OrbiSeq can be applied to develop products that diagnose, treat and help prevent complex diseases, including cancer, heart disease and neurological diseases. Our initial focus is on more accurate and earlier cancer diagnosis.  Future products will address other diseases and conditions. All products will improve patient outcomes.

Diagnosis

Lung cancer is the world’s deadliest cancer, killing more people than the next three cancers combined – colon, breast and prostate. It typically doesn’t have symptoms until later stages, and it is the only major cancer without a routine screening test.  As a result, too often, it is not diagnosed until late, deadly stages.

The standard for lung cancer diagnosis is low-dose CT, LDCT. However, every year approximately 1.6-2 million Americans have LDCT scans with indeterminate pulmonary nodules that cannot be diagnosed from the initial LDCT. These patients are given two options. They can either undergo an invasive and expensive lung biopsy, that often has complications and may be inconclusive or wait and see if the nodule changes over time, typically one year, knowing they might have cancer. There is a huge unmet need for a non-invasive alternative to biopsies for quickly diagnosing indeterminate pulmonary nodules.

Orbit Genomics’ first product, OrbiSeq™-L addresses this huge unmet need. The simple blood test demonstrated unparalleled accuracy in diagnosing patients with indeterminate pulmonary nodules and the company is preparing for non-interventional studies for product launch. OrbiSeq-L will improve patient outcomes, reduce unnecessary biopsies and save lives. The company was awarded a Direct to Phase II SBIR Grant to develop the second version of the lung cancer test that also provides subtyping information, expanding its use and further reducing unnecessary biopsies.

There are 18-20 million Americans who are considered high-risk for lung cancer based on smoking history and eligible for annual LDCT screening (American Cancer Society). Compliance is extremely low with best estimates below 10%. Insurers and clinicians agree there is a huge need for a pre-screening test to determine who should receive annual LDCT. OrbiSeq-L’s second indication will be a screening test to determine who should receive an annual LDCT.

Prevention

Multi-cancer Risk Test

OrbiSeq-C, currently in development, is a single blood test to assess risk for several types of cancer. We conducted pilot studies for medulloblastoma, breast and lung cancers. We have identified markers for low-grade glioblastoma, high-grade glioblastoma, melanoma, ovarian, prostate and pancreatic cancers. While the test will diagnose cancer, its goal is disease prevention. Individuals with elevated disease risk can measure the effectiveness of changes made to reduce their risk through repetitive testing.

Future products will be directed at other diseases and longevity.

Treatment

OrbiSeq can be applied to develop companion diagnostic tests, CDx, to determine if a patient will respond to a particular treatment. Proof of concept was demonstrated in atrial fibrillation in a peer reviewed publication.  

OrbiSeq can also be used to identify therapeutic targets.

Products directed at treating diseases will be pursued with other companies or research centers.