Breast cancer is the most common malignancy among women in Rwanda. The pathology lab at Butaro Cancer Center in rural Rwanda processes over 450 breast samples yearly, of which about 200 are malignant breast cancers. Immunohistochemistry (IHC) for ER, PR and HER2 are breast biomarkers performed on all these malignant tumors to guide treatment and provide prognostic information. There are several challenges in testing for these breast biomarkers in a resource limited setting: maintaining the infrastructure and consumables required for IHC is a well-recognized challenge. IHC testing requires expensive reagents; there are no local suppliers for these reagents in the region, leading to supply chain problems, expiry of unused reagents if bought in bulk to limit costs, and frequent stock-outs when reagents cannot be procured efficiently. In addition, IHC requires highly skilled technicians to execute the detailed steps and maintain the highest quality control, and skilled pathologists to accurately interpret the results. There are newer technologies available now that may provide comparable diagnostic information as IHC, using systems that are potentially easier to deploy and at reduced cost. A breast cancer-specific assay cartridge was recently developed and validated for use on GeneXpert system already available in Butaro lab for Tuberculosis and chronic myeloid leukemia diagnostics. This assay, called Xpert Breast Cancer STRAT4 is a Conformité Européene in vitro diagnostic test (CE-IVD) assay that makes quantitative measurements of the expression levels of four mRNAs that encode key breast cancer protein biomarkers; ESR1 (ER), PGR (PR), ERBB2 (HER2/neu), and MKi67 (Ki-67 proliferation marker); using formalin-fixed paraffin embedded (FFPE) tissue specimens in less than 2 hours. We are currently conducting a comparative study of the STRAT4 assay and IHC at Butaro cancer center in Rwanda.

Background: Point-of-care (POC) technology can facilitate clinical management and improve outcomes for people living with HIV. We assessed integrating Human Papilloma Virus (HPV) POC testing for cervical cancer screening, in women starting antiretroviral therapy at a public health clinic in South Africa.
Methods: Women underwent routine cervical screening by liquid-based cytology (LBC). In parallel, Xpert® HPV POC testing was performed in the clinic laboratory using 4mls of the LBC sample to detect HPV16, HPV18/45 and 11 other high risk (hr) HPV types. The remaining LBC sample was sent to a central laboratory for cytology. HPV results were received within 24 hours and cytology results within 4-6 weeks. Women with abnormal cytology were referred for colposcopy to their nearest health facility.
Results: Of 76 women enrolled, 70 women, median age 31.0 (26.0-37.0) years, had HPV testing. Most women (49/70; 70%) tested positive for any hrHPV and 83.7% of these were >25-year-old. Mean CD4 count was lower among women testing HPV positive versus negative (378 vs 510 cells/µl, p=0.014). Cytology results were available for 63 women. Of these, 32 (50.8%) were normal, 1 (1.6%) ASCUS, 19 (30.2%) low-grade squamous intraepithelial lesion (LSIL), 6 (9.5%) high-grade SIL (HSIL) and 5 samples were inadequate for evaluation. High risk HPV was detected in 23/25 (92.0%) of women with either LSIL (18/19, 94.7%) or HSIL (5/6, 83.3%). None of the HSIL cases were HPV16 positive. Sixteen women with normal cytology, tested positive for HPV16 (3/16; 19%), HPV 18/45 (3/16; 19%) and other hrHPV (14/16; 88%) types. One woman with LSIL and one with HSIL tested negative for HPV.
Conclusion: Xpert® HPV POC testing was easy to implement in a clinic with on-site laboratory and helped to identify high-risk women. Its role should be further evaluated as a primary cervical screening tool or co-test with cytology.

Cervical cancer ranks 4th in incidence among females globally and the commonest cause of cancer death in Uganda. 6,959 new cases and 4,607 deaths occur every year. In 2020 WHO made a call towards cervical cancer elimination. Strategies include vaccinating 90% of girls by age 15, screening 70% of eligible women and treating 90% of those who require treatment.
In Uganda HPV vaccination uptake is still low at 88% for HPV1 and 41% HPV2. The screening uptake is equally low as 3.6 – 10% resulting into late presentation of the women. The current screening protocol targets women aged 25 – 49yrs, using VIA and treatment of pre-cancers with cryotherapy. This has suffered challenges. In the recently released WHO guidelines 2021, screening with HPV testing is the recommendation.
Our transition to HPV testing has had impact on the current protocol:
¥ Offers an opportunity to engage women, as it can be offered in a variety of settings, including at home, community centers, places of gathering, and clinical sites.
¥ Outreach workers or midlevel practitioners can perform screening, thus decreasing demands on scarce health human resources.
¥ Allows to focus scarce resources on follow-up of women who are HPV positive.
¥ Can be run on the current GXP machine meant for TB and HIV leveraging on the widely spread equipment and human resource.
¥ Led to lengthening of screening intervals.
¥ Experience with community-based self-collection has also confirmed substantial acceptability, with uptake rates of > 95% compared with attendance of 48.4% for screening by visual inspection with acetic acid (VIA) [14].
¥ Challenge is linkage to care : CHWs appear promising in rural settings.
¥ Need for effective health information systems.
In conclusion, HPV based testing seems to be the game changer in this scenario.