Approvals mark ‘tip of the iceberg’ for PD-L1 testing

What the FDA giveth, the FDA may taketh away.

On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

Aside from offering patients another, less toxic treatment option, the FDA action seemed to portend a big boost to the surgical pathologist’s role in lung cancer care, says Philip T. Cagle, MD. He is medical director of pulmonary pathology at Houston Methodist Hospital and editor in chief of Archives of Pathology & Laboratory Medicine.

“Almost all of the lung cancer patients, one would expect, would be potential candidates for immunotherapy. They may get some other therapy first, but eventually they would be candidates for this,” he says. “The test is immunohistochemistry, and the good news about that is pathologists are already mostly set up to do IHC.…And they can bill and get reimbursed for immunohistochemistry, in contrast to a lot of the issues we have with molecular tests. There are many positives for pathologists, surgical pathologists, and cytopathologists to do this test themselves rather than simply collect tissue for the molecular lab. That’s the good news.”

My lead item in November’s “Put It on the Board” section of CAP TODAY. Read the whole shebang to find out some of the not-so-good news from the FDA.

Analyze this: data shines within and without

At PAML patient service centers, patients fresh from a blood draw may spot a kiosk that asks, “How was your experience today?”

Responding is as easy as pushing one of four buttons with facial expressions that range from a broad smile to a major frown. The kiosk’s manufacturer, HappyOrNot, says about 20 percent of customers across a spectrum of industries will stop to register their level of satisfaction. For PAML, the rate is averaging 60 percent, and the results are transmitted wirelessly, says Rosalee Allan, senior vice president and chief operations officer at PAML (Pathology Associates Medical Laboratories, Spokane, Wash.).

“This sends us a dynamic report and we can tell by the hour what’s going on at our patient service center,” Allan says. The question patients are asked to answer can be changed on the fly to, for example, “How was your wait today?” during especially busy times of the day.

“We can find out what the dissatisfier is at this patient service center between three and five in the afternoon,” Allan says.

How Allan and her colleagues at PAML used this information to unravel the patient service center puzzle—more on that later—illustrates just one way that laboratories are using the power of data, properly analyzed, to achieve objectives. There are, experts say, two broad categories of ends to which labs today are applying analytics. In the first class sits laboratory operations. Here, the use of analytics is geared toward reducing unneeded test ordering or improving patient experience, turnaround times, and client service.

The second, broader category can be dubbed health system analytics. Some enterprising lab professionals are looking beyond the traditional confines of the laboratory to investigate how optimal use of analytics could prompt timelier patient interventions and avert costly episodes of care or help slash inappropriate use of high-priced medications.

My cover story in the November issue of CAP TODAY. Read the whole shebang.

Neuropathologist Dr. Omalu in spotlight at CAP ’15

Bennet Omalu, MD, MBA, MPH, who gave the spotlight event speech at CAP ’15 earlier this month, says he met retired Pittsburgh Steeler Mike Webster before conducting the 2002 autopsy that would lead to the first diagnosis of chronic traumatic encephalopathy in a National Football League player.

“I met him on TV,” Dr. Omalu says. “All the channels were talking about this great NFL player who died suddenly, and talking about him in very derogatory ways. Many NFL players, when they retire, they don’t handle their money well. They become destitute and bankrupt.”

To the Nigerian-born Dr. Omalu, fresh from completing his neuropathology fellowship at the University of Pittsburgh Medical Center, football players scrambling across the field in headgear “looked like extraterrestrials.”

The lead item in this month’s “Put It on the Board.” Read the whole shebang.

Case closed: discrepant results at multiple sites

As hospitals are brought under single health systems, laboratory leaders are faced with the task of ensuring that their clinical lab results are comparable among various sites and instruments. But some have had more opportunity than most to investigate the mischief afforded by variations in instruments, reagents, and more.

Dina N. Greene, PhD, found herself in that position. She worked for four years at Kaiser Permanente Northern California, where she served as a clinical chemistry consultant for its 21 hospital laboratories in the area and directed hemoglobinopathy and myeloma testing for the system’s regional laboratory.

