TOP NEWS

JULY 2024

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

  • Mayo pathologists create and test their own AI algorithms

    July 2024—A Mayo Clinic project is “democratizing artificial intelligence,” its leaders say, by enabling pathologists with varying levels of AI expertise—most of whom had never before participated in an AI project—to create and implement algorithms.

  • Using LEAP, Saudi laboratory attains accreditation

    July 2024—Earlier this year the laboratory at King Salman Armed Forces Hospital joined more than 120 other Saudi labs in achieving CAP accreditation. And it did so with a boost from LEAP. The 665-bed hospital needed to adopt standards for nearly all technical specialties and comply with more than 1,000 CAP requirements.

Image Credits: [do_widget id=enhancedtextwidget-12].

Video Spotlight

Coming in the July Issue

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

CAP TODAY Recommends

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

    Read More »

  • Clinical Lab 2.0 honors laboratory team excellence

    Clinical Lab 2.0, a Project Santa Fe Foundation initiative, released a proclamation during Medical Laboratory Professionals Week, April 14–20, to recognize and celebrate the roles of laboratory medicine and pathology in the field of medicine “as we transition from the business of volume to the business of value” in the delivery of integrated health care. Read the full proclamation here. Clinical Lab 2.0 was established to provide thought leadership and help develop the evidence base for the valuation of clinical laboratory services in the next era of global health care.

Image Credits: [do_widget id=enhancedtextwidget-12].

REGISTER NOW

  • Register for our upcoming webinar

    Genomic profile availability impact on NSCLC patient outcomes in real world study and daily practice
    UPDATE: Thursday, Aug. 22, 2024, 1:00–2:00 PM ET

    Webinar presenters Melina Marmarelis, MD, MSCE, and Salvatore Fortunato Priore, MD, PhD, will discuss a real-world study cohort utilizing electronic health records to assess the impact of the availability of genomic profiles on guiding first-line therapy and patient outcomes. They found that the availability of molecular genotyping results before first-line therapy was associated with significantly better overall survival, and that concurrent tissue and plasma testing was associated with higher odds of availability of results before first-line therapy.

    Read More »

  • Register for our Upcoming Webinar

    Tuesday, August 13, 2024, 1:00 PM–2:00 PM ET

    Webinar presenter Jerald Radich, MD, Professor, University of Washington School of Medicine, Member Clinical Research Division, Kurt Enslein Endowed Chair, Fred Hutchinson Cancer Research Center will discuss the new NCI program in precision medicine (“myeloMATCH”), especially the groundbreaking rapid genetic testing using the NCI Myeloid NGS Assay. This webinar will help you identify the implications of rapid (<72 hour) cytogenetic, flow cytometry, and NGS mutation testing on enabling expeditious patient assignment to particular myeloMATCH clinical trials based on matching their risk group and genetic lesions to available target therapies.

Image Credits: [do_widget id=enhancedtextwidget-12].

AMP Case Reports

JULY 2024

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

  • Mayo pathologists create and test their own AI algorithms

    July 2024—A Mayo Clinic project is “democratizing artificial intelligence,” its leaders say, by enabling pathologists with varying levels of AI expertise—most of whom had never before participated in an AI project—to create and implement algorithms.

  • Using LEAP, Saudi laboratory attains accreditation

    July 2024—Earlier this year the laboratory at King Salman Armed Forces Hospital joined more than 120 other Saudi labs in achieving CAP accreditation. And it did so with a boost from LEAP. The 665-bed hospital needed to adopt standards for nearly all technical specialties and comply with more than 1,000 CAP requirements.

Image Credits: [do_widget id=enhancedtextwidget-12].

Video Spotlight

Coming in the July Issue

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

CAP TODAY Recommends

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

    Read More »

  • Clinical Lab 2.0 honors laboratory team excellence

    Clinical Lab 2.0, a Project Santa Fe Foundation initiative, released a proclamation during Medical Laboratory Professionals Week, April 14–20, to recognize and celebrate the roles of laboratory medicine and pathology in the field of medicine “as we transition from the business of volume to the business of value” in the delivery of integrated health care. Read the full proclamation here. Clinical Lab 2.0 was established to provide thought leadership and help develop the evidence base for the valuation of clinical laboratory services in the next era of global health care.

Image Credits: [do_widget id=enhancedtextwidget-12].

