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Tag Archives: Pharmaceuticals/prescriptions/pharmacy

More progress, fewer barriers for PGx testing

January 2024—Sometimes even superb ideas can also turn out to be quite, well, bothersome. Zoom meetings. Bridal showers. Bike lanes. Parking apps. QR menu codes. And—if laboratories aren’t careful—the same can be true of pharmacogenomic testing. Just ask Ann Moyer, MD, PhD, associate professor, laboratory medicine and pathology, Mayo Clinic. When it comes to pharmacogenomic testing, laboratory medicine brings significant expertise to the table. But in clinical settings, physicians who prescribe the medications need to be familiar with how to use the test results. They also need to work with the lab to decide which tests, for which genes or gene-drug pairs, will be most helpful for their patients, she says. “Especially if you’re going to start incorporating clinical support alerts into the EHR,” adds Dr. Moyer, who was chair of (until Dec. 31; she is now advisor to) the CAP/ACMG Biochemical and Molecular Genetics Committee. “If the practice doesn’t actually want them, then you’re just going to end up annoying them.”

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Turning questions to answers in drug testing

July 2023—As she surveys the opioid epidemic in North America, Christine Snozek, PhD, D(ABCC), could be tempted to think that a ripped-from-the-headlines reality has landed in clinical laboratories as well as on TV crime dramas. With the number of opioid-related deaths increasing in recent years, particularly since the start of the pandemic, drug testing demands have increased for labs as well, says Dr. Snozek, codirector of clinical chemistry and support services and director of point of care and central processing at Mayo Clinic in Arizona. If only she could turn to the entertainment industry for a technology-based solution. “I wish we had CSI lab capabilities,” she says, referring to the long-running police procedural. “You could run a sample and find all the drugs known to man on one test. If they could go ahead and release that technology, that would be wonderful,” jokes Dr. Snozek. Given that laboratories are unlikely to take a meeting with network executives, Dr. Snozek and others in the field will have to look elsewhere.

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Highs, lows of tumor mutation burden testing

September 2022—It may not be the oldest story in the world, but in clinical laboratories it’s an oft-told tale: Tumor meets biomarker; drug meets companion diagnostic; both meet FDA approval; clinicians meet with patients offering new hope—and those in the lab are left trying to figure out how to make it all work. That story is playing out again in the realm of measuring tumor mutational burden. In mid-2020 the FDA approved pembrolizumab as a new treatment option in adult and pediatric patients with TMB-high (≥10 mutations/megabase) solid tumors, as determined by the FDA-approved FoundationOne CDx assay. “That doesn’t sound too controversial, right?” says Alain Borczuk, MD, vice chair of anatomic pathology and director of oncologic pathology, Northwell Health Cancer Institute. “It’s not the only way in, but it’s one of the ways in. If you’re arguing for your patient that this is the biomarker that makes them eligible for the drug, then the next questions will be, What was the number? And what was the test?” And it’s off to the races.

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Breast cancer breakthrough sparks HER2 quest

June 2022—The latest advance in breast cancer treatment is a big one—the promising antibody drug conjugate fam-trastuzumab deruxtecan-nxki, or T-DXd (Enhertu). The drug was granted break­through therapy designation this spring for patients with HER2-low metastatic breast cancer, and the drug and trial on which the decision was based were the focus of the plenary session at the ASCO annual meeting in early June. “This drug in particular is a variant of a drug we are all very familiar with—Herceptin, or trastuzumab,” says David Rimm, MD, PhD, the Anthony N. Brady professor of pathology, professor of medicine (oncology), director of the translational pathology and Yale pathology tissue services, and director of the physician scientist training program in pathology, Department of Pathology, Yale University School of Medicine. Also familiar: the IHC test to determine eligibility for the drug, a companion diagnostic developed decades ago. But that’s where easy familiarity ends.

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At NCI, on the trail of drug-induced liver injury

January 2020—When looking at a liver biopsy, always suspect there might be drug-induced liver injury. “But then try hard to prove there isn’t. It’s always a diagnosis of exclusion and pattern evaluation,” says David E. Kleiner, MD, PhD, reference pathologist for the Drug-Induced Liver Injury Network. In that role, he pieces together clues that point to a drug having injured a liver—or not. Drug-induced liver injury is rare, and few pathologists see it. “The incidence is between one in 100,000 and one in a million, depending on what survey you read,” Dr. Kleiner says.

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TDM to the rescue in biologics boom

July 2019—In the early, heady days of biologic therapies, use of these drugs resembled a common military tactic of the Civil War: charge and retreat, charge and retreat, charge and retreat. The approach, though modern at the time, often proved disastrous. Jeffry Katz, MD, recalls the excitement that greeted the arrival of anti-tumor necrosis factor-α agents, starting with infliximab (Remicade) in 1998. “What we used to do is we would give patients a drug, and we would wait for them to get sicker,” says Dr. Katz, medical director, inflammatory bowel diseases, University Hospitals Cleveland Medical Center, and professor of medicine, Case Western Reserve University School of Medicine.

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Pharma strives to aid companion diagnostics

May 2015—M. Elizabeth H. Hammond, MD, is no mind reader. But approach her at a conference or meeting, and she has a pretty good idea what you’re going to ask her. “I was the chair for the 2007 and 2013 ASCO-CAP HER2 guideline, and since that time, the most common question I get from individuals is, ‘How do you know the guideline is making any difference?’” says Dr. Hammond, who is a professor of pathology and adjunct professor of internal medicine at the University of Utah School of Medicine and a consulting pathologist, Intermountain Healthcare.

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