A small laboratory in Arizona has brought to market a product the Cancer community is sorely in need of: a low-cost molecular test that can detect all forms of lung cancer at all stages of the disease. The firm, Tempe, Ariz.-based Global Cancer DX, last month introduced a primarily direct-to-consumer assay simply called The Lung Cancer Test. It retails for only $99 and is focused on groups at high risk for the disease, current and past smokers over the age of 50. That’s about 47 million people nationwide. The test is available in 45 states, 26 of which allow direct ordering by consumers without a physician’s order. Global Cancer Chief Executive Officer and founder Will Gartner—who previously developed a low-cost breast cancer test for another of his startups, Provista Life Sciences (now part of Provista Diagnostics)—is playing his cards close to the vest regarding this new assay. Claiming that a firm in China infringed on his breast cancer testing patent, he will only say that The Lung Cancer Test uses the enzyme-linked immunosorbent assay method and focuses on biomarkers relevant to detecting the disease. Global Cancer is also keeping the price of the test low due to Gartner’s previous work […]
A small laboratory in Arizona has brought to market a product the Cancer community is sorely in need of: a low-cost molecular test that can detect all forms of lung cancer at all stages of the disease.
The firm, Tempe, Ariz.-based Global Cancer DX, last month introduced a primarily direct-to-consumer assay simply called The Lung Cancer Test. It retails for only $99 and is focused on groups at high risk for the disease, current and past smokers over the age of 50. That’s about 47 million people nationwide. The test is available in 45 states, 26 of which allow direct ordering by consumers without a physician’s order.
Global Cancer Chief Executive Officer and founder Will Gartner—who previously developed a low-cost breast cancer test for another of his startups, Provista Life Sciences (now part of Provista Diagnostics)—is playing his cards close to the vest regarding this new assay. Claiming that a firm in China infringed on his breast cancer testing patent, he will only say that The Lung Cancer Test uses the enzyme-linked immunosorbent assay method and focuses on biomarkers relevant to detecting the disease.
Global Cancer is also keeping the price of the test low due to Gartner’s previous work trying to get payers to cover the breast cancer assay. “I just swore . . . I would never develop another test that would require medical insurance reimbursement,” he said.
The company has conducted four validation studies for The Lung Cancer Test, and the numbers are impressive: a 92 percent overall accuracy rate for detecting lung cancer, although false positives have been a relatively high 19 percent and false negatives register at a 15 percent rate. However, the data suggest it works at a consistently high rate detecting cancers even at the earliest stages of the disease.
Lung cancer has the highest death rates of all cancers in the United States, killing about 160,000 people a year, up 3.5 percent between 1999 and 2012, according to the American Lung Association. Although survival rates are relatively high when detected in the earliest stages of the disease, most patients are diagnosed only when they become symptomatic, at which point the cancer is usually at an advanced stage.
But perhaps more crucially, the Lung Cancer Test is able to detect small cell carcinomas at an overall 90 percent rate, including 67 percent at stage I and 100 percent at both stages II and III. There has been a lack of any test to detect small cell carcinoma, which kills at a higher rate than other forms of lung cancer.
Gartner said the lab has already received a variety of orders through the Internet from individual customers. His business plan predicts that Global Cancer will generate a substantial profit from the test by the end of next year.
Global Cancer is processing the assay at its own facility, with a turnaround time of 48 hours. It has a draw facility contract with Any Lab Now, which operates in Arizona and North Carolina. It is currently negotiating a pact with Medix Exams—which collects samples for disability and life insurers—to draw blood from patients in other states. The company is also getting feelers from national labs such as Quest Diagnostics and LabCorp, according to Gartner.
Gartner added that a variety of imaging companies—who do a significant business in lung cancer screening—have contacted his lab about the test.
“They can screen for cancer, and then do a CT scan, and know they’re finding growths,” he said. “They very strongly get the picture.”
Takeaway: A low-priced test may now be able to detect the single deadliest form of cancer, even in its earliest stages.
