Medical Device Daily

Polymer Technology Systems (PTS; Indianapolis) is launching globally what it called “the world's first direct low-density lipoprotein (LDL) cholesterol test” for use at the point of care, riding a trend toward healthcare self-management, which increasingly means self-monitoring.

While the product is ultimately planned to be offered over the counter (OTC), currently it is CLIA-waived, FDA-approved and reimbursed by the Centers for Medicare and Medicaid Services (CMS; Baltimore) for use by physicians, pharmacies and other healthcare providers. It must still go through FDA approvals before being offered OTC.

“The LDL [number] is the 'Holy Grail' of lipid testing, and that's simply because it is the bad cholesterol,” CEO Robert Huffstodt told Medical Device Daily. “That's why [physicians] are going to put you on a statin drug, and until our technology was available, there was nothing at point of care that would give you a direct reading.”

The standard is to calculate LDL via the Friedewald equation, which Huffstodt said has been used since the early 1970s. While that equation provides an approximate reading, he said the test is “not good if your [triglycerides] are too high or too low, and it requires fasting to be completely accurate.”

“We've made all that ancient history with this product,” he said, noting that POC testing is all about “bringing testing closer to the consumer, the patient.”

He said he fully expects this to be an OTC product eventually, but the typical marketing cycle begins with offering the devices in physicians' offices, followed by screening environments. The advantage to physicians of the LDL test will be the ability to take LDL and other cholesterol measurements throughout the day and get an immediate response, rather than having to see patients early in the morning after they have fasted overnight for 10 to 12 hours.

“And if there's demand – and we're pretty sure there will be – you take it to an over-the-counter product,” he said.

In addition, PTS has recently received 510(k) clearance from the FDA for a new HDL cholesterol test-strip technology to be marketed worldwide under the PTS Panels brand.

Founded in 1992, PTS is privately held. Its device used to test for a variety of things by using test strips – and which looks much like a typical glucose meter – is the CardioChek System, launched worldwide in 2003.

Huffstodt said that while the technology behind it was developed in-house, “it built on earlier technology for glucose testing,” with PTS expanding that concept to be used with different lipids and cholesterol.

Physicians use the direct LDL Test Strip with the portable CardioChek PA handheld analyzer. The direct LDL color-coded MEMo chip is placed into the meter, a test strip is inserted, and a drop of the patient's blood is applied to the strip.

In about two minutes, results appear on the analyzer as a numeric value that can be compared with standard guidelines to determine whether the patient is within recommended guidelines or may require cholesterol-lowering therapy.

Test strips can be used to measure total cholesterol, direct LDL cholesterol, HDL cholesterol, glucose, triglycerides, ketone and creatinine.

Huffstodt said of the CardioChek systems that there are currently “tens of thousands in use” in 60 countries, with about 25 million patients having been tested using the system. And abroad, that's not just in physician offices, but “all over the map,” he said, including the consumer level.

“We have some pretty big installed bases with doctors overseas – probably 10,000 systems and screening systems,” he said. “A big one would be the city of Taipei; a small one would be the U.S. Congress. We've done both of those.”

Those two entities use “hundreds of thousands of strips on very few meters,” he said.

Another important advantage to physicians is the fact that when a doctor orders a typical “full panel” on a patient, Medicare and other payors may only reimburse a certain number of those a year. It is at that point that the LDL test on the CardioChek system is “ideally suited,” because CMS is “more generous with single tests,” Huffstodt said.

Asked what he would like the impact of the LDL test to be, he said, “I would like to hear the doctor say, 'Run a direct.'”

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