Natera, Inc., founded in 2004 and headquartered in Austin, Texas, is a global leader in cell-free DNA (cfDNA) testing, focusing on women's health, oncology, and organ health.
One of Natera's flagship products is the Signatera™ assay, a personalized, tumor-informed circulating tumor DNA (ctDNA) test designed for molecular residual disease (MRD) detection and cancer recurrence monitoring. In the fourth quarter of 2024, Natera processed approximately 150,800 oncology tests, including around 144,500 clinical oncology tests, marking a 54.7% increase from the 97,500 oncology tests processed in the same quarter of 2023. This growth contributed to the company's total revenues of approximately $472 million in Q4 2024, up from $311 million in Q4 2023, representing an increase of approximately 52%. For the full year 2024, Natera's total revenues reached approximately $1.7 billion, a 56% rise compared to $1.1 billion in 2023.
These financial results underscore the increasing adoption of the Signatera™ assay and Natera's commitment to advancing cfDNA testing technologies across its key focus areas.
I will highlight the JPM25 presentation, and give my opinion on where could Natera go from here onwards, with an emphasis in Screening products within Oncology Dx.
Natera started in 2013 with Panorama, a Non-Invasive Prenatal Testing assay (NIPT) that used cfDNA from the mother-to-be blood stream to identify any chromosomal anomalies in at the prenatal stage. It was only in 2019 when the company decided to also enter Organ Health and most relevantly Oncology.
The combo of Panorama (NIPT), Prospera and Signatera (CancerDx) continues to smash the records when it comes to total number of assays performed, and 2024 was a specially big year for NTRA, with a 26% increase overall.
The revenues also went up considerably, 52% higher YoY, with a steady increase on a per quarter basis, accelerating the growth rate with respect to 2023.
Natera broke into the green numbers in 2024, decidedly for the second half, with a total of $46M which is roughly $100M better than 4Q2023.
The numbers for Signatera also are positively growing, with 15K assays performed in the last quarter.
Crucially for Signatera, it’s got broad Medicare coverage with CRC, bladder, breast, and pan-cancer IO.
The company continues growing their readouts, with GALAXY, CALGB Alliance and IMvigor011 as highlights for 2024. More papers published.
The company presented at ASCO on GI cancers via the 702 randomized phase III CRC trial of Signatera.
Signatera is a multiplex PCR assay which gives extremely deep sequencing of the targeted regions. They can see the mutations disappearing after resecting the tumour out of the patient (right panel).
Now introducing “Signatera, developed on Genome”.
Next is the new tissue-free MRD for CRC. They also plan other tumors later. None of this is screening yet.
The three MRD detection products side by side. Signatera designed on Exome, Signatera designed on Genome and Tissue-free MRD (CRC) assay.
Below is a more technical description of the 3 assays:
Signatera "G64" is a combination of whole-genome sequencing (WGS) and 64 SNVs (via mPCR) to get down to single-digit parts per million.
Signatera "E16" is the Exome equivalent (WES) and 16 SNV assay.
The final MRD assay is a tumor-naïve MRD assay for CRC using methylation.
Now for the big bombshell below.