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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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…)

Swiss Researchers Developing a Smartphone-based Coagulation Test to Help Patients on Anticoagulation Therapy to Self-Test at Home

The device would save patients frequent trips to a hospital medical laboratory and automatically transmit coag test results to attending physicians

Researchers in Switzerland are putting coagulation testing together with a smartphone specifically to allow patients to do home self-testing. This is another example of how technology is getting closer to moving medical laboratory tests out of the core lab and into near-patient settings.

This groundbreaking work is being done by researchers at École Polytechnique Fédérale de Lausanne (EPFL) [Swiss Federal Institute of Technology]. They want to develop a smartphone device that enables patients to monitor their own anticoagulation therapy at home, according to a report published by Fiercemobilehealthcare.com. (more…)

Collaboration of Caltech Engineers and LeukoDX Produces Prototype Point-of-Care Device That Counts White Blood Cells in Minutes in the Patient’s Home

The science behind the device is an innovative detection assay of dyes that stain leukocytes so they will fluoresce and enable differentiation of white blood cell subtypes 

Over the last couple of years, medical laboratory technology developers have brought a number of FDA-approved point-of-care (POCT) and home self-tests to market.

These medical tests run the full spectrum. They include tests to detect HIV, malaria, pregnancy or male fertility, drug use or Hepatitis C. There are tests to monitor liver function, glucose in diabetics, cholesterol; and provide needle-free CBCs and genetic tests. (more…)

Hospitals Generally Charge Self-pay Patients Top Price for Care, but Some Providers Now Offer Deep Discounts for Patients Who Pay with Cash

Clinical laboratories and pathology groups may want to review the prices they charge insured patients versus uninsured patients

There is a certain irony in the fact that hospitals and other medical providers typically charge patients without health insurance as much as three times what they charge Medicare or an insured patient. This situation is getting increased media scrutiny, which is one reason why clinical laboratories and pathology groups may want to review their own policies for charging patients without health insurance.

One good study on prices charged to self-pay patients was conducted by Gerard Anderson, Ph.D.,  a health economist at the Johns Hopkins Bloomberg School of Public Health. His study was funded by the Henry J. Kaiser Family Foundation and published in the May-June 2007 journal Health Affairs.

Anderson analyzed 2004 hospital billing data. He concluded that the gap between rates charged self-pay and insured patients has grown substantially since the mid-1980s. “In the 1950s, the uninsured and poor were charged the lowest prices for medical services. Today they pay the highest prices…,” wrote Anderson, noting that self-pay charges often reflect the hospital’s “chargemaster” prices–the top prices used to negotiate discounts with insurers. (more…)

UA Research Will Accelerate Development of Clinical Laboratory Blood Test for Breast Cancer

Use of synthetic antibodies and a finger prick sample of blood could give clinical laboratories new tool to screen for breast cancer


A simple clinical pathology laboratory blood test for early detection of breast cancer may be just around the corner. At the University of Arkansas (UA), researchers are building a library of synthetic antibodies called affitoids that can be used to detect breast cancer in its earliest stage.

Researchers believe they are closing in on the creation of an assay that can rapidly validate proteins secreted by microscopic breast cancer cells. “We want to implement a rapid screen that is sensitive, highly accurate, non-invasive and inexpensive,” said Shannon Servoss, Ph.D., Assistant Professor of Chemical Engineering at UA. “Such a test would be easy to use and applicable to women of all ages, races and ethnicities,” she said. “Hopefully we will be able to make the test sensitive enough so that only a finger prick [specimen] is needed.”

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