“Our healthcare system is well-acquainted with the concept of making a profit from diagnostic testing, so it’s no surprise that some have found a way to do so,” he adds. “When tests are scarce, and their use is not directed by public health authorities, the price in the private sector is likely to rise.” “The key issue is the supply,” says Joshua Sharfstein, MD, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health. And this number of tests excludes simpler antigen tests, which you can do at home or at a testing center.Īmid the latest surge caused by the omicron variant, getting tested remains surprisingly difficult and time-consuming. “The limited supply, caused by suboptimal public health policymaking, creates this very attractive market opportunity for businesses to exploit.”īy early January, the Centers for Disease Control and Prevention had recorded more than 735 million COVID-19 tests during the pandemic, with almost 60 million coming up positive. Numerous other tests for sexually transmitted disease, infectious disease, and food tolerance are under development.“These companies are taking advantage of the limited supply of COVID tests to make money,” says Ge Bai, PhD, a professor of accounting at Johns Hopkins Carey Business School who has studied the price of COVID-19 tests. Six tests are available for sale in Europe including hCG, troponin, myoglobin, acetaminophen, salicylate and methanol. An hCG whole blood pregnancy test has received 510(k) clearance by the FDA for distribution in the U.S. Results are read on the NOWDiagnostics Lateral Flow Reader. The product line consists of more than 50 tests, which can be performed on a drop of blood. (Springdale, AR) has developed the ADEXUSDx brand, which was registered with the FDA in December 2014. The company presented data that compared patient test results from QDx with conventional laboratory instruments.

The device consists of a microfluidic cartridge and electrochemical biosensors. Researchers from DiaSys Diagnostics India presented a point of care device, named QDx Insta Lab, which can perform multiple laboratory tests on a few drops of blood obtained from a finger stick. Specificity is good enough to distinguish Ebola virus from closely related Marburg and Sudan viruses. This hybrid device has not yet been field tested. References and a photo of the connected chips can be seen at:Ī couple of other lab on a chip devices were presented at this summer’s 2015 AACC Annual Meeting and Clinical Lab Expo. Ebola RNA attached to microbeads is labeled with fluorescent probes, which are detected in the optofluidic chip.

A small magnet collects the microbeads, while extraneous material is washed away. If Ebola virus RNA is present it binds to complementary synthetic sequences attached to magnetic microbeads in the chip. A drop of extracted nucleic acid is pipetted into the microfluidic chip, where it undergoes the necessary preparatory steps to expose RNA. This device consists of a microfluidic chip for sample preparation connected to an optofluidic chip for virus detection. In this week’s NIH Director’s Blog, Francis Collins described a point of care test for detection of circulating Ebola virus.

This past week, two articles in the Wall Street Journal by John Carreyou (October 15 and 16) described the apparent failure of the much hyped Theranos Edison analyzer. However, Theranos’ woes does not mean that laboratory test innovation is stagnant. Below are three promising examples of miniaturized laboratory test devices which are not veiled in secrecy.

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