True Detection

Anpac Bio — a medtech company building its U.S. headquarters in Sacramento — makes a bold claim to revolutionize cancer screening

Back Longreads Dec 6, 2016 By Russell Nichols

For years, Chris Yu didn’t know he was colorblind. He found out when he was 20, on a path to become a medical doctor like many in his family. During a physical exam, he learned he didn’t see red and green the way other people do. It was devastating. Growing up in Shanghai, he dreamed of following in the footsteps of his mother, uncle and grandparents, who were all in the medical field. But in the 1970s, being colorblind in China precluded him from being a doctor, so he changed his focus to physics.

These days, you’ll likely see Dr. Chris Yu’s name next to words like “breakthrough” and “game-changer.” He is the CEO of Anpac Bio-Medical Science Company, a Shanghai biotech firm regarded worldwide for its early cancer screening, detection and diagnostic technology. The company made headlines a year ago for choosing Sacramento instead of Silicon Valley for its U.S. headquarters, and the welcome couldn’t have been warmer. Mayor Kevin Johnson, in his final State of the City address, broke the news.

“If you’re not familiar with this company, don’t worry, you will be,” Johnson told a packed Crest Theatre. “Dr. Chris Yu has developed a breakthrough cancer screening technique that uses a simple blood test instead of invasive biopsies to diagnose cancer. And this new technique is amazingly accurate. It not only detects the presence of cancer, but it pinpoints the exact location.”

“Symptoms may manifest in different areas than where the cancer originated. Half the battle for doctors is knowing where to look.”Drisha Leggitt, VP of U.S business development, Anpac Bio

The crowd burst into applause as Yu made his way through hugs and handshakes to the stage, a sudden River City superhero. To clarify, the technology pinpoints the system within the body (digestive, respiratory, reproductive, etc.) that shows signs of precancerous conditions or cancer cells, usually at the earliest stages with a 75 to 90 percent accuracy rate, according to Anpac Bio officials.

“Symptoms may manifest in different areas than where the cancer originated,” says Drisha Leggitt, a cancer survivor and Anpac Bio’s vice president for U.S. business development. “Half the battle for doctors is knowing where to look.”

But Anpac Bio’s major innovation is not about where, but when. Catching cancer in the earliest stages has been Yu’s goal since the company launched in 2010. With so much medical research focused on treatment and imaging, he set his sights on early detection as the key to prevention. His ideas were unconventional. He faced resistance all the way. But next year, Anpac Bio should wrap its first clinical trial in the U.S., a study that could help the company gain FDA approval and potentially revolutionize cancer screening.

“A very well-respected Sacramento oncology surgeon told us, ‘The last greatest, most disruptive cancer screening technology was the Pap smear 40 years ago,’” Leggitt says. “This has that same capability.” *

‘BAD THINGS TURN INTO GOOD THINGS’

In 1989, Yu received his doctorate from Penn State in physics, a degree that propelled him into the world of diagnostics. Semiconductors. Integrated circuits. Transducers. This was his expertise through the 1990s, as he loaded his resume with leadership positions at three Fortune 500 companies, including Motorola, before launching his own tech startups in the 2000s. He has more than 100 patents to his name.

But Yu’s dream to be a doctor never left him. In 2008 he contacted his cousin, a researcher at the Yale School of Medicine who would co-found Anpac Bio. It dawned on Yu that he could apply what he learned in the technology industry to advance cancer diagnostic research. He never would’ve become a physicist if he hadn’t been diagnosed colorblind. But Yu, who is protective of the details behind his R&D team’s patented technology and algorithms, says it was this open-minded, cross-disciplinary approach that led to Anpac Bio’s breakthrough.

Dr. Chris Yu and Drisha Leggitt were at Sacramento State for its Global Entrepreneurship Week in November. Anpac is working with the college’s science and business departments to offer internships, mentorship and networking opportunities for students. Leggitt says they also hope to bring exemplary students as guests to the World Nobel Prize Laureate Summit. (photo by Terrance Duffy)

“We started with a blank piece of paper to avoid the older technology and the older way of thinking,” he says. “If I stayed in medical school, I wouldn’t be able to do this work. Bad things turn into good things.”

