#USA #Menlo Park #NHS #Medicare #Northstar Select

Recent Developments in Oncology Testing: Medicare Covers Northstar Select®

In a significant advancement for precision oncology, BillionToOne, a California-based molecular diagnostics firm, has announced that its innovative genomic profiling test, Northstar Select®, has received Medicare coverage approval. The company aims to make advanced cancer testing more accessible to patients, enabling better therapy selection for those battling advanced solid tumors.

Understanding the Test
Northstar Select® is designed as an ultra-sensitive liquid biopsy test that utilizes advanced next-generation sequencing (NGS) technology. It encompasses an 84-gene panel specifically for detecting circulating tumor DNA (ctDNA) alterations. This means it can help oncologists pinpoint crucial genomic changes that influence treatment decisions, providing an edge in the increasingly complex landscape of cancer therapy. Notably, its patented Quantitative Counting Template™ (QCT™) technology allows for accurate single-molecule detection, setting it apart from other non-invasive tests.

The process enables the identification of genetic modifications across 82 genes for SNVs/indels, along with additional findings related to copy number variations and fusions. By providing this level of detail, Northstar Select® ensures that healthcare providers can base their treatment recommendations on the most relevant and current genomic data.

Significance of Medicare Coverage
As of February 14, 2025, Medicare beneficiaries who meet specific eligibility criteria can access this vital testing. The coverage decision, made by Palmetto GBA—an administrative contractor responsible for managing the Molecular Diagnostics Services (MolDx) program—reinforces the importance of Northstar Select® in improving patient outcomes through personalized medicine.

Dr. Oguzhan Atay, co-founder and CEO of BillionToOne, highlighted that this move is crucial in making advanced precision oncology tools more accessible, especially to those facing severe cancer diagnoses. This approval represents not just a milestone for the company but a step forward in the healthcare industry's pursuit of tailored treatments that suit individual patient profiles.

The Validation Behind Northstar Select®
The approval process for Medicare coverage was rigorous, necessitating comprehensive evidence demonstrating the test's analytical and clinical validity. A significant aspect of the evaluation included a head-to-head study comparing Northstar Select® to other liquid biopsy tests, which showed that BillionToOne's offering was able to identify 51% more clinically actionable alterations, many of which were detectable at levels below the standard detection thresholds of its competitors. This finding underscores the superior sensitivity of Northstar Select®—a crucial factor in the treatment landscape where every detail matters.

Gary Palmer, Chief Medical Officer for Oncology at BillionToOne, underscored the test's unique advantages in oncology, noting that it significantly enhances oncologists' ability to make informed treatment decisions. By identifying more actionable genetic alterations, Northstar Select® can guide treatment strategies that have the potential to lead to better patient outcomes.

An Expanding Portfolio
BillionToOne’s focus extends beyound Northstar Select®. It also includes Northstar Response®, a methylation-based liquid biopsy developed for monitoring treatment responses in cancer patients. Together, these innovations in cancer diagnostics give healthcare professionals powerful tools to manage and monitor patient treatment effectively, without the need for invasive procedures.

As the landscape of genomic medicine continues to evolve, the integration of comprehensive liquid biopsy tests like Northstar Select® into routine clinical practice represents a major shift towards customized cancer care. This new coverage by Medicare paves the way for future developments in the field and signifies a commitment to ensuring patients have access to cutting-edge diagnostic tools.

For further details about Northstar Select® and other services by BillionToOne, interested parties can visit northstaronc.com.

About BillionToOne
Headquartered in Menlo Park, California, BillionToOne is committed to making molecular diagnostics effective, affordable, and universally accessible. The firm’s unique approach harnesses the power of single-molecule NGS technology, spearheading new standards in fluid-based testing for cancer and other complex diseases. With the mission of improving diagnostic accuracy and patient care, BillionToOne remains at the forefront of innovative diagnostic solutions.