20⁄20 test shows promise in ‘billion-dollar’ market

Friday, July 28, 2006

It’s a long shot, say some, but 20⁄20 Gene Systems Inc. may be onto an innovative way for doctors and hospitals to detect early risk of lung cancer.

The test licensed by the Rockville biotech locates five proteins or biomarkers in blood samples that signal the body’s response to early tumors. The test predicted pre-cancer in about 85 percent of 102 blood samples drawn from patients one to five years before tumors were detected by radiation, in a study published earlier this month.

President and CEO of 20⁄20 Jonathan Cohen said that if results hold up in a planned study of more than 1,000 samples, the company would prepare to move toward marketing the test.

Cohen said the test could be a new way to find lung cancer long before tumor cells show up in X-rays or CT scans, the standards of lung diagnostics. He said developing the cancer test is a high priority at the company.

‘‘It is big market, probably a billion dollar market,” said Cohen. ‘‘Our goal is to discovery and develop the first new blood test for cancer since the 1970’s,” when the prostate-specific antigen test was introduced.

The private 20⁄20 has been financed by more than $1 million in government grants and about $3 million in private equity in the past five years and product sales of $500,000 million annually. Also, last week, 20⁄20 and the University of Kentucky received a joint $175,000 grant from the National Institutes of Health to further develop the lung cancer test.

Claire Mullins, spokeswoman for the American Lung Association of Maryland, said, ‘‘This is an innovative test and could be a significant leap forward in the detection of lung cancer, which is often diagnosed in the latter stages, making it difficult to treat.”

Although Jim Barrett, senior analyst for New Enterprise Associates in Baltimore, praised the idea of the new cancer test, he cautioned that detecting cancer ‘‘is not a simple story.” He said, ‘‘the problem is always defining the population to screen. There is lots of work up required to determine if a patient has cancer.” An National Cancer Institute study published in December showed that many false positive test results from chest X-rays cause needless extra tests.

Waiting to confirm an early detection test is stressful, said Barrett, such as when someone needs a biopsy to confirm an indication of breast cancer from a mammogram. He said that even with an 85 percent accuracy in the 20⁄20 test, 15 percent is still questionable. ‘‘A false positive is really as bad as a false negative.”

Also hopeful for a better test is Peter G. Shields, a principle investigator at Georgetown University Medical Center for the NCI’s National Lung Screening Trial of more than 50,000 patients, comparing detecting lung cancer: spiral computed tomography and standard chest X-ray.

Shields said that 20⁄20 possibly ‘‘overstates” its early research on the company Web site. But he said that many scientists are trying to find a better early test, because ‘‘CT scans can’t distinguish early cancers very well from noncancerous lesions, it is not a good screening test.” Neither chest X-rays nor spiral CT scans have been shown to reduce a person’s chance of dying from lung cancer.

According to NCI about 170,000 people in the United States are diagnosed with lung cancer each year and most are diagnosed after their disease is advanced. Nearly 90 percent die within two years.

Cohen argues that catching lung cancer early will increase survival rates considerably through earlier treatments. ‘‘This is a new phase of bio-markers that makes sense. The challenge is to find the needle in the haystack—the small number of lung cells that are abnormal. We use the body’s immune force multiplier, its antibodies.” Any smokers found to be positive, he said, would then get an X-ray or CT scan, he added.

‘‘By detecting the cancer earlier, chances of responding to treatment would increase, as would the survival rate,” said Mullins.

Shields said that research on other alternatives or methods to use along with CT scans includes other early lung cancer tests include better radiology tests, sputum and different blood tests.

The study of the 20⁄20-licensed test is in the July issue of the Journal of Thoracic Oncology, led by Li Zhong of the University of Kentucky. Last year, Zhong and colleagues at UK’s Chandler Medical Center analyzed 212 candidate proteins as markers and eventually narrowed them down to the five most predictive cancer-associated antibody proteins. Using these proteins, they were able to achieve over 90 percent accuracy in spotting cancerous and cancer-free samples from patients.

But the road to an early cancer test is very difficult said Shields.

In 1999, researchers at the University of Maryland Baltimore developed a test that located an enzyme telomerase that is associated with uncontrolled growth of tumors in the lung. However that test never made it out of the laboratory.

A pre-cancer protein-sensing device to detect by Protiveris Inc., a biotool making company formerly in Rockville, may also be dead. [Business Gazette, July 8, 2005] According to records at the association MdBio Inc., Protiveris, the 2001 Maryland Incubator Company of the Year, is out of business.

In more preliminary studies, ChromoTrax, a biotech startup in Frederick, is developing DNA probes to detect ‘‘precursor cancer cells.”