News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Scanadu is Preparing Consumer Self-Test Device for Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests

Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens

Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine.

The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices. (more…)

Consumers May Soon Have a Home Blood Collection Kit That Allows Them to Monitor and Quantify Damage to Their DNA

Exogen uses crowdfunding to both collect needed specimens and raise capital to pursue FDA clearance for its proposed medical laboratory test that would identify an individual’s damaged DNA

It might be coming soon to a pharmacy or other retail store near you: a medical laboratory test kit allows consumers to test themselves for damaged DNA. This bold new world for genetic testing is the vision of a new company in San Francisco called Exogen Biotechnology.

This startup business was co-founded by Sylvain Costes, Ph.D., a nuclear engineer who serves as Exogen’s Chief Executive Officer, and Jonathan Tang, Ph.D., a bioengineer. Their team is developing a blood test that will enable consumers to monitor their own DNA damage and take actions to reverse the damage. (more…)

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