Thread: Blood test to spot cancer gets big boost

Blood test to spot cancer gets big boost

J&J announces plans to help bring 'liquid biopsy' to the market

By MARILYNN MARCHIONE
The Associated Press
updated 1/3/2011 12:01:32 AM ET 2011-01-03T05:01:32

BOSTON — A blood test so sensitive that it can spot a single cancer cell lurking among a billion healthy ones is moving one step closer to being available at your doctor's office.

Boston scientists who invented the test and health care giant Johnson & Johnson will announce Monday that they are joining forces to bring it to market. Four big cancer centers also will start studies using the experimental test this year.

Stray cancer cells in the blood mean that a tumor has spread or is likely to, many doctors believe. A test that can capture such cells has the potential to transform care for many types of cancer, especially breast, prostate, colon and lung.

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..Initially, doctors want to use the test to try to predict what treatments would be best for each patient's tumor and find out quickly if they are working.

"This is like a liquid biopsy" that avoids painful tissue sampling and may give a better way to monitor patients than periodic imaging scans, said Dr. Daniel Haber, chief of Massachusetts General Hospital's cancer center and one of the test's inventors.

Ultimately, the test may offer a way to screen for cancer besides the mammograms, colonoscopies and other less-than-ideal methods used now.

"There's a lot of potential here, and that's why there's a lot of excitement," said Dr. Mark Kris, lung cancer chief at Memorial Sloan-Kettering Cancer Center in New York. He had no role in developing the test, but Sloan-Kettering is one of the sites that will study it this year.

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Many people have their cancers diagnosed through needle biopsies. These often do not provide enough of a sample to determine what genes or pathways control a tumor's growth. Or the sample may no longer be available by the time the patient gets sent to a specialist to decide what treatment to prescribe.

Doctors typically give a drug or radiation treatment and then do a CT scan two months later to look for tumor shrinkage. Some patients only live long enough to try one or two treatments, so a test that can gauge success sooner, by looking at cancer cells in the blood, could give patients more options.

AP
This undated image provided by PNAS Early Edition shows a circulating tumor cell cluster isolated using the HB-Chip from the blood of a patient with metastatic prostate cancer. "If you could find out quickly, 'this drug is working, stay on it,' or 'this drug is not working, try something else,' that would be huge," Haber said.

The only test on the market now to find tumor cells in blood — CellSearch, made by J&J's Veridex unit — just gives a cell count. It doesn't capture whole cells that doctors can analyze to choose treatments.

Interest in trying to collect these cells soared in 2007, after Haber and his colleagues published a study of Mass General's test. It is far more powerful than CellSearch and traps cells intact. It requires only a couple of teaspoons of blood and can be done repeatedly to monitor treatment or determine why a drug has stopped working and what to try next.

"That's what got the scientific community's interest," Kris said. Doctors can give a drug one day and sample blood the next day to see if the circulating tumor cells are gone, he explained.

The test uses a microchip that resembles a lab slide covered in 78,000 tiny posts, like bristles on a hairbrush. The posts are coated with antibodies that bind to tumor cells. When blood is forced across the chip, cells ping off the posts like balls in a pinball machine. The cancer cells stick, and stains make them glow so researchers can count and capture them for study.

The test can find one cancer cell in a billion or more healthy cells, said Mehmet Toner, a Harvard University bioengineer who helped design it. Researchers know this because they spiked blood samples with cancer cells and then searched for them with the chip.

Studies of the chip have been published in the journals Nature, the New England Journal of Medicine and Science Translational Medicine. It is the most promising of several dozen that companies and universities are rushing to develop to capture circulating tumor cells, said Bob McCormack, technology chief for Veridex.

The agreement announced Monday will have Veridex and J&J's Ortho Biotech Oncology unit work to improve the microchip, including trying a cheaper plastic to make it practical for mass production. No price goal has been set, a company official said, but the current CellSearch test costs several hundred dollars.

The companies will start a research center at Mass General and will have rights to license the test from the hospital, which holds the patents.

In a separate effort, Mass General, Sloan-Kettering, University of Texas M.D. Anderson Cancer Center in Houston and Dana-Farber Cancer Institute in Boston will start using the test this year. They are one of the "dream teams" sharing a $15 million grant from the Stand Up to Cancer telethon, run by the American Association for Cancer Research.

