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JP Morgan Healthcare Conference, Day 2: CareDx, Thermo Fisher, BillionToOne, Adaptive Biotech, More

SAN FRANCISCO – The 43rd annual JP Morgan Healthcare Conference continued on Tuesday with companies in the diagnostics and genomics tools markets providing updates on their businesses and previewing what’s coming down the pike. 

Following are brief reports on individual presentations from the conference on Tuesday. Check elsewhere on our site for summaries of company presentations from Day 1Day 3, and Day 4.

CareDx 

CareDx CEO John Hanna said the firm is building out its diagnostic test pipeline over the next two years. The company plans to launch expanded indications for its AlloSure cell-free DNA organ transplant injury detection assay, including AlloSure SPK, a test for patients who have received simultaneous pancreas and kidney transplants, and an expanded indication for its AlloSure Heart test for pediatric patients under the age of 15. 

CareDx also has new products geared toward driving increased AlloSure Kidney utilization in the marketplace, including AlloMap Kidney, a gene-expression profiling test intended to help clinicians understand how a patient's immune system is accepting a kidney transplant. The company also plans to launch HistoMap Kidney, a tissue-based test that determines whether organ rejection is antibody-mediated rejection, cellular rejection, or mixed rejection "so that the clinician can treat differentially based on the type of rejection," Hanna said. 

UroMap, meantime, is a rule-out test to determine whether an elevated AlloSure Kidney result indicates BK virus, allowing clinicians to provide the correct follow-up treatment.

Hanna also provided a long-term financial guide for CareDx, saying that the firm is targeting $500 million in annual revenue in 2027 and expects a 15 percent three-year compound annual growth rate. Earlier this week, the firm said 2025 revenues are expected to total $370 million, up from an estimated $333 million in 2024.

Over the next three years, Hanna said the firm estimates that overall transplant procedures will grow in the mid-single-digit percent range, CareDx's test volumes will grow 7 percent, and its average test selling price will increase about 3 percent. 

CFO Abhishek Jain said that the firm expects its products business and its digital and patient solutions business to grow about 15 percent and its testing services volumes to grow in the mid-teens percent range in 2025. CareDx also expects Q1 2025 revenues to be slightly softer due to inclement weather across the US, growing at around 2 to 3 percent. Q2 revenues will likely increase about 5 to 6 percent, while Q3 revenues may also have lower growth rates due to seasonality, Jain said. 

Hanna cited transplant-adjacent areas the company may expand into, including autoimmune disorders, cardiovascular disease, lung diseases, and hematology disorders on the pre-transplant side. On the post-transplant side, CareDx could expand into high-risk areas for transplant patients such as infectious diseases or cancer, as well as therapeutic selection.

The company also plans to further expand into the cell therapy monitoring space with its AlloCell pharmacokinetic monitoring assay for immune cell therapy and its AlloHeme test for monitoring recurrence of malignancy, Hanna said. 

Thermo Fisher Scientific 

Thermo Fisher Scientific CEO Marc Casper said that 2024 was a "successful year," and he expects 2025 to be no different. 

The firm was able to achieve its revenue and operational goals in 2024, closed the Olink acquisition, succeeded in other capital deployment activities, and advanced its corporate social responsibility priorities, he said. 

Thermo Fisher launched many new products last year, including a new mass spectrometer and US Food and Drug Administration 510k-cleared assays. It also spent $4 billion on share buybacks, including $1 billion in the fourth quarter, and increased its dividend. 

Unlike many other life science tools companies, Thermo Fisher did not release preliminary 2024 financial results and will wait until its quarterly earnings call with investors. In the third quarter, the Waltham, Massachusetts-based firm reported revenues of $10.60 billion, flat year over year and below the average Wall Street estimate of $10.64 billion. Organic and core organic revenues were also flat compared to the prior-year quarter. 

