Irvine-based Laboratory for Advanced Medicine Inc. isn’t pursuing a magic-bullet immunotherapy drug to cure all cancers yet, but it sure is in growth mode.
The company’s groundbreaking IvyGene technology is a noninvasive blood test that could detect cancer.
“We focus on early cancer diagnosis,” said Chairman and Chief Executive Shu Li. “We want to cause a paradigm shift to treating cancer early. If you discover your cancer is in stage one, your recovery rate is 80% [versus] 5% if it’s stage four.”
LAM moved its headquarters from West Lafayette, Ind., to accommodate growth with the launch of IvyGene. Its new two-story, 10,000-square-foot office at 9950 Research Drive off the 5 Freeway at Lake Forest Boulevard includes a next-generation sequencing lab for research and development and a CLIA/CAP-certified lab.
General Manager and Vice President of Finance Justin Li said the company employs roughly 80 people, about 10 in Orange County. It plans to add 15 to 20 employees at the new headquarters.
Diagnostic Tool
Shu Li said the ability to identify specific cancers using minimally invasive tools can improve diagnosis and prognosis.
IvyGene uses advanced DNA sequencing methods to identify methylation, which differentiate tumors and normal tissues at specific target sites.
He said most cancer diagnostics tests look for mutation markers, which can “tell you if you have the propensity for getting a certain cancer but really cannot tell you if you’ve got cancer or not.”
LAM said it’s validated IvyGene for testing breast, colon, liver and lung cancers. It will continue to add to the list as it validates other cancers.
The test for the four cancers meets Food and Drug Administration requirement to be marketed as a laboratory-developed product designed, manufactured and used in a single lab.
The test’s sensitivity is approximately 86% for patients with clinically confirmed breast, colon, liver or lung cancers and who aren’t undergoing treatment, according to its website. The company said the test isn’t classified as a cancer screening but can identify cancer presence and give “quantifiable information about disease presence.” The test also can’t detect metastasis and is currently not covered by insurance.
Justin Li said that in addition to the pan-cancer test, the company has a liver cancer test proceeding through an FDA application.
Entrepreneur-Investor
Shu Li said he’s been an entrepreneur since the early 2000s, when he founded Newport Beach-based Jazz Semiconductor Inc. The company was acquired by Acquicor Technology Inc. in 2007 for $260 million in cash. He founded and serves as chairman of Irvine-based angel investment firm J&J Investments Worldwide Ltd., which founded ventures including WA Health Center (Nasdaq: KANG), Cellular BioMedicine Group (Nasdaq: CBMG), Global Health Investments and CAS Health Holdings, and is chairman of Yuge.com. Shu Li helped secure LAM’s technology from the University of California-San Diego. He’s a member of the Committee of 100 Chinese-Americans and the elite 1,000 of China.
He founded LAM last year. The company is listed in the portfolio of J&J Investments, of which Justin Li is a partner. Shu didn’t comment on if he’s related to Justin.
LAM has two additional locations in the U.S., its old facility in Indiana, a marketing office in Dallas, and four sites in China, according to Justin Li. A facility at Purdue Research Park, a network of four research parks less than two miles north of Purdue University’s West Lafayette campus, is roughly 10,000 square feet with various lab and office spaces, he said.
US-China-Europe
Justin Li said that with the addition of its Irvine facility, doctors will have two locations they can send blood samples to for testing.
LAM China is based in Beijing and led by Chief Executive Gary Gu, also a partner at J&J Investments.
Shu said the company wants to offer affordable cancer tests for average Americans, “with a simple, easy and non-invasive blood test [with a] three- to five-business-day turnaround time.”
He said the company has largely stayed under the radar and only unveiled itself because “it’s ready now … I really feel that with the launch of our product and the beginning our new Irvine headquarters, it really signifies LAM moving into the light and becoming a household name.”
The company plans to grow its presence in the U.S. and China, and eventually stretch to Europe.
Shu Li said LAM came to OC because it conveniently sits between San Diego—home to the largest genome sequencing company, Illumina Inc.—and Los Angeles County. “We are first a biotech company, and anytime you touch DNA sequencing, you want to be in this area.”
