A new blood test by Roche Diagnostics (Indianapolis), designed to help physicians manage their patients’ postmenopausal osteoporosis, has received clearance from the FDA.

The test, called the Elecsys N-MID Osteocalcin test, determines the amount of osteocalcin, a protein found in the bone and in blood serum, which is an indicator of bone formation.

Roche said that for osteoporosis such as that afflicting Cherrie Burch, a 49-year-old woman diagnosed six years ago with low bone mass and taking a weekly biphosphonate, a blood test that can help her and her physician manage her osteoporosis more closely is key to disease management.

“Right now, I can only get a bone scan once every two years because of the insurance reimbursement and because it takes that long for the scan to see changes in bone formation through that type of test. I’m diligent about taking my biphosphonate, but it would be nice to see results more frequently,” she said.

She added: “Osteoporosis is very prevalent in my family, and I want to do what I can now in order to avoid fracturing a bone in the future.”

Lori LeRoy, a spokeswoman for Roche, told Diagnostics & Imaging Week that the blood test is not meant to replace the bone scan, but is instead meant to be an adjunct to it. The reason is that the test only indicates how well a therapeutic drug is working in bone formation.

“Osteoporosis is a serious, widespread and growing public health threat. The National Osteoporosis Foundation welcomes any new FDA cleared diagnostic options that will help patients address this all too prevalent disease,” said Judith Cranford, executive director of the National Osteo-porosis Foundation (NOH; Washington).

Regular monitoring has shown that it can improve a patient’s compliance with their therapy. A recent study on the impact of monitoring on adherence and persistence with treatment for postmenopausal osteoporosis showed that members of the group that was tested at three-month intervals increased their adherence to therapy by 57% and stayed on their therapy for 25% longer compared to the group with no monitoring, according to Roche.

According to the NOH, osteoporosis and low bone mass currently affects approximately 44 million women and men in the U.S., or 55% of all people aged 50 and over. By 2010, the number could increase by another 7 million.

The U.S. Department of Health and Human Services estimates that 1.5 million people suffer from an osteoporotic-related fracture each year and that one out of every two women over 50 will have an osteoporosis-related fracture in their lifetime.

Patients tested with the Roche Diagnostics Elecsys N-MID Osteocalcin need to have their blood drawn in the physician’s office or at a laboratory, and it typically takes one to two days for the results.

LeRoy said that the company has “several bone formation and osteoporosis markers,” which is one reason it decided to add another to the portfolio. She added that the market is a large one.

As part of its bone marker portfolio, Roche also offers the Elecsys Beta-CrossLaps test, a bone resorption marker, which monitors the efficacy of medications that slow or stop the natural process that dissolves bone tissue given to postmenopausal osteoporatic women. Using the Elecsys Beta-CrossLaps test, physicians can check the efficacy of treatment as early as three months after its introduction.

Roche Diagnostics also has the Elecsys PTH test, which determines intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.

The Elecsys Osteocalcin N-MID test should be available for testing of postmenopausal women with osteoporosis by year-end, the company said.