NEW YORK — Sera Prognostics expects recent and coming peer-reviewed publications will allow it to begin to ramp up sales next year of its PreTRM test for predicting the risk of preterm birth.
At the same time, the company plans to launch in either late 2024 or early 2025 a direct-to-consumer proteomic blood test for predicting a pregnant woman's likely due date.
Sera's PreTRM test measures the ratio of insulin-like growth factor binding protein 4 (IGFBP4) to sex hormone binding globulin (SHBG) to assess the likelihood that a woman will deliver prematurely. Administered between weeks 18 and 20 of pregnancy, the test is intended for use in women with normal singleton pregnancies and no history of preterm birth. While preterm birth is a major driver of infant mortality and morbidity as well as a significant contributor to healthcare costs, there have historically been no effective tests for it in the average-risk population.
Sera launched PreTRM in 2017 through a licensing deal with Laboratory Corporation of America, but sales of the test have never generated meaningful revenues for the company. Its strategy, explained by former CEO Gregory Critchfield in previous interviews with 360Dx, has been to secure insurance coverage for the test before investing in a serious commercial rollout. In the absence of such coverage, Sera, which went public in a $75 million initial public offering in 2021 (which priced the company's stock at $16 per share), posted $306,000 in revenue in 2023, $268,000 in 2022, $82,000 in 2021, and $25,000 in 2020.
The company hopes that recent and forthcoming publications along with several changes it has made to improve the efficiency and cost of its testing platform will position it for a broader commercial launch beginning next year, said President and CEO Zhenya Lindgardt. She said that Sera expects to line up its first payor coverage for the test in 2025 and that it believes it will be possible, based on that coverage, to "generate orders of magnitude higher sales" next year.
This month, a team led by clinicians at Delaware healthcare provider ChristianaCare, published data from the Sera-funded AVERT PRETERM trial, which looked at outcomes for individuals identified as high-risk by PreTRM and subsequently treated with vaginal progesterone, daily aspirin, and increased monitoring. Compared to historical controls, the babies of mothers receiving testing and treatment had an 18 percent reduction in severe morbidity and a roughly 25 percent reduction in birth before 32 weeks.
Sera also hopes in coming months to publish results from its PRIME (Prematurity Risk Assessment Combined with Clinical Interventions for Improved Neonatal Outcomes) study, which the company launched in 2021 in partnership with health insurer Anthem and its HealthCore subsidiary.
In December, the company announced that the data safety monitoring board overseeing the study recommended that it end study enrollment early due to strong interim results.
Sera has also made changes to the PreTRM test format and platform in preparation for broader commercialization, Lindgardt said. It has moved from venous blood draws for sample collection to fingerprick blood collection using Neoteryx's Mitra microsampling device. This, Lindgardt said, will streamline the sampling process, allowing patients to give a sample in their physician's office or even sample themselves at home. She noted eliminating the need to schedule a blood draw with a third-party is important for ensuring patients receive testing within the required window.
Additionally, Sera altered the mass spectrometry workflow used to run the test, eliminating the upfront liquid chromatography and instead using immunoaffinity capture to purify samples for analysis. The shift makes for a faster and less expensive workflow, Lindgardt said. During the company's Q1 2024 earnings call, she said these changes could boost throughput by tenfold while cutting turnaround time in half and reducing the test's cost of goods by 60 percent.
As a laboratory-developed test, PreTRM is now subject to increased US Food and Drug Administration oversight following the agency's issuance of its final rule on LDTs. Lindgardt said Sera is taking the test, including the self-sampling version, through the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP), which, under the rule, offers an alternative pathway to market for many tests.
Lindgardt said the company is also engaging with the FDA in case a submission to the agency is ultimately needed.
She said that as the company ramps up its commercial activity following the anticipated positive payor coverage decisions, it will focus on large accounts at institutions delivering tens of thousands of babies per year, which, she noted, will allow it to scale sales quickly.
It remains to be seen whether the AVERT PRETERM trial and forthcoming PRIME data will be sufficient to secure payor coverage and drive clinician uptake. In 2021, a report from the American Association for Clinical Chemistry (now the Association for Diagnostics & Laboratory Medicine), recommended against the use of the PreTRM test as well as other potential preterm birth markers including the proteins fetal fibronectin (fFN), interleukin 6 (IL-6), and placental alpha microglobulin-1 (PAMG-1), citing their insufficient positive predictive value.
The report authors also highlighted in a 2022 comment that in a 1,191-subject prospective trial, testing with PreTRM combined with use of interventions aimed at preventing preterm birth did not significantly reduce rates of spontaneous preterm birth. That trial, however, was underpowered and stopped early due to what the authors said were "limited resources."
The AVERT PRETERM trial was designed to assess the impact of the overall test-and-treat protocol, making it impossible to isolate the specific contribution of the PreTRM test and its ability to select for high-risk patients to the improvement in outcomes. Sera CSO Jay Boniface said that the PRIME study data will allow for such an assessment.
Matthew Hoffman, chair of obstetrics and gynecology for ChristianaCare and a leader of the AVERT PRETERM trial, said his department is currently having conversations around whether to recommend use of the PreTRM test. He added that he and his colleagues "are looking very much forward to the PRIME results" and that "we need to have discussions with our insurers, as well."
In addition to PreTRM, Sera has several other products in its pipeline. The company plans to launch a predictive analytics product based on data it has collected on over 20,000 pregnancies through its studies on the PreTRM test. The product will help predict various pregnancy outcomes such as above-average weight gain or early cesarean delivery.
The company is also developing a proteomic test for predicting a woman's delivery date. Sera has not published data on the test, but Lindgardt said that it has demonstrated higher accuracy than traditional algorithms for predicting delivery dates and will be a planning tool for expectant mothers.
An immunoassay that uses fingerprick blood samples, the test is a home test, and Sera will offer it as a self-pay product. Lindgardt did not provide specific pricing for the test but said it will be comparable to other consumer diagnostic tests, which she noted commonly sell for $100 to $200. She said Sera plans to launch the test in late 2024 or early 2025.
Lindgardt did not say whether Sera believes it will need to take this test through the FDA but said the company plans "to follow the FDA expectations for any test we currently have or plan to pursue that is within the FDA's jurisdiction."