REGISTER NOW

  • Register for our upcoming webinar

    Genomic profile availability impact on NSCLC patient outcomes in real world study and daily practice
    UPDATE: Thursday, Aug. 22, 2024, 1:00–2:00 PM ET

    Webinar presenters Melina Marmarelis, MD, MSCE, and Salvatore Fortunato Priore, MD, PhD, will discuss a real-world study cohort utilizing electronic health records to assess the impact of the availability of genomic profiles on guiding first-line therapy and patient outcomes. They found that the availability of molecular genotyping results before first-line therapy was associated with significantly better overall survival, and that concurrent tissue and plasma testing was associated with higher odds of availability of results before first-line therapy.

    Read More »

  • Register for our Upcoming Webinar

    Tuesday, August 13, 2024, 1:00 PM–2:00 PM ET

    Webinar presenter Jerald Radich, MD, Professor, University of Washington School of Medicine, Member Clinical Research Division, Kurt Enslein Endowed Chair, Fred Hutchinson Cancer Research Center will discuss the new NCI program in precision medicine (“myeloMATCH”), especially the groundbreaking rapid genetic testing using the NCI Myeloid NGS Assay. This webinar will help you identify the implications of rapid (<72 hour) cytogenetic, flow cytometry, and NGS mutation testing on enabling expeditious patient assignment to particular myeloMATCH clinical trials based on matching their risk group and genetic lesions to available target therapies.

Image Credits: [do_widget id=enhancedtextwidget-12].

AMP Case Reports

JULY 2024

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

  • Mayo pathologists create and test their own AI algorithms

    July 2024—A Mayo Clinic project is “democratizing artificial intelligence,” its leaders say, by enabling pathologists with varying levels of AI expertise—most of whom had never before participated in an AI project—to create and implement algorithms.

  • Using LEAP, Saudi laboratory attains accreditation

    July 2024—Earlier this year the laboratory at King Salman Armed Forces Hospital joined more than 120 other Saudi labs in achieving CAP accreditation. And it did so with a boost from LEAP. The 665-bed hospital needed to adopt standards for nearly all technical specialties and comply with more than 1,000 CAP requirements.

Image Credits: [do_widget id=enhancedtextwidget-12].

Video Spotlight

Coming in the July Issue

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

CAP TODAY Recommends

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

    Read More »

  • Clinical Lab 2.0 honors laboratory team excellence

    Clinical Lab 2.0, a Project Santa Fe Foundation initiative, released a proclamation during Medical Laboratory Professionals Week, April 14–20, to recognize and celebrate the roles of laboratory medicine and pathology in the field of medicine “as we transition from the business of volume to the business of value” in the delivery of integrated health care. Read the full proclamation here. Clinical Lab 2.0 was established to provide thought leadership and help develop the evidence base for the valuation of clinical laboratory services in the next era of global health care.

Image Credits: [do_widget id=enhancedtextwidget-12].

REGISTER NOW

  • Register for our upcoming webinar

    Genomic profile availability impact on NSCLC patient outcomes in real world study and daily practice
    UPDATE: Thursday, Aug. 22, 2024, 1:00–2:00 PM ET

    Webinar presenters Melina Marmarelis, MD, MSCE, and Salvatore Fortunato Priore, MD, PhD, will discuss a real-world study cohort utilizing electronic health records to assess the impact of the availability of genomic profiles on guiding first-line therapy and patient outcomes. They found that the availability of molecular genotyping results before first-line therapy was associated with significantly better overall survival, and that concurrent tissue and plasma testing was associated with higher odds of availability of results before first-line therapy.

    Read More »

  • Register for our Upcoming Webinar

    Tuesday, August 13, 2024, 1:00 PM–2:00 PM ET

    Webinar presenter Jerald Radich, MD, Professor, University of Washington School of Medicine, Member Clinical Research Division, Kurt Enslein Endowed Chair, Fred Hutchinson Cancer Research Center will discuss the new NCI program in precision medicine (“myeloMATCH”), especially the groundbreaking rapid genetic testing using the NCI Myeloid NGS Assay. This webinar will help you identify the implications of rapid (<72 hour) cytogenetic, flow cytometry, and NGS mutation testing on enabling expeditious patient assignment to particular myeloMATCH clinical trials based on matching their risk group and genetic lesions to available target therapies.

Image Credits: [do_widget id=enhancedtextwidget-12].

