barcodes on proprietary emission beads that will allow the platform to "grow plex while maintaining high specificity across the assay," Toloue said. The platform will also have a three-hour turnaround time.
Simoa One will be particularly helpful in Quanterix's goal to move into the oncology market and further expand its presence in the immunology market due to its high sensitivity, he added. While it will likely be used in the neurobiology business eventually, Toloue said the initial focus will be on immunology and oncology.
Toloue also provided additional information on the firm's acquisition of Akoya Biosciences announced last week. The acquisition will "uniquely position" the combined company to enter the oncology market, he said. In addition, the firm's installed base will double from Quanterix's 1,000 instruments to 2,300 instruments once the deal closes.
The two companies had combined revenues of approximately $220 million in 2024, and Toloue said he expects strong double-digit organic revenue growth by 2026. They are developing tissue- and blood-based complementary biomarker kits that will be available in 2025, Toloue added. "The combination provides us an accelerated path to scale [and] profitability, with a focus on great, high-growth markets," he said.
Quanterix is also beginning to enter the clinical diagnostics market with its Lucent Diagnostics CLIA-certified laboratory in Boston. The firm's five-marker LucentAD Complete test for determining the likelihood that a patient has the amyloid brain pathology characteristic of Alzheimer's disease is currently being offered as a laboratory-developed test. The company has submitted for a proprietary laboratory analyses code, which it expects to receive along with pricing from the US Centers for Medicare and Medicaid Services in 2025, Toloue said.
Quanterix expects reimbursement through CMS's Advanced Diagnostic Laboratory Tests pathway in 2026.
Over the course of 2024 and 2025, Quanterix will have invested $20 million in Lucent Diagnostics, including funding its four ongoing prospective studies for LucentAD Complete that will complete enrollment in 2025 as well as building out laboratory capacity and a dedicated commercial team.