
SAN FRANCISCO – Companies in the diagnostics and genomics tools markets wrapped up the last day of the 43rd annual JP Morgan Healthcare Conference with updates about their businesses and the industry.
Below are brief reports on conference presentations by select companies on Thursday. Click here, here, and here for 360Dx's coverage of conference days 1, 2, and 3, respectively.
Standard BioTools
Standard BioTools CEO Michael Egholm said the firm has "reached a tipping point" for its SomaScan proteomics technology, calling it the "crown jewel" of its product portfolio.
More than 1,000 studies have now been published using the technology, which can assay thousands of proteins in blood. "More importantly, we're seeing pharma companies publishing on how they use our tech," he said.
Earlier this month, researchers from Novo Nordisk published a paper in Nature Medicine on their use of SomaScan to assay more than 6,000 proteins in a 1,900-person cohort that had been treated with semaglutide, also known as Ozempic or Wegovy. They were able to see proteomic changes in the patients after treatment and "elucidate the mechanisms of action for all the benefits this drug class has," Egholm said, including cardiovascular health benefits.
With Illumina set to launch a distributed proteomics assay based on SomaScan and next-generation sequencing as a readout, the technology is set to "reach its full potential," he said.
"We're at an amazing point in time," Egholm said. "Pharma is fully embracing it. We have proof we can scale to [cover] half the proteome, which has always been a question. And now we have the enabling breakthrough with Illumina."
Earlier this week, Standard BioTools said it expects fourth quarter revenues of $46.5 million, up 65 percent from the year-ago quarter, beating the consensus Wall Street estimate of $43.0 million. For full-year 2024, the firm expects revenues of $174.0 million, up 64 percent year over year and beating the consensus Wall Street estimate of $171.2 million.
Egholm noted that a year after acquiring SomaLogic, the company has already reduced that firm’s operating expenses by $80 million.
Consistent with its modus operandi, the firm is planning to acquire four to six companies over the next two years, Egholm said, noting it was an "opportune" time to be buying companies or technologies.
"The market desperately needs consolidation," he said. "Valuations are down, funding is down, but innovation hasn't stopped. In fact, I would argue there's more innovation than ever."
Sera Prognostics
Sera Prognostics President and CEO Zhenya Lindgardt presented preliminary data from the firm's PRIME (Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes) trial for its PreTRM proteomic blood test.
While final results will be presented later this month at the Society for Maternal-Fetal Medicine Conference and on a webcast next month, Lindgardt said that the randomized controlled trial showed use of Sera's test in pregnant women who consented to accept treatment led to a 25 percent reduction in health complications and an 18 percent reduction in length of hospital stay for neonatal patients.
Use of the mass spectrometry-based test in all pregnant women included in the study also led to a 22 percent reduction in admissions to the neonatal intensive care unit for newborns and 8 percent fewer days in the hospital for babies admitted to the neonatal intensive care unit.
The firm plans to use the results of the PRIME study, as well as its previously reported AVERT study, to make an economical and clinical case for payor coverage of the test, Lindgardt said. Sera is also engaging with guideline-setting bodies such as the American College of Obstetricians and Gynecologists to provide clinical evidence to potentially include the test in prenatal testing guidelines, she said.
In addition, Sera Pro is launching an investigator-initiated research program and multiple real-world evidence studies to build out its data. While the company plans to engage with commercial payors, it also intends to work with state Medicaid agencies to potentially develop pilot programs to show the benefits of its test-and-treat strategy, Lindgardt said. The company's commercial strategy will depend on payor coverage and engagement with state plans.
"As we get reimbursement, as we get green shoots on collaborations with Medicaid agencies, we will double down in those states to reach density of adoption of the PreTRM test-and-treat strategy and then use those business cases to go from geographic area to geographic area to scale," she said.
If the company receives reimbursement from a national payor more quickly, however, Sera will accelerate the build-out of its sales force or work with commercial partners to "go much more aggressively to educate the community with feet on the street," Lindgardt added.
OraSure Technologies
OraSure Technologies CEO Carrie Eglinton Manner said in her presentation that the firm's recent $25 million acquisition of Sherlock Biosciences represents the company's commitment to increase innovation in its diagnostics and sample management businesses through internal and external opportunities.
The Sherlock acquisition, announced last month, will allow OraSure to further penetrate the instrument-free molecular diagnostics market with its upcoming Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) test, which is currently undergoing clinical trials. The company expects to submit the 30-minute test for US Food and Drug Administration approval for over-the-counter use by the end of this year, Manner said.
Meantime, the firm's $30 million investment and distribution agreement with Sapphiros will help it expand further into the digital lateral flow and molecular point-of-care markets, as well as new sample types, Manner added. Sapphiros' SatioDot and SatioDraw at-home blood collection devices are expected to launch this year.
OraSure is also launching a research-use-only blood-based proteomics product in 2025 that utilizes specific chemistry to provide protein-specific sample stabilization at ambient temperatures and will be compatible with a broad range of proteomic methodologies, Manner said.
According to Manner, the company's strategy for capital deployment has been to invest in companies with innovative diagnostic opportunities or new sample management types and analytes, whether that is through distribution agreements or M&A. "The distribution agreements we have done have purely been about expanding access to innovation," she added.
OraSure has been and continues to be willing to explore both organic and inorganic opportunities. "We're diligently continuing to look, and we've got a cash balance that allows us to do that," Manner said.
Geneoscopy
Geneoscopy CEO and Cofounder Andrew Barnell discussed the importance of the firm's partnership with Laboratory Corporation of America as it rolls out commercial access to its ColoSense test for colorectal cancer following approval by the US Food and Drug Administration last year.
Labcorp was one of the investors in the firm's $105 million Series C financing round, announced earlier this month.
The firms also signed a multiyear agreement last summer to increase access to ColoSense, a CRC screening tool that analyzes RNA from stool samples. Having Labcorp as a partner on the front end makes it "easy to integrate our tests into existing contracts," Barnell said. Moreover, the clinical lab giant has a large distribution network and sales reps that can help sell primary care and other physicians on the test. Labcorp is the leading fecal immunochemical test provider in the US, he noted.
"Inbound interest has been huge since FDA approval," he said, and the firm is hoping its test will soon be included in a national coverage determination (NCD) for CRC screening. Last year, Geneoscopy made a request to the Centers for Medicare and Medicaid Services to reconsider the NCD to including stool-based RNA tests. Though it's hard to know exactly when that might happen, Barnell said, "we expect it to be added, and we expect it to be this year."
He did not provide specifics about a launch timeline for ColoSense but said it will also be this year.
Geneoscopy is expecting the US Patent Trial and Appeal Board to soon make a decision on whether to institute inter partes review of an Exact Sciences patent that is central to a lawsuit between the firms.
Barnell also spoke about the firm's plans to expand into inflammatory bowel disease testing, including sponsoring a study on IBD "to begin product development outside of our pharma partners."
"We have the perfect platform to service this entire market," he said.