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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Johnson & Johnson Investing to Learn How to Predict or Prevent Disease; Studies Could Lead to Clinical Laboratory Tests that Detect Disease Earlier and More Accurately

COPD and gestational diabetes research are the subject of two new projects aimed at intercepting diseases prior to onset and identifying preventive treatments

Can new insights into the human genome make it possible to diagnose disease much earlier—even before symptoms can be observed? Multiple research programs are targeting this possibility. One example is being conducted by Johnson & Johnson (J&J). The American multinational medical-device company wants to leverage recent developments in genetics, data analysis, and its worldwide partnerships, in an attempt to answer two profound questions:

• Can the earliest signals of disease be identified; and

• What treatments will assist researchers who are trying to prevent diseases?

To pursue these two goals, Johnson & Johnson (NYSE: JNJ) is expanding its existing research project into disease prediction and prevention, which currently involves 24 global partners, according to an Associated Press March story. (more…)

Exact Sciences Sues Humana Over Cologuard Coverage in Spat over How Insurer Reimburses for This Clinical Laboratory Test

Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states

Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.

Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.

Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.

They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)

Genetic Tests and Precision Medicine Start to Win Acceptance by Some Payers; Pathologists and Clinical Laboratories Have Opportunity as Advisors

UnitedHealthcare to cover Foundation Medicine’s comprehensive genomic profiling assay for solid tumors, but Medicare still reluctant to reimburse for genetic tests

Studies showing success of targeted therapies in cancer care may be having an influence on the decisions by certain health insurers to reimburse clinical laboratories to reimburse for certain genetic tests.

One example that press reports cite is how last December UnitedHealthcare began reimbursing for a certain genetic test for patients with a particular lung cancer, according to a statement from Foundation Medicine (NASDAQ:FMI). Based in Cambridge, Massachusetts, Foundation Medicine describes itself as “a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer.” (more…)

More Companies Pay for Employees to Have Genetic Tests in a Trend That Brings More Lab Test Volume to Medical Laboratories

As tests explore genetic markers related to excessive weight gain, and breast and ovarian cancer, companies as well as employees are seeing returns on investment and participation

In a development that is auspicious for medical laboratories, more genetic tests are making their way into more corporate health benefit plans. Big brands—from Aetna to Visa—are partnering with personalized health companies and clinical lab companies doing genetic testing as they support tests to help employees head-off health risks.

Employers’ sponsorship of genetic testing is a trend that could become more common, noted Fortune. But human resources and benefits experts say the offerings are still uncommon. There are also unresolved issues, such as when genetic test results are inconclusive or questionable.

For medical laboratories, the companies’ genetic testing benefits could prompt more test orders from healthcare consumers. Based on the results of their genetic tests, people might decide to make lifestyle changes, work toward prevention of chronic conditions, and take further tests to assess progress. (more…)

Researchers at Howard Hughes Medical Institute Develop Blood Test That Reveals a Patient’s Viral History; Could Reduce Unnecessary Clinical Laboratory Testing

The VirScan test gives doctors insight into a patient’s lifetime exposure to viruses and thus may be developed into a useful medical laboratory test

Scientists and pathologists are learning that blood is like a time capsule, holding precious information about exposure to viruses over the years—chickenpox at five, mononucleosis at 18, flu at 40. You get the idea.

Now, researchers at Howard Hughes Medical Institute (HHMI)  have found a way to tap that entire data stream, so to speak. An inexpensive blood test, they say, reveals every virus that has passed through the body over time.

New Discoveries Could Lead to a Useful Clinical Laboratory Test

The testing method, called VirScan by researchers, is an efficient alternative to current medical laboratory tests that test for specific viruses one at a time, according to an HHMI news statement about the new technology. (more…)

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