Among the firm's 2024 highlights was a raft of product-related advancements. The National Cancer Institute launched the Myeloid Malignancies Molecular Analysis for Therapy Choice, or myeloMATCH, program, using Thermo Fisher’s Ion Torrent sequencers. The FDA also approved the Oncomine Dx Target test as a companion diagnostic for Servier's Voranigo brain cancer drug and gave 510(k) clearance for the Optilite Freelite assay for multiple myeloma precursors. 

Thermo Fisher also launched the One Lambda Transplant risk assay and the Stellar mass spectrometer last year. 

The firm's analytical instruments business has performed well lately, driven by the Stellar and Orbitrap Astral mass spectrometers, said Casper. "There's incredibly strong demand for high-end instrumentation," he noted. The inductively coupled plasma mid-range mass spectrometers have also contributed to the segment. 

Stimulus funding in China should also help drive instrument sales, with some orders made possible by the funds already coming in, though more should come in 2025 and 2026, he said, cautioning that the overall economy in China is weak. 

Casper, who spent several years as chair of the US-China Business Council, noted that Thermo Fisher is the "largest player" among life science tools firms in China but has half the exposure as a percentage of revenues in the tools industry, at 8 percent compared to an average of about 15 percent. 

Regarding Thermo Fisher's Olink acquisition, which closed in Q3 of last year, "integration is progressing really well," Casper said. The firm expects $125 million in adjusted operating income from revenue and cost synergies from the deal within five years, he noted. 

Last week, the UK Biobank announced that it had chosen Olink's technology to profile the plasma proteome in 600,000 blood samples. 

"This continues to validate that Olink is the platform for that area of research," said Casper. "It's exciting because customers like to go with the leader, and that has positioned us really well." 

BillionToOne 

BillionToOne CEO and Cofounder Oguzhan Atay said that the firm's prenatal testing business is already so profitable that "we do not need any additional capital to reach cash-flow positivity with fast growth." 

The Menlo Park, California-based molecular diagnostics firm recorded $153 million in revenues in 2024, more than double the $72 million it recorded in 2023 and exceeding internal projections of $125 million. It expects revenues of $220 million in 2025 and $330 million in 2026. 

The firm has built a 15 percent market share in US prenatal testing and is heading toward an average selling price of $400, with cost of goods sinking toward $100 per test, Atay said. 

He credited a "land and expand" strategy for driving growth, targeting just one provider within a practice at first who is willing to change to the firm's Unity Fetal Risk Screen sequencing-based prenatal test. "Once that provider has changed, it becomes easier and easier to get other providers," he said. 

The firm is now looking to grow its oncology liquid biopsy business with the help of $130 million in Series D financing announced last summer. Its Northstar Select and Response assays, for therapy selection and response, respectively, are already "seeing faster initial traction than what we saw with" prenatal testing, Atay said. Fourth quarter oncology test volume was approximately 3,000 tests, up from more than 2,500 in the third quarter. 

BillionToOne uses synthetic DNA spiked into samples to reduce errors and bias introduced during amplification of cell-free DNA. Atay said this technology offers a way to "achieve droplet digital PCR levels of precision with the flexibility of NGS." 

The Northstar Select test offers healthcare providers detection of 51 percent more single nucleotide variants and indels than competitors and more than double the number of copy number variants, while it reduces null reporting, Atay claimed. In one comparison, Northstar Response showed a partial treatment response 191 days earlier than an alternative test. 

The firm is also working on launching a minimal residual disease test, which will enter a market it values at around $30 billion.

After the presentation, Chief Product Officer Shan Riku told GenomeWeb that BillionToOne has approximately 500 employees and is seeking to add more than 100 by the end of the year. 

Adaptive Biotechnologies 

Adaptive Biotechnologies is hoping to bring its minimal residual disease (MRD) testing business to profitability in 2025, CEO Chad Robins said. 

Increases in both volume and average selling price should drive growth on the clinical testing side, while growth in testing for pharma could come from new studies using the company's ClonoSeq assay as an endpoint, enabled by a recent US Food and Drug Administration committee decision. 