Anpac Bio’s “cancer differentiation analysis” technology requires about the same amount of blood as a cholesterol test. The CDA machine processes the blood and produces a report with a range of values to determine a patient’s health. In CDA reports, a value below 40 is healthy or normal range; 40 to 50 means medical professionals should monitor the patient because this could be genetic predisposition, remission, gene mutation or other precancerous conditions; above 50 means there’s a good chance cancer cells exist and further investigation and/or treatment is in order. This medical test screens 16 cancers at one time, but Leggitt says the technology is not meant to displace screening tests such as colonoscopies or mammograms. The CDA machine could serve as an additional tool for medical professionals, especially in regards to early detection.

“What doctors have been trained to do is cure the disease,” Leggitt says. “But cancer is a hundred different diseases. Leukemia is different than brain tumors, which are different than prostate cancer. But my boss said, ‘If we catch it early, we can beat all of these — all 100.’”

WHAT’S THE CATCH?

Why is early detection so crucial? The earlier doctors catch the disease, the better the chance of survival. If the CDA machine identifies a precancerous condition early (e.g. cirrhosis of the liver), the patient can be directed to get treatment or medication, and modify their lifestyle to prevent the condition from becoming a full-blown cancer, Leggitt says. This also applies to early-stage cancers.

For about $300, a patient could get tested with Anpac Bio’s technology, a simple procedure that can be done on anyone, any age and with no side effects, Leggitt says.

Take breast cancer, for example. More women are diagnosed with breast cancer than any other type. In 2016, more than 40,400 U.S. women were expected to die from breast cancer, but overall death rates have been dropping since 1989, according to the American Cancer Society. Survival rates go down for women diagnosed in later stages.

The standard screening test for breast cancer is a mammogram, which is recommended for women age 40 or older, depending on various risk factors. But the technology has its limitations. For example, false-negative results -— where the cancer is present but the X-ray doesn’t find it — happen in 1 in 5 screenings, according to the ACS.

For about $300, a patient could get tested with Anpac Bio’s technology, a simple procedure that can be done on anyone, any age with no side effects, Leggitt says. In addition, she adds that the test will save insurance companies millions of dollars because it costs more to treat a cancer patient with a late-stage disease. Based on results from its six active sites in China, Anpac Bio touts that its machine can identify early-stage breast cancer at an unprecedented 82 percent rate of accuracy.

Not everyone is buying those figures. Some experts said they never heard of the company. Others refused to go on record, but said the company lacked information or published papers showing the technology actually works.

Leggitt recalls a talk she gave on the technology, where an attendee (who she chose not to name) interrupted her presentation. “He said, ‘You can’t possibly have those numbers! Those numbers don’t exist!’” she says. “Truly disruptive innovation can really shake some cages.”

With technology out of China, some people don’t trust the data, she says. Yu hired Leggitt for her credibility — not just her PR savvy but also her history as a Stage IV cancer patient. She’s been through radiation and surgeries and now, nearly 23 years in remission this February, she speaks from a personal place. Her passion helped convince Yu that coming to Sacramento would be the right play and his esteemed reputation in China would inspire other companies to follow suit.

“I told him, ‘If we select Sacramento, we will be part of the Sacramento welcome wagon,’” Leggitt says. “‘We would help create a pipeline that allows Chinese life science companies to have a supportive market and help launch them in the U.S.’”

Dr. Chris Yu (far right) with Sir Richard John Roberts (center), 1993 winner of the Nobel Prize in Physiology or Medicine, and theoretical physicist Dr. Sheldon L. Glashow (far left), winner of the 1979 Nobel Prize in Physics, at the World Nobel Prize Laureate Summit held in Chengdu, China last September. (Photo courtesy of Anpac Bio)

As promising as it sounded, Yu wanted to base his company in Silicon Valley. That was the plan. But, as he knows firsthand, plans can change.

