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FoundationOne ® CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients who may benefit from treatment in accordance with the approved therapeutic product labeling for 28 drug therapies. F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors. F1CDx reports known and likely pathogenic short variants (SVs), copy number alterations (CNAs), and select rearrangements, as well as complex biomarkers including tumor mutational burden (TMB) and microsatellite instability (MSI), in addition to genomic loss of heterozygosity (gLOH) in ovarian cancer. CGP services can reduce the complexity of biomarker testing, enabling precision medicine to improve treatment decision-making and outcomes for cancer patients, but only if test results are reliable, accurate, and validated clinically and analytically to the highest standard available. The analyses presented herein demonstrate the extensive analytical and clinical validation supporting the F1CDx initial and subsequent FDA approvals to ensure high sensitivity, specificity, and reliability of the data reported. The analytical validation included several in-depth evaluations of F1CDx assay performance including limit of detection (LoD), limit of blank (LoB), precision, and orthogonal concordance for SVs (including base substitutions [SUBs] and insertions/deletions [INDELs]), CNAs (including amplifications and homozygous deletions), genomic rearrangements, and select complex biomarkers. The assay validation of >30,000 test results comprises a considerable and increasing body of evidence that supports the clinical utility of F1CDx to match patients with solid tumors to targeted therapies or immunotherapies based on their tumor’s genomic alterations and biomarkers. F1CDx meets the clinical needs of providers and patients to receive guideline-based biomarker testing, helping them keep pace with a rapidly evolving field of medicine.

FoundationOne.sup.® CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients who may benefit from treatment in accordance with the approved therapeutic product labeling for 28 drug therapies. F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors. F1CDx reports known and likely pathogenic short variants (SVs), copy number alterations (CNAs), and select rearrangements, as well as complex biomarkers including tumor mutational burden (TMB) and microsatellite instability (MSI), in addition to genomic loss of heterozygosity (gLOH) in ovarian cancer. CGP services can reduce the complexity of biomarker testing, enabling precision medicine to improve treatment decision-making and outcomes for cancer patients, but only if test results are reliable, accurate, and validated clinically and analytically to the highest standard available. The analyses presented herein demonstrate the extensive analytical and clinical validation supporting the F1CDx initial and subsequent FDA approvals to ensure high sensitivity, specificity, and reliability of the data reported. The analytical validation included several in-depth evaluations of F1CDx assay performance including limit of detection (LoD), limit of blank (LoB), precision, and orthogonal concordance for SVs (including base substitutions [SUBs] and insertions/deletions [INDELs]), CNAs (including amplifications and homozygous deletions), genomic rearrangements, and select complex biomarkers. The assay validation of >30,000 test results comprises a considerable and increasing body of evidence that supports the clinical utility of F1CDx to match patients with solid tumors to targeted therapies or immunotherapies based on their tumor's genomic alterations and biomarkers. F1CDx meets the clinical needs of providers and patients to receive guideline-based biomarker testing, helping them keep pace with a rapidly evolving field of medicine.

FoundationOne®CDx (F1CDx) is a United States (US) Food and Drug Administration (FDA)-approved companion diagnostic test to identify patients who may benefit from treatment in accordance with the approved therapeutic product labeling for 28 drug therapies. F1CDx utilizes next-generation sequencing (NGS)-based comprehensive genomic profiling (CGP) technology to examine 324 cancer genes in solid tumors. F1CDx reports known and likely pathogenic short variants (SVs), copy number alterations (CNAs), and select rearrangements, as well as complex biomarkers including tumor mutational burden (TMB) and microsatellite instability (MSI), in addition to genomic loss of heterozygosity (gLOH) in ovarian cancer. CGP services can reduce the complexity of biomarker testing, enabling precision medicine to improve treatment decision-making and outcomes for cancer patients, but only if test results are reliable, accurate, and validated clinically and analytically to the highest standard available. The analyses presented herein demonstrate the extensive analytical and clinical validation supporting the F1CDx initial and subsequent FDA approvals to ensure high sensitivity, specificity, and reliability of the data reported. The analytical validation included several in-depth evaluations of F1CDx assay performance including limit of detection (LoD), limit of blank (LoB), precision, and orthogonal concordance for SVs (including base substitutions [SUBs] and insertions/deletions [INDELs]), CNAs (including amplifications and homozygous deletions), genomic rearrangements, and select complex biomarkers. The assay validation of >30,000 test results comprises a considerable and increasing body of evidence that supports the clinical utility of F1CDx to match patients with solid tumors to targeted therapies or immunotherapies based on their tumor’s genomic alterations and biomarkers. F1CDx meets the clinical needs of providers and patients to receive guideline-based biomarker testing, helping them keep pace with a rapidly evolving field of medicine.

