CTI BioPharma Corp.

No abstract

Objectives To verify a single platform of hemostasis instrumentation, the ACL TOP 50 Family, comprising 350, 550, and 750 instruments, across a large network of 60 laboratories. Methods Comparative evaluations of instrument classes (350 vs 550 and 750) were performed using a large battery of test samples for routine coagulation tests, comprising prothrombin time/international normalized ratio, activated partial thromboplastin time (APTT), thrombin time, fibrinogen and D-dimer, and using HemosIL reagents. Comparisons were also made against existing equipment (Diagnostica Stago Satellite, Compact, and STA-R Evolution) and existing reagents to satisfy national accreditation standards. Verification of manufacturer normal reference ranges (NRRs) and generation of an APTT heparin therapeutic range were undertaken. Results The three instrument types were verified as a single instrument class, which will permit standardization of methods and NRRs across all instruments (n = 75) to be deployed in 60 laboratories. In particular, ACL TOP 350 test result data were similar to ACL TOP 550 and 750 and showed no to limited bias. All manufacturer NRRs were verified with occasional minor variance. Conclusions This ACL TOP 50 Family (350, 550, and 750) verification will enable harmonization of routine coagulation across all laboratories in the largest public pathology network in Australia.

Introduction Digital microscopy systems are beginning to replace traditional light microscopes for morphologic analysis of blood films, but these are geographically restricted to individual computers and technically limited by manufacturer's constraints. We explored the use of a scanner‐agnostic web‐based artificial intelligence (AI) system to assess the accuracy of white blood cell (WBC) differentials and blast identification in haematological malignancies. Methods Digitized images of 20 normal and 124 abnormal peripheral blood films were uploaded to the web‐based platform (Techcyte©) and WBC differentials performed using the online AI software. Digital images were viewed for accuracy and manual cell reassignment was performed where necessary. Results were correlated to the ‘gold standard’ of manual microscopy for each WBC class, and sensitivity and specificity of blast identification were calculated. Results The AI digital differential was very strongly correlated to microscopy (r > .8) for most normal cell types and did not require any manual reassignment. The AI digital differential was less reliable for abnormal blood films (r = .50‐.87), but could be greatly improved by manual assessment of digital images for most cell types (r > .95) with the exception of immature granulocytes (r = .62). For blast identification, initial AI digital differentials showed 96% sensitivity and 25% specificity, which was improved to 99% and 84%, respectively, after manual digital review. Conclusions The Techcyte platform allowed remote viewing and manual analysis of digitized slides that was comparable to microscopy. The AI software produced adequate WBC differentials for normal films and had high sensitivity for blast identification in malignant films.

Background Acquired haemophilia A (AHA) is a rare acquired bleeding disorder that can present with life‐threatening bleeding. Aims To describe recent Australian use of recombinant porcine factor VIII (rpFVIII) replacement therapy as a haemostatic agent in patients with acquired haemophilia. Methods Four patients with acquired haemophilia treated in three different institutions around Australia in the past 12 months were included in the study. Haemostatic efficacy of Obizur (Takeda) was assigned by the treating haematologist according to previously published criteria. Results Six bleeds were treated with rpFVIII, three of which were initially refractory to treatment with recombinant VIIa. rpFVIII was rated efficacious in 100% of bleeds by 24 h. rpFVIII loading dose was 100 U/kg (100–120 U kg−1) and this increased the factor VIII level (via one‐stage FVIII assay) from <1–1.2% to 54–306% taken 0.5–1.5 h post‐infusion. Subsequent doses ranged from 40 to 60 U/kg twice daily or daily for 3 to 13 days. No rpFVIII related adverse events occurred. Three of the four patients achieved complete remission and were weaned from immunosuppression. One patient died prior to achieving partial remission, secondary to an arterial ischaemic event. Conclusion This case series demonstrates that recombinant porcine FVIII is efficacious to treat acute bleeds in acquired haemophilia, including in those who are refractory to bypassing agents. Doses of rpFVIII were able to be titrated based on FVIII level and clinical response.