BillionToOne, Inc. (NASDAQ: BLLN) has launched two new add-on tests designed to improve cancer treatment decisions from a single blood draw. The molecular diagnostics company introduced Northstar PGx and Northstar Select CH as enhancements to its existing Northstar Select liquid biopsy platform.
The company said on Monday that the additions expand the platform beyond tumor profiling to address chemotherapy safety and biological false positives.
Northstar Select already identifies genetic mutations in advanced solid tumors through a blood sample. In a head-to-head clinical study, the test detected more than 50 per cent additional clinically actionable alterations compared with other methods. Consequently, physicians can uncover more treatment targets without performing invasive tissue biopsies.
Northstar PGx adds pharmacogenomic analysis to that same workflow. The test evaluates key genetic variants in the DPYD and UGT1A1 genes. These genes influence how patients metabolize common chemotherapy drugs such as fluorouracil and irinotecan. Additionally, major oncology guidelines and U.S. Food and Drug Administration labeling recognize their importance in treatment safety.
The company said Northstar PGx reports a patient’s predicted metabolizer status from the same blood sample. It also provides clinical context that may help doctors adjust dosing or monitoring plans. Furthermore, the company maintained that it delivers these insights without extending the average five-day turnaround time.
Recent guideline updates have urged broader testing to reduce chemotherapy toxicity risks. For example, experts now recommend DPD deficiency testing before prescribing certain fluoropyrimidine therapies. Consequently, integrating pharmacogenomic data into routine liquid biopsy testing could help physicians avoid severe side effects.
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Liquid biopsies analyze fragments of tumor DNA in blood
Northstar Select CH addresses another challenge in blood-based cancer testing. Liquid biopsies analyze fragments of tumor DNA circulating in the bloodstream. However, white blood cells can also release DNA that carries mutations unrelated to the tumor.
Studies suggest that roughly 25 per cent of patients show at least one actionable mutation that actually originates from blood cells. Meanwhile, those false signals may lead doctors to select treatments that do not target the cancer itself.
Northstar Select CH sequences white blood cell DNA for guideline-recommended genes. It also applies a proprietary machine-learning system to classify other gene alterations. Furthermore, the company reported more than 99 per cent positive and negative agreement in distinguishing tumor-derived mutations from non-tumor findings in a 114-patient study.
European Society for Medical Oncology guidelines recommend profiling white blood cells for certain tumor suppressor and DNA repair genes. Consequently, BillionToOne designed the add-on to align with those recommendations and reduce inappropriate treatment decisions.
Chief Medical Officer Gary Palmer said the company built the new applications around a core clinical question. He explained that oncologists want to know which therapy best fits each patient. Additionally, he stated that integrating pharmacogenomics and clonal hematopoiesis analysis into one workflow empowers doctors without adding operational complexity.
The company allows clinicians to order both add-ons at the same time as Northstar Select. The system incorporates the results directly into a single report. Furthermore, physicians can access tumor profiling, chemotherapy metabolism guidance, and mutation origin analysis from one blood sample.
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Multiple different diagnostic options
One promising area uses breath analysis to find chemical signatures linked to tumors. Breath Diagnostics Inc. has developed the OneBreath technology to capture and analyze volatile organic compounds in a patient’s breath.
This approach aims to flag early disease signals that might otherwise need invasive tests. Furthermore, the company has reported preliminary data showing patterns that distinguish cancer patients from healthy individuals.
Another startup, Gritstone Oncology, is working with blood-based immune profiling rather than traditional DNA sequencing. The company’s platform seeks to identify immune responses that correlate with early tumor presence.
In addition to diagnosis, researchers hope this method can guide personalized treatment choices. Meanwhile, the technology is still undergoing validation in clinical studies, with the goal of proving robust performance in real-world settings.
At the same time, Exact Sciences Corporation (NASDAQ: EXAS) has commercialized tests such as Cologuard and is expanding liquid biopsy offerings for multiple cancer types. The company also invests in research to improve sensitivity and accessibility of early detection tools.
Consequently, Exact Sciences collaborates with academic and healthcare partners to broaden screening reach across diverse populations.
Together, these innovators reflect a broader shift toward detection strategies that are easier for patients and more actionable for clinicians. Additionally, combining breath analysis with blood-based and immune-based technologies could provide a more complete picture of cancer biology in the future.