“This is an increasing kind of problem with consolidation. As different universities acquire more hospitals and as hospital systems acquire other hospitals, it’s going to be an increasing challenge,” says Dr. Greene, now associate director of chemistry at the University of Washington Medical Center. She also is assistant professor in the Department of Laboratory Medicine at UW, which she joined in December 2014.

“You have to standardize your equipment—that’s a fundamental part of this. Without standardizing the equipment, you just have so much more opportunity for wildly different results, especially if everything is going into the same electronic medical record,” Dr. Greene says.

Another feature from the October CAP TODAY. Read the whole shebang.

Flexible ordering may unravel pay snags for respiratory panels

The advantages of molecular respiratory viral panels are accompanied by a challenge for laboratories that find it difficult to secure payment for testing that can cost hundreds of dollars, depending on the number of pathogens involved.

These respiratory panels can create complications for laboratories that must juggle several platforms to meet clinician needs, spare patients from unnecessary out-of-pocket costs, and responsibly use lab resources. A newly cleared flexible respiratory testing panel could offer laboratories another approach.

My cover story in the October edition of CAP TODAY. Read the whole shebang.

Roche buys ‘sample in, susceptibility out’ technology

Roche has signed a definitive agreement to acquire Los Gatos, Calif.-based GeneWeave BioSciences, a privately held company focused on molecular clinical microbiology diagnostic solutions.

The acquisition provides Roche with GeneWeave’s Smarticles technology, which quickly identifies multidrug-resistant organisms and assesses antimicrobial susceptibility directly from clinical samples without the need for traditional enrichment, culture, or sample preparation processes. GeneWeave’s first system in development is the vivoDx, a fully automated, random-access system designed to meet the needs of laboratories addressing MDRO detection and antibiotic therapy guidance. The technology, marketed as enabling a “sample in, susceptibility out” testing paradigm, is being evaluated at multiple sites across the U.S.

My latest in the “Put It on the Board” section of CAP TODAY. Read the whole shebang.

Integrating AP and radiology, inch by inch

Two major specialties serve all of health care as the foundation for diagnosis. Now efforts to align pathology and radiology again appear to be picking up steam. As payment shifts to so-called value-based care and as medical record systems may challenge successful test interpretation, many experts seek a clear integration of these two specialties.

So begins my cover story in September edition of CAP TODAY. Read the whole shebang.

To meet TAT goals, Vanderbilt builds ED lab

In a move expected to help meet accreditation standards on testing turnaround times for stroke and chest pain patients, Vanderbilt University Medical Center’s emergency department will gets its own satellite laboratory this month. The 333-square-foot space—dubbed “the nest” for its small size—comes after years of struggle with the turnaround time demands for certification as a Joint Commission Comprehensive Stroke Center and accreditation as a Chest Pain Center by the Society of Cardiovascular Patient Care.

My lede for this item in the “Put It on the Board” section. Read the whole shebang.

Lab studies new steps in urine and anemia screening

Despite the demonstrated value of implementing reflex testing algorithms to improve patient care and avert wasteful spending, the road from conceptual understanding to plan-in-action can be rocky.

A pathologist at one academic medical center recently talked about his experience with reflex testing algorithms in the areas of urine screening and preoperative anemia screening. His story illustrates the barriers to change as well as the enviable outcomes that could potentially be achieved.

My lede. Read the whole shebang.

Pay is up in Medicare proposal, but final picture unknown

After years of reading the latest news from the CMS with dread, pathologists and independent laboratories have some reason for revelry this summer as the agency’s proposed physician fee schedule offers an overall uptick in Medicare payment for 2016. Yet it is the final physician fee schedule, due in November, that will tell whether pathologists feel grateful toward the CMS when Thanksgiving rolls around.

My lede. Read the whole shebang.

AMP puts a cost — and value — to sequencing procedures

Amid excitement about the groundbreaking work of unlocking the human genome’s secrets to speed diagnosis and target oncologic treatment comes the unpleasant reality that much of this labor now goes unpaid. Getting the American Medical Association’s editorial panel to publish nearly two dozen new genomics-related CPT codes for molecular pathology was a vital step, as was having those codes accepted in the Medicare clinical laboratory fee schedule.

In CAP TODAY’s “Put It on the Board” section this month. Read the whole shebang.