A poem is presented.

A poem is presented.

Poems in this manuscript were borne out of a curiosity about—and further research into—pirates and piracy. The title, PLAN/K, is a nod to the primarily fictionalized practice of walking the plank and a play on Plan B. Plan B, of course, signifies alternative plans in general, but it is also the name for the emergency contraceptive pill. If Plan B manages accidents, then Plan K cultivates accidents through writing strategies that privilege mishearing and misreading. Furthering the spirit of piracy, and pilfering particularly, the poems incorporate anagrams and puns, figures of speech often considered base or crude, but which can also be considered as devices that disrupt and reroute language while allowing the uncanny in language to surface. The essay explores footnotes and endnotes as forms in three contemporary books of poetry written by women. Martenson’s Xq28 and Boully’s first book, The Body, radically foreground the footnote by making it the sole textual component on the page. Through her use of footnotes, the essay argues that Martenson highlights an erased body in order to critique lesbian erasure and uses the margins to frame a subversive anti-hegemonic speaking position. In contrast, the essay argues Boully invests in psychological reactions to a missing body by staging repression and the return of the repressed through alternately subsuming and subsiding footnotes and the covering over (more or less successfully) of the missing body of a dead lover who is figured in the blank textual body. Whereas The Body and its form are motivated by the tenets of melancholia, in her second book, [one love affair]*, the essay argues Boully stages processes of mourning. Following Jeffrey Adams, the essay considers intertextuality in terms of “aesthetic object-relating.” The essay argues that palimpsest and endnotes perform a reactivation of object-relating and help the speaker of the poems reinvest in relationships with other subjects rather than withdraw from such investments because of an inability to grieve the lost object.

KOJI Mori arrived at our school in July, from Ishikawa prefecture (State) on the island of Honshu in Japan.

THIS year many budding artists are attending Northlakes High.

Background and AimsPregnant people with obesity class 3 are thought to be at higher risk of adverse respiratory-events. There is little information in the literature on the incidence and severity of obesity-related postpartum respiratory depression. Our institution’s current standard of practice is to consider maintaining patients with BMI>50 who have received long-acting neuraxial opioids following cesarean delivery(CD) in the Labour and Delivery Unit for respiratory monitoring. This represents a significant workload for the system. This study aimed to determine the incidence of respiratory complications in this subset of patients.MethodsWe reviewed medical records of patients with BMI>40 who underwent CD and received long-acting neuraxial opioids between January 2015- December 2022. Patients were divided into three groups according to their BMI: 40-49, 50-59, and >60. Clinically significant respiratory-events (see the definition in table 1) within the first 24 hours post-CD were compared.ResultsDemographics, patient characteristics, comorbidities, and respiratory events are presented in table 1. No severe respiratory events were observed in any of the groups from 497 patients (figure 1). Three moderate respiratory-events were observed, one in each group. Thirteen, 9 and 5 mild respiratory-events were observed in BMI 40-49, 50-59, and >60groups, respectively.Abstract EP197 Table 1Patient characteristics and incidence of postoperative respiratory eventsAbstract EP197 Figure 1Comparison of the respiratory events (%) per study groups[Figure omitted. See PDF]ConclusionsOur results suggest that there is no association between BMI and severe respiratory-events after CD under neuraxial anesthesia and the use of long- acting neuraxial opioids. Extended admission to a high-acuity setting may not be necessary for the majority of these patients. In addition to BMI, the presence of patient comorbidities and physician assessment may prove valuable in determining the necessity for admission.Initial Ethics Commity Approval Letter 22-0202-C