SCOUTING REPORT

On Nov. 3, 2015, Yu attended his first-ever basketball game. He went with Mayor Johnson and brought some of his Anpac Bio team to see the Sacramento Kings play. Yu doesn’t remember if the Kings won or lost (they lost), but he loved the atmosphere. Before that trip, Sacramento wasn’t even on his radar.

But Johnson and Barry Broome, CEO of the Greater Sacramento Area Economic Council, gave Yu the VIP treatment. They set up meetings for him at all the major medical institutions in the region. They connected him with economic leaders. They wined and dined him, and convinced him to see the River City in a new light.

Broome didn’t lean heavily on his old standby pitch that Sacramento is more affordable than the Bay Area. Instead, he went another route, highlighting the region’s health systems, pool of local talent and proximity to the Silicon Valley.

“You’ve got to sell your strengths,” Broome says. “Dignity Health and the medical school at UC Davis were real strengths. This is a company that has a chance to redefine thew region’s reputation.”

The effort paid off, with Anpac Bio becoming Broome’s first major win for GSAEC, which launched in February 2015 replacing the Sacramento Area Commerce and Trade Organization. But he admits that whenever big companies end up in Sacramento, credit usually goes to a local champion on the inside — Leggitt, in this case.

“Doubters are usually experts. They are the establishment. Every single major innovation always encountered skepticism and doubters at the beginning.” Dr. Chris Yu, CEO, Anpac Bio

Later in November 2015, when Yu and Leggitt met with Johnson and Broome for the final pitch, Yu said, “Mr. Mayor, I want to thank you for all of your support, good wishes and hard work. I’ve decided to make Sacramento our U.S. headquarters.”

TRIAL BY BLOOD

To this point, Anpac Bio leaders assert that they have completed about 30,000 cases in China with most results covering breast and prostate cancers. They have also had success in identifying cancers in the lungs, liver, stomach and esophagus, and plan to add brain, cervical and others to the list of cancers the CDA machine can detect.

The company now has more than 100 employees worldwide. By the end of 2017, Yu hopes to take Anpac Bio public with an IPO in Asia. Eventually, Yu plans to set up collaborations with Sutter Health, Kaiser Permanente and UC Davis. But the first order of business is to conduct a clinical trial and research studies with U.S. medical partners like Dignity Health of Greater Sacramento.

“You’ve got to understand, this is the first technology of this magnitude in the U.S.,” says Laurie Harting, chief of operations for Dignity Health and a board member for Greater Sacramento.

In October, Anpac Bio assembled and calibrated its first U.S.-based CDA devices by processing 100 random blood samples — donated by volunteer patients, families and employees. Anpac Bio received them blindly, not knowing whether the samples where cancerous or healthy, and conducted CDA tests on each. The CDA results were then compared to the results generated through traditional testing, to see if they matched.

“It’s more like a closed-book examination,” Yu says. “They’re going to score us to see how well we do. That’s what the FDA wants to see.”

Getting FDA approval — which has an uncertain timeline, even if a clinical trial proves successful — is key because it would allow the CDA tests to be covered by insurance. Then the company can go public in the U.S. and the naysayers will have nothing to say. As he powers forward with short-term plans to create 250 biomedical jobs and long-term plans to build a 50,000-square-foot research and manufacturing campus in Sacramento, Yu is unfazed by any lingering skepticism.

“This is a dream for all scientists around the world to solve the case of early detection problems,” Yu says. “We encountered skeptics who said it was nearly impossible. Doubters are usually experts. They are the establishment. Every single major innovation always encountered skepticism and doubters at the beginning. Reflecting on the journey, everything becomes clear.”

* Editor’s note: This quote has been amended to clarify that the comment originally came from an oncology surgeon.

Post new comment

493813710231108 » If you have a visual disability, please type the numbers two one three three into the box. Your submission will be promptly reviewed by a validation service and sent to the site administrators.
By proving you are not a machine, you help us prevent spam and keep the site secure.