OrbiSeq™ is a scalable precision healthcare platform that enables clinically actionable products across diagnosis, treatment, prevention, and healthy aging. Our lead product focuses on the non-invasive diagnosis of early-stage lung cancer. Future products will address additional diseases and conditions, improving patient outcomes while reducing healthcare costs.

Diagnosis

Lung cancer is the world’s deadliest cancer, killing more people than breast, prostate, and colorectal cancers combined, and one of the most expensive cancers to treat—primarily due to late diagnosis. It typically does not cause symptoms until later stages and remains the only major cancer without a routine screening test. Earlier diagnosis offers the greatest opportunity to improve patient outcomes while reducing healthcare costs.

The standard for lung cancer diagnosis is low-dose CT (LDCT). Every year, approximately 2 million Americans are found to have indeterminate pulmonary nodules (IPNs) that cannot be diagnosed from the initial LDCT. These patients are given two options. They can either undergo an invasive and expensive lung biopsy, which often has complications and may be inconclusive, or wait to see if the nodule changes over time—often through imaging surveillance for up to one year—knowing they might have lung cancer. There is no accurate, non-invasive way to diagnose IPNs when they are first detected.

Orbit Genomics’ lead product, OrbiSeq-L™, addresses this significant unmet clinical need. The simple blood test is the first test accurate enough to diagnose early-stage lung cancer in patients with IPNs and is currently advancing toward commercialization. OrbiSeq-L has the potential to improve patient outcomes, reduce unnecessary biopsies, and lower healthcare costs. The company was awarded an NIH/NCI Direct-to-Phase II SBIR Grant to develop the next generation of OrbiSeq-L, adding lung cancer subtyping while expanding its clinical utility.

Approximately 18–20 million Americans are considered high risk for lung cancer based on smoking history and are eligible for annual LDCT screening, yet screening rates remain below 10%. Insurers and clinicians recognize the need for a simple blood test to identify those most likely to benefit from screening. Building on the OrbiSeq-L platform, a future indication will focus on identifying individuals who should receive annual LDCT screening.

Prevention

Multi-cancer Risk Test

OrbiSeq-C, currently in development, is a single blood test designed to identify individuals at increased risk for multiple types of cancer. We have conducted pilot studies in medulloblastoma, breast, and lung cancers and identified markers for low-grade glioblastoma, high-grade glioblastoma, melanoma, ovarian, pancreatic, and prostate cancers. While the test can identify the presence of cancer, its primary goal is disease prevention. Individuals identified as being at increased risk can measure the effectiveness of interventions designed to reduce that risk through repeat testing.

Future products will be directed at other diseases and longevity.

Treatment

OrbiSeq can be applied to develop companion diagnostic (CDx) tests that identify patients most likely to benefit from a specific treatment. Proof of concept was demonstrated in atrial fibrillation and published in a peer-reviewed journal.

OrbiSeq can also be used to identify therapeutic targets.