Billiontoone (NASDAQ:BLLN) outlined its strategy for growth in molecular diagnostics during a presentation at the William Blair Growth Stock Conference, with Chief Executive and co-founder Oguzhan Atay emphasizing the company’s single-molecule testing platform, expanding prenatal and oncology product portfolio, and recent profitability metrics.
Atay said BillionToOne is “redefining what is possible with molecular diagnostics” through its patented QCT technology, which he said enables single-molecule-level sensitivity and precision. The company applies the platform across cell-free DNA testing in prenatal care and oncology, two areas where Atay argued existing tests are limited by noise introduced during amplification and sequencing.
Company Highlights Revenue Growth and Profitability
Atay said BillionToOne has grown to a $434 million annual revenue run rate in six years. He said first-quarter revenue grew 84% year over year, driven by higher test volume and improved contracting and coverage, which contributed to a 28% year-over-year increase in average selling prices.
The company also reported a 73% gross margin profile in the first quarter, according to Atay. He said BillionToOne has achieved “significant GAAP profitability,” with first-quarter GAAP operating and net margins of 16%. He attributed the company’s financial performance to fiscal discipline, efficient operations and the incorporation of AI.
Atay said the company has reached profitability with “only 10% of the accumulated deficits” of its public competitors, while continuing to invest in product development and new data releases.
Prenatal Testing Portfolio Expands
Atay said BillionToOne first applied its technology in prenatal testing through UNITY, a non-invasive prenatal test designed to detect single-gene recessive conditions such as cystic fibrosis and sickle cell disease without requiring paternal DNA.
According to Atay, traditional carrier screening methods that rely on partner testing miss many affected pregnancies because of challenges including missing paternal screening and misattributed paternity. He said UNITY detects three times more affected pregnancies than traditional carrier screening methods that depend on partner testing.
Atay described a real-world case involving a pregnant patient whose UNITY result indicated a high risk for cystic fibrosis. He said the diagnosis was confirmed by amniocentesis, after which the insurer approved Trikafta for treatment in utero. Atay said prenatal therapy began at 27 weeks, ultrasound findings resolved, the baby avoided the NICU and passed newborn screening.
The company has also launched additional prenatal tests, including RhD NIPT, fetal antigen NIPT and FNAIT NIPT, Atay said. He also highlighted the recent launch of UNITY Confirm, which he described as a product intended to address uncertainty following positive NIPT screening results by using intact fetal cells from maternal blood.
Oncology Business Focuses on Liquid Biopsy
In oncology, Atay said BillionToOne’s Northstar platform includes two tests for late-stage cancer patients: a therapy selection test and a response monitoring test. The therapy selection test is designed to identify tumor mutations from a blood sample, while the response monitoring test aims to determine whether a patient is responding to therapy by quantifying changes in tumor burden.
Atay said the company conducted prospective head-to-head comparisons in which physicians sent same-day blood samples to both their liquid biopsy test of choice and BillionToOne. He said Northstar detected 50% more actionable single nucleotide variants and more than 100% more actionable copy number variants than competing tests in those comparisons.
He also said 69% of alterations missed by other tests were clinically actionable. In one example, Atay described a stage two rectal cancer patient whose tissue next-generation sequencing test was negative. He said Northstar detected MSI-high status, which opened the option for immunotherapy.
Atay also said BillionToOne has developed a panel-wide clonal hematopoiesis filter to reduce false positives caused by white blood cell-derived alterations. He said the approach combines machine learning with buffy coat sequencing and has achieved more than 99% accuracy for clonal hematopoiesis calling across clinically actionable variants.
Response Monitoring Data Presented
Atay discussed data on Northstar Response, saying the company has shown that changes in tumor burden from baseline to three months in immunotherapy patients can predict long-term outcomes. He also referenced new data presented at ASCO, saying the company’s molecular progressive disease measure showed better performance than scans and added value when scans classified patients as non-progressors.
He said longitudinal monitoring data from the company’s NORTH study showed that patients classified as progressing molecularly had significantly worse progression-free survival and overall survival.
Looking ahead, Atay said BillionToOne plans to continue launching new products and data sets while pursuing markets where cell-free DNA testing remains limited by existing technologies. He said the company’s long-term ambition is to become a category-defining molecular diagnostics company.
About Billiontoone (NASDAQ:BLLN)
BillionToOne (NASDAQ: BLLN) is a molecular diagnostics company that develops and commercializes high-precision genetic testing solutions based on single-molecule counting technology. The company’s platform is designed to detect and quantify rare genetic variants and chromosomal abnormalities from cell-free DNA, with a primary focus on applications in prenatal screening and other clinical genetic tests where sensitivity and specificity at very low allele fractions are critical.
BillionToOne’s offerings center on assay development and clinical testing workflows that enable non-invasive prenatal testing (NIPT) and targeted molecular diagnostics.
