Medical Device Daily

Biomerica (Newport Beach, California) has added a new diabetes test to its arsenal of diagnostic tests for labs to evaluate patients for the chronic disease, one that many experts say is increasing at epidemic speed.

The new blood test will measure levels of C-peptide. The company said that C-peptide levels in blood are about five to six times greater than insulin levels and are more stable.

According to the American Diabetes Association (ADA; Alexandria, Virginia) C-peptide is a “connecting peptide,“ or a substance the pancreas releases into the bloodstream in equal amounts to insulin. The ADA said that measuring the level of C-peptide “shows how much insulin the body is making.“

While other companies, notably Abbott Diagnostics (Abbott Park, Illinois), offer C-peptide tests, Biomerica did not until now. However, the company does offer an islet cell autoantibody test (Isletest-ICA), insulin autoantibody test (Isletest-IAA) and GAD Autoantibody (Isletest-GAD).

“The C-peptide [test] is more of today's problem [with diabetes]; the other three we have are more [for] problems down the road,“ Biomerica President Fran Capitanio told Medical Device Daily.

The C-peptide test is designed to allow clinicians to differentiate between Type 1 and Type 2 diabetes. It also is used to indicate the need for a patient to progress to insulin therapy in Type 2 diabetes. It is essentially intended for patients who already have been diagnosed with diabetes to monitor their condition on an ongoing basis, Capitanio said.

C-peptide also is used to determine the cause of hypoglycemia, or low blood sugar, and to monitor the recovery of a patient after the removal of an insulin-producing tumor of the pancreas, the company said.

It also noted a recent study published in the Journal of the National Cancer Institute that linked elevated levels of C-peptide with an increased risk of colorectal cancer in men with diabetes.

“Our new C-peptide test is a substantial product addition to our current diabetic line of tests which help detect the onset of diabetes,“ Biomerica CEO Zackary Irani said in a statement. “The introduction of this product to our already existing customer base should not only result in increased sales, but should enhance Biomerica's presence in the clinical laboratory diabetes market.“

The test is administered at a clinical lab, Capitanio said, rather than in a physician's office. He said that having the C-peptide test will allow Biomerica to become more competitive by offering the test to laboratories. Because the test is not new, it will be covered by insurers.

“[W]e can [now] say that we've got more of a package of diabetes tests than just an individual test,“ Capitanio said. And he said that kind of “package“ is exactly what laboratories are looking for.

With the well-publicized growing epidemic of obesity and diabetes in the U.S and elsewhere, the demand for such tests is only expected to increase. “Biomerica is focusing on diabetes as one of its areas of focus, so we will have other tests coming down the road, and this is just part of that,“ Capitanio said.

Biomerica also offers rapid visual tests that can be used at home or in the physician's office. Among those are EZ Detect Fecal Occult Blood Test, EZ-PSA One-step PSA (prostate-specific antigen) test and EZ-HP One-Step H. pylori Test, as well as ovulation tests and pregnancy tests.

The company's clinical laboratory tests include those for thyroid testing, ulcer testing, calcium metabolism testing, anemia products tests for allergies and pituitary testing.

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