In April, the FDA's Oncologic Drugs Advisory Committee unanimously voted to allow MRD as an early endpoint in myeloma clinical trials. "It's resonating across the industry," Robins said. "The use of a biomarker as primary endpoint is really special because it will provide accelerated approvals." 

The firm is integrating ClonoSeq ordering with electronic medical record systems — Epic for academic medical centers and Flatiron Health's OncoEMR for the community oncology setting — which it hopes will expand access and ease of use. The firm expects EMR-embedded orders to grow from 20 percent to more than half of all orders. 

Adaptive also announced on Tuesday an exclusive strategic commercial partnership with NeoGenomics to cross-promote ClonoSeq with NeoGenomics' diagnostic services. 

The company anticipates a ClonoSeq ASP of $1,300 per test on average in 2025, representing a 24 percent increase from 2023. Part of that is driven by Medicare setting a new gap-fill rate of approximately $2,000 per test, a 17 percent increase from the previous rate, which will help with both Medicare payments and negotiations with commercial payors. 

Adaptive also expects to save money on testing costs by transitioning its sequencing fleet. Instead of 33 Illumina NextSeq mid-throughput instruments, it will run two Illumina NovaSeq X instruments, beginning in the second half of the year. 

Bio-Techne 

Bio-Techne CEO Kim Kelderman emphasized that M&A is a top priority for the company, with a particular focus on assets that will help the firm grow its business in the areas of aiding in the discovery of novel biological insights and developing and manufacturing advanced therapeutics. The company's third growth area, enabling precision diagnostics, is also of interest for potential M&A activity. 

The M&A priorities under the first growth driver include analytical platforms, product tuck-ins, and targeted innovation capabilities. For therapeutic manufacturing, priorities are cell therapy workflow components and solutions and bioanalytical solutions. In precision diagnostics, M&A priorities include select innovation platforms and opportunistic tuck-in deals. 

M&A is "one of the most important dynamics" for Bio-Techne, and the firm is open to deals with public or private companies of any size, Kelderman said. However, he said that while the company has the financial health to be active in dealmaking, it will remain disciplined, noting that "we're not going to overpay, and certainly not stray too far away from our strategy." 

Kelderman also reflected on the company's presence in China, noting that Bio-Techne has seen stabilization after multiple quarters of declining revenues in the country. The firm expects to see normalization of its China business this quarter partially as a result of the country's stimulus program. 

"We're not saying it's going to go back immediately to its old glory," he said, but the company does expect to "be back in the black" soon. 

Hologic 

Hologic CEO Steve MacMillan said the company is interested in more midsize tuck-in acquisitions, such as its $230 million purchase of Biotheranostics completed in 2021, across each of the three segments of its business. 

Over the past five years, the firm has built its "tuck-in M&A muscle," which previously did not exist, MacMillan said. "We've gotten much better at identifying, integrating, and really making great use of our cash," he said, noting that Biotheranostics has more than tripled its revenues from about $30 million per year to $100 million per year since the acquisition. 

Since fiscal year 2020, the firm has spent $1.7 billion on M&A and $2.9 billion on share repurchases. The company ended fiscal year 2024 with approximately $2.4 billion in cash and cash equivalents, so it has "ample firepower" to fuel additional growth, he added.

Ideally, Hologic would have one midsize deal each year for each of the three segments of its business that would be accretive to the growth of the company, MacMillan said. 

The firm also released preliminary financial results for fiscal Q1 2025 earlier this week that were in line with the company's previous guidance. CFO Karleen Oberton said that the diagnostics business had exceptional growth, surgical health had solid growth despite some headwinds, and breast health was "probably a little disappointing." 

Oberton noted that the firm expected headwinds from tough respiratory testing comparisons between fiscal Q1 2024 and fiscal Q1 2025, but an acceleration in respiratory testing at the end of the quarter led to flat respiratory revenues year over year.