AMP Case Reports



JULY 2024

  • Labs juggle string of LDT unknowns

    July 2024—Like a long-awaited second act, the FDA’s final rule regulating laboratory-developed tests as medical devices took the stage this spring. As with any FDA performance, this one opened to mixed reviews. The spring curtain-raising followed the earlier proposed rule from last October, which drew some 6,500 responses during the public comment period. If that was an out-of-town tryout, no one quite knew what to expect from the rewrite, or if there would even be one. As it turns out, there were indeed changes, but they didn’t necessarily bring clarity. As Jane Pine Wood, counsel for McDonald Hopkins, puts it, the final rule “certainly raised a whole lot more questions than it answered.” The rule calls for a four-year, five-stage phaseout policy with the FDA enacting greater oversight of in vitro diagnostic products that are offered as LDTs. Stage one, beginning on May 6, 2025, calls for labs to comply with medical device reporting requirements, correction and removal reporting requirements, and quality system requirements regarding complaint files.

    Read More »

  • HPV test self-collection set in motion

    July 2024—With the Food and Drug Administration approval in May of two HPV self-collection devices for use in clinic settings, physicians in and out of the laboratory are optimistic the approach can reach underscreened patients, even if FDA approval is only a first step.

  • Mayo pathologists create and test their own AI algorithms

    July 2024—A Mayo Clinic project is “democratizing artificial intelligence,” its leaders say, by enabling pathologists with varying levels of AI expertise—most of whom had never before participated in an AI project—to create and implement algorithms.

  • Using LEAP, Saudi laboratory attains accreditation

    July 2024—Earlier this year the laboratory at King Salman Armed Forces Hospital joined more than 120 other Saudi labs in achieving CAP accreditation. And it did so with a boost from LEAP. The 665-bed hospital needed to adopt standards for nearly all technical specialties and comply with more than 1,000 CAP requirements.

Image Credits: [do_widget id=enhancedtextwidget-12].

In Every Issue

  • From the President’s Desk

    July 2024—Remote sign-out has become a major issue for pathologists, spurred in large part by the COVID-19 pandemic and the CAP’s advocacy efforts that led to our ability to sign out cases from other locations. The Centers for Medicare and Medicaid Services has allowed remote sign-out to continue long after the public health emergency was declared over and is considering making this a permanent rule. I recognize how popular remote sign-out has become and have enjoyed many of its advantages in my own practice. However, I also see a few possible unintended consequences that I think are very important for us to consider before we let things get too far.

    Read More »

  • Clinical pathology selected abstracts

    July 2024—People with sickle cell disease may undergo treatment with the medication voxelotor, which can increase hemoglobin levels and help reduce hemolysis. A clinician treating a sickle cell disease patient with voxelotor may want to know the whole blood concentration of the drug to better monitor the patient’s treatment response, inform therapy, or confirm the patient is complying with the directions for use of the drug. Voxelotor binds to the alpha subunit of hemoglobin and results in the hemoglobin molecule being more likely to stay in the oxygenated conformation. In vivo concentrations of voxelotor cannot be measured in most clinical settings. However, voxelotor has been found to cause peak splitting in common forms of hemoglobin measurement, such as capillary zone electrophoresis (CZE) and high-performance liquid chromatography (HPLC)—that is, the classic peaks for each hemoglobin species split into a peak that has bound drug and a peak that does not.

  • Anatomic pathology selected abstracts

    July 2024—The 2022 International Society of Urological Pathology consensus conference on urinary bladder cancer working group two was tasked with providing evidence-based proposals on applying grading to noninvasive urothelial carcinoma with mixed grades; invasive urothelial carcinoma, including subtypes and divergent differentiations; and pure non-urothelial carcinomas. Studies suggested that predominantly low-grade noninvasive papillary urothelial carcinoma with focal high-grade component has an intermediate outcome between low- and high-grade tumors. However, no consensus was reached on how to define a focal high-grade component.

  • Molecular pathology selected abstracts

    July 2024—Telomeres are repetitive DNA sequences at the end of a chromosome that protect the chromosome from damage. They are maintained in equilibrium, as continual shortening at each round of DNA replication is counterbalanced by the de novo addition of telomere sequence repeats by telomerase. Failure to maintain the length distribution leads to short telomere syndromes that manifest as age-related degenerative diseases, such as pulmonary fibrosis, immunodeficiency, and bone marrow failure. In contrast, long telomeres can predispose people to cancer. Mutations that increase telomerase expression are one of the most common cancer-associated molecular findings.

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