BillionToOne

BillionToOne is a precision diagnostics company headquartered in Menlo Park, California, United States, founded in 2016 by Dr. Oguzhan Atay and Dr. David Tsao. The company describes itself as a precision diagnostics company building powerful molecular diagnostics by quantifying biology, aiming to improve disease detection by counting molecules with a proprietary molecular counting platform. Its stated mission is "to remove the fear of the unknown by providing accurate, fast, and accessible molecular diagnostics." The core of the company's technology is Quantitative Counting Templates (QCTs™), which underpins its single-molecule next-generation sequencing (smNGS) platform. According to the company, this platform can directly measure rare disease-causing DNA fragments or molecules at the single base-pair level, thereby quantifying minute variants using cell-free DNA (cfDNA). BillionToOne applies this technology in two major areas: noninvasive prenatal screening and liquid biopsy. In prenatal, the company offers Unity Complete® (also called UNITY Complete), which it describes as the first noninvasive prenatal test (NIPT) that uses cfDNA from a single maternal blood sample to assess the risk of fetal recessive genetic disorders and chromosomal aneuploidies from 9 weeks of gestation onward. The company states that Unity identifies about three times as many affected pregnancies as traditional screening, without the need for a partner sample. Earlier prenatal products include the UNITY Fetal Risk™ Screen and the UNITY Fetal Antigen™ test. In oncology, BillionToOne offers Northstar Select® and Northstar Response®, described as complementary pan-cancer liquid biopsy tests that can guide treatment selection and enable real-time monitoring of treatment response. The company states that Northstar Select is the most sensitive liquid biopsy for treatment selection, finding about 50% more clinically actionable variants than other ctDNA tests, while Northstar Response can track changes in tumor burden down to a tumor fraction of 0.01%, without the need for a tissue sample. The newer Northstar Origin test is used to help identify tissue of origin. The company has grown from a research-stage startup into a commercial-stage molecular diagnostics company, obtaining CLIA certification in 2019 and expanding its laboratory facilities. It has completed multiple rounds of venture financing, including a $15 million Series A, a $55 million Series B, and a $125 million Series C. BillionToOne remains a privately held company headquartered in Menlo Park, California.

BillionToOne was founded in 2016 in Menlo Park, California, with a mission to improve healthcare through ultra-high-resolution disease detection. According to the company's own milestones, it began with "half a bench" at the StartX incubator. In its founding and early R&D phase (2016–2018), the company received an NIH grant for the first single-gene NIPT clinical study with Baylor University and transitioned to its first independent lab with six employees. During this period the first QCTs were synthesized and visualized in gel electrophoresis. In 2019 the company reached market validation and closed a $15M Series A funding round, secured CLIA certification, and transitioned from a research startup to a commercial-stage molecular diagnostics company. It launched the first UNITY test, processed its first commercial patient sample, and made its market debut at the ACOG Conference. During 2020–2021, BillionToOne focused on commercial launch and scale. It launched the UNITY Fetal Risk™ Screen, described as the first and only prenatal test that can assess fetal risk for common recessive conditions using only a maternal blood sample, addressing a significant gap in the traditional NIPT market. It closed a $55M Series B to accelerate commercial growth and received its first UNITY Complete sample. In 2022–2023 the company emphasized rigor and clinical validation. It closed a $125M Series C and demonstrated technical leadership through CAP Accreditation and landmark data published in Genetics in Medicine and the American Journal of Hematology. These studies, plus a large-scale evaluation in Prenatal Diagnosis, confirmed the high accuracy of single-gene NIPT in the general pregnancy population. This rigor supported the launch of the UNITY Fetal Antigen™ test and a Phase 3 clinical trial collaboration with Johnson & Johnson. The company also expanded its state-of-the-art lab facility by 90,000 sq ft. In 2023, BillionToOne expanded into oncology, launching Northstar Select® and Northstar Response®, applying its proprietary smNGS platform to liquid biopsy for therapy selection and treatment monitoring. The company later launched Northstar Origin, a liquid biopsy test to help identify tissue of origin. As of its published materials, BillionToOne continues to operate from Menlo Park, California, as a privately held precision diagnostics company.

• 2026

  Launched Northstar Origin, a new liquid biopsy test to help identify tissue of origin.

• 2023

  Launched Northstar Select® and Northstar Response®, applying the proprietary smNGS platform to liquid biopsy; expanded lab facility by 90,000 sq ft.

• 2022

  Closed a $125M Series C and demonstrated technical leadership through CAP Accreditation and landmark data in Genetics in Medicine and the American Journal of Hematology.

• 2021

  Closed a $55M Series B to accelerate commercial growth; received the first UNITY Complete sample.

• 2020

  Launched UNITY Fetal Risk™ Screen, the first and only prenatal test that can assess fetal risk for common recessive conditions using only a maternal blood sample.

• 2019

  Closed a $15M Series A funding round and secured CLIA certification; launched the first UNITY test and processed the first commercial patient sample.

• 2018

  Received an NIH grant for the first single-gene NIPT clinical study with Baylor University and transitioned to its first independent lab with six employees.

• 2016

  Founded in Menlo Park with a mission to improve healthcare through ultra-high-resolution disease detection, starting with 'half a bench' at the StartX incubator.

Precision diagnostics company using a proprietary molecular counting platform (QCTs™ / smNGS) to deliver accurate, fast, and accessible molecular diagnostics in prenatal screening and liquid biopsy.

• Unity Complete®

  The first non-invasive prenatal test (NIPT) that uses cfDNA to assess fetal risk for recessive conditions and aneuploidy from a single maternal blood sample at 9+ weeks.

• UNITY Fetal Risk™ Screen

  The first and only prenatal test that can assess fetal risk for common recessive conditions using only a maternal blood sample.

• UNITY Fetal Antigen™

  A prenatal test launched following clinical validation of single-gene NIPT.

• Northstar Select®

  A pan-cancer liquid biopsy test for therapy selection, described as the most sensitive liquid biopsy for therapy selection, uncovering ~50% more clinically actionable alterations than other ctDNA tests.

• Northstar Response®

  A pan-cancer liquid biopsy test for treatment response monitoring, tracking tumor burden changes down to 0.01% tumor fraction without requiring tissue.

• Northstar Origin

  A liquid biopsy test launched to help identify tissue of origin.

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