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Already, scientists have been surprised to find that more cancer patients harbor these stray cells than has been believed. In one study, the test was used on men thought to have cancer confined to the prostate, "but we found these cells in two-thirds of patients," Toner said.

This might mean that cancer cells enter the blood soon after a tumor starts, or that more cancers have already spread but are unseen by doctors.

Or it could mean something else entirely, because researchers have much to learn about these cells, said Dr. Minetta Liu, a breast cancer specialist at Georgetown University's Lombardi Comprehensive Cancer Center. She led a session on them at the recent San Antonio Breast Cancer Symposium and has been a paid speaker for Veridex. She hopes the cells will someday aid cancer screening.

"The dream is, a woman comes in for her mammogram and gets a tube of blood drawn," so doctors can look for cancer cells in her blood as well as tumors on the imaging exam, she said.

That's still far off, but Mass General's test already is letting doctors monitor patients without painful biopsies. Like Greg Vrettos, who suffered a collapsed lung from a biopsy in 2004, when he was diagnosed with lung cancer.

"It had spread to both lungs and they couldn't operate," said Vrettos, 63, a nonsmoker and retired electrical engineer from Durham, N.H. Tests from the biopsy showed that he was a good candidate for the drug Iressa, which he has taken ever since. He goes to Boston every three months for CT scans and the blood test.

"They could look at the number of cancer cells and see that it dropped over time. It corresponded with what the scans were showing," Vrettos said of doctors looking at his blood tests.

The test also showed when he had a setback last January and needed to have his treatment adjusted.

"I think it's going to be revolutionary," he said of the test.

http://www.msnbc.msn.com/id/40881967/ns/health-cancer/

But will Obamacare, more specifically Donald Berwyn, approve of this test?

If research and studies prove this works it will save Medicare and Medicaid a lot of money by catching cancer early when treatment is the most successful

Medicare pays for:

Preventive Services
Abdominal Aortic Aneurysm Screening
A one-time screening ultrasound for people at risk. Medicare only covers this screening if you get a referral for it as a result of your one-time "Welcome to Medicare" physical exam. Before January 1, 2011, you pay 20% of the Medicare-approved amount. Starting January 1, 2011, you pay nothing for the screening if the doctor accepts assignment.

Bone Mass Measurement
Helps to see if you are at risk for broken bones. This service is covered once every 24 months (more often if medically necessary) for people who have certain medical conditions or meet certain criteria. Before January 1, 2011, you pay 20% of the Medicare-approved amount, and the Part B deductible applies. Starting January 1, 2011, you pay nothing for this test if the doctor accepts assignment.

Cardiovascular Screenings
Helps detect conditions that may lead to a heart attack or stroke. This service is covered every 5 years to test your cholesterol, lipid, and triglyceride levels. No cost for the tests, but you generally have to pay 20% of the Medicare-approved amount for the doctor's visit.

Colon Cancer Screening (Colorectal)
Colorectal cancer is usually found in people age 50 or older, and the risk of getting it increases with age. Medicare covers colorectal screening tests to help find pre-cancerous polyps (growths in the colon) so they can be removed before they turn into cancer. Treatment works best when colorectal cancer is found early.

One or more of the following tests may be covered. Talk to your doctor.

Fecal Occult Blood Test—Once every 12 months if 50 or older. You pay nothing for the test, but you generally have to pay 20% of the Medicare-approved amount for the doctor’s visit.

Flexible Sigmoidoscopy—Generally, once every 48 months if 50 or older, or 120 months after a previous screening colonoscopy for those not at high risk. Before January 1, 2011, you pay 20% of the Medicare-approved amount at your doctor’s office, 25% of the Medicare-approved amount if you get it in an outpatient hospital setting or an ambulatory surgical center. Starting January 1, 2011, you pay nothing for this test if the doctor accepts assignment.

Colonoscopy—Generally, you can get this procedure once every 120 months, or 48 months after a previous flexible sigmoidoscopy. If your doctor says you’re at high risk, you can get it every 24 months. There’s no minimum age required for you to get a colonoscopy. If you get the procedure before January 1, 2011, you’ll pay no Part B deductable, plus 20% of the Medicare-approved amount at your doctor’s office or 25% of the Medicare-approved amount if you get it in an outpatient hospital setting or an ambulatory surgical center. If you get the procedure on or after January 1, 2011, you’ll pay nothing for the procedure if your doctor accepts assignment.
Barium Enema—Once every 48 months if 50 or older (high risk every 24 months) when used instead of a sigmoidoscopy or colonoscopy. You pay 20% of the Medicare approved amount for the doctor’s services. In a hospital outpatient setting, you also pay the hospital a copayment.

