Lung cancer is the leading cause of cancer death globally. In the United States alone, an estimated 158,080 deaths were attributable to lung and bronchus cancer in 2016. Lung cancer rates in the U. S. are declining, but approximately 90% of patients diagnosed with lung cancer will eventually die of the disease, making lung cancer the single most deadly solid tumor in the United States . It represents one in four cancer deaths in the U.S. (American Cancer Society) (Cancer facts & figures 2016)
While significant advancements have been made in early diagnosis of other common cancers, early diagnosis of lung cancer remains a challenge. It is the only major cancer without a routine screening exam. As a result, most patients with lung cancer are diagnosed when symptomatic, typically at an advanced stage of the disease, with extremely limited treatment options. There have been significant advances in computed tomography (CT) with spiral low-dose CTs (LDCTs) to assist in screening for early stage lung cancer. The National Lung Cancer Screening Trial (NLCST) a seminal study started in 2002 and completed in 2010, demonstrated a 20% reduction in mortality associated with LDCT screening, and the guidelines now endorse annual LDCT for those at high risk due to smoking. Cigarette smoking is linked to 90% of lung cancers in the United States. Heavy smokers and those who have smoked for decades are the most high-risk group. There are estimated to be at least nine million heavy smokers (over 50 years old and at least a 15-year history of smoking) who should have a spiral CT according to the US Preventative Task Force and published in the Annals of Internal Medicine,2013.
While the NLCST showed that early detection improved patient outcomes, patient adoption of the LDCT has been extremely low. It is estimated that only 10% of those eligible for LDCT actually get the test. While the exact reasons for the low adoption rates are not known, false positives are believed to contribute to the reluctance for some patients to get tested. LDCT has high false positives at rates estimated between 20-25%, requiring further invasive and expensive screening tests to confirm the results. This process can create confusion and angst for patients.
Orbit Genomics’ first product, OrbiSeq™-L, will aid in early diagnosis of lung cancer by identifying individuals at high risk for lung cancer through a simple blood test. In addition to the ~9 million high risk smokers and former smokers who are eligible for LDCT screening, there are another ~9 million Americans who are at moderate risk for lung cancer due to smoking. And, approximately 10% of lung cancer patients have never smoked or been exposed to second hand smoke. OrbiSeq™-L addresses both the smoking and non-smoking population.
The company’s second product will be a pan-cancer panel to assess risk for several types of cancer in a single test. We completed 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. The test not only measure individual disease risk for multiple cancers, but it can also be used to measure the effectiveness of lifestyle changes made to reduce risk through repetitive testing.