Pathology Today
Jan. 22, 2015

Top legal minds against FDA's proposal to regulate lab tests
A new legal whitepaper authored by two of America's most prominent lawyers argues that the U.S. Food and Drug Administration's plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful. More

Mayo fights stricter oversight of lab tests
Star Tribune
Proposed federal rules to require new government approval of certain tests developed in medical schools and private business laboratories have drawn cries of protest from the Mayo Clinic. The proposed rules would for the first time make labs designing the tests prove their effectiveness to the U.S. Food and Drug Administration (FDA). Test developers also would have to formally report to the government problems that occur with the tests after they become available.More

Stakeholders ask FDA to educate labs on agency thinking, terminology before finalizing LDT guidance
During the second day of a public workshop on the regulation of laboratory-developed tests (LDTs), industry stakeholders asked the U.S. Food and Drug Administration to produce several publications to better explain how they can meet the agency's requirements. Specifically, workshop attendees requested FDA publish a paper explaining how it gauges the risk a test poses to public health; put out a document outlining the areas where the agency will harmonize its regulations with existing requirements under the Centers for Medicare & Medicaid Services; and issue another, revised LDT draft guidance before publishing a final version.More

Do some clinical lab companies oversell prenatal genetic screening tests?
Dark Daily
In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry. What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline "Oversold prenatal tests spur some to choose abortions."More

83 percent of physicians are resistant to use EHRs for clinical communications
HIT Consultant
Eighty-three percent of physicians expressed frustration using EHRs to support clinical communications due to poor EHR interoperability, limited EHR messaging capabilities and poor usability that makes it difficult to find relevant clinical data, according to a recent study by Spyglass Consulting Group. The report entitled Point of Care Communications for Physicians 2014 based on 100 doctors working in hospital‐based and ambulatory environments nationwide reveals physicians are universally (96 percent) using smartphones as their primary device to support clinical communications. More

Portable 'blood test in a box' to give instant diagnoses
For most of us, a blood test begins with a needle, a syringe and the promise it will all be over quickly. But at the back end, testing blood often requires transporting the vial to a clinic, a range of laboratory equipment and trained clinicians and doctors to get an accurate result. The whole process can take days, and in some cases even weeks. But imagine if you could put the whole laboratory into a portable unit that delivered a reading immediately?More

New data points to lung cancer biomarker potential for sputum microRNAs
Amid ever-increasing interest in using microRNAs as biomarkers, researchers from the University of Maryland published a new study suggesting that the small, non-coding RNAs may help in differentiating patients with early-stage lung cancer from those with non-malignant lung nodules. Non-small cell lung cancer remains the leading cause of cancer deaths in the U.S., killing an estimated 160,000 Americans last year.More

GI needle biopsies do not spread cancer, study suggests
Needle biopsies of the pancreas are not associated with an increased risk for death in patients with pancreatic cancer, according to a retrospective study published online January 9 in Gut. The findings reinforce the safety of ultrasound-guided fine-needle aspiration (EUS-FNA), say the study investigators, who are all from the Mayo Clinic.More

How to reduce risk during inpatient transitions
Healthcare Finance
Good communication between hospitalists and primary care physicians at the time of discharge is critical to patient safety and to the reduction of risk. Historically, this communication has been "one-way" in the form of a discharge summary. Studies have shown that "[F]ollowing hospital discharges nearly half (49 percent) of hospitalized patients experience at least one medical error in medication continuity, diagnostic workup, or test follow-up." More