Diabetes Screenings
Checks for diabetes. These screenings are covered if you have any of the following risk factors: high blood pressure (hypertension), history of abnormal cholesterol and triglyceride levels (dyslipidemia), obesity, or a history of high blood sugar (glucose). Tests are also covered if you answer yes to two or more of the following questions:

Are you age 65 or older?
Are you overweight?
Do you have a family history of diabetes (parents, siblings)?
Do you have a history of gestational diabetes (diabetes during pregnancy), or did you deliver a baby weighing more than 9 pounds?

Based on the results of these tests, you may be eligible for up to two diabetes screenings every year. No cost for the test, but you generally have to pay 20% of the Medicare-approved amount for the doctor's visit.

Diabetes Self-Management Training
For people with diabetes. Your doctor or other health care provider must provide a written order. You pay 20% of the Medicare-approved amount, and the Part B deductible applies.

Flu Shots
Helps prevent influenza or flu virus. Generally covered once a flu season in the fall or winter. You need a flu shot for the current virus each year. No cost to you for the flu shot if the doctor or other health care provider accepts assignment for giving the shot. Note: Medicare Part B also covers administration of the H1N1 flu shot. You pay nothing if your doctor accepts assignment for giving the shot.

Glaucoma Tests
Helps find the eye disease glaucoma. Covered once every 12 months for people at high risk for glaucoma. You are considered high risk for glaucoma if you have diabetes, a family history of glaucoma, are African-American and age 50 or older, or are Hispanic and age 65 or older. An eye doctor who is legally authorized by the state must do the tests. You pay 20% of the Medicare-approved amount, and the Part B deductible applies for the doctor’s visit. In a hospital outpatient setting, you also pay the hospital a copayment.

Hepatitis B Shots
Helps protect people from getting Hepatitis B. This is covered for people at high or medium risk for Hepatitis B. Your risk for Hepatitis B increases if you have hemophilia, End-Stage Renal Disease (ESRD), or a condition that increases your risk for infection. Other factors may increase your risk for Hepatitis B, so check with your doctor. Before January 1, 2011, you pay 20% of the Medicare-approved amount, and the Part B deductible applies. Starting January 1, 2011, you pay nothing for the shot if the doctor accepts assignment.

HIV Screening
Medicare covers HIV screening for people with Medicare who are pregnant and people at increased risk for the infection, including anyone who asks for the test. Medicare covers this test once every 12 months or up to 3 times during a pregnancy. You pay nothing for the test, but you generally have to pay the doctor 20% of the Medicare approved amount for the doctor’s visit.

Breast Cancer Screening (Mammograms)
A type of X-ray to check women for breast cancer before they or their doctor may be able to find it. Medicare covers screening mammograms once every 12 months for all women with Medicare age 40 and older. Medicare covers one baseline mammogram for women between ages 35–39. Before January 1, 2011, you pay 20% of the Medicare-approved amount. Starting January 1, 2011, you pay nothing for the test if the doctor accepts assignment.

Medical Nutrition Therapy Services
Medicare may cover medical nutrition therapy and certain related services if you have diabetes or kidney disease, or you have had a kidney transplant in the last 36 months, and your doctor refers you for the service. Before January 1, 2011, you pay 20% of the Medicare-approved amount, and the Part B deductible applies. Starting January 1, 2011, you pay nothing for the test if the doctor accepts assignment.

Pap Tests and Pelvic Exams (includes clinical breast exam)
Checks for cervical, vaginal, and breast cancers. Medicare covers these screening tests once every 24 months, or once every 12 months for women at high risk, and for women of child-bearing age who have had an exam that indicated cancer or other abnormalities in the past 3 years. No cost to you for the Pap lab test. Before January 1, 2011, you pay 20% of the Medicare-approved amount for Pap test specimen collection, and pelvic and breast exams. Starting January 1, 2011, you pay nothing for Pap test specimen collection, and pelvic and breast exams if the doctor accepts assignment.

Physical Exam
Starting January 1, 2011, Medicare will cover two types of physical exams—one when you’re new to Medicare and one each year after that.

[b]One-time “Welcome to Medicareâ€