News Highlights – June 2021


The beginning of this summer saw an important landmark with the WHO report on AI application in healthcare, which includes the six key principles for AI design and use: autonomy, beneficence, transparency, responsibility and accountability, equity and sustainability. The report release is aligned with recent proliferation of AI platforms for big data management and data generation as well as for implementing diagnostic analysis. Just this June FDA granted Ibex with the Breakthrough Device Designation for its AI-based platform applied to IHC image analysis; and PathAI presented a quality control system for HER2 IHC analysis based on a machine learning algorithm during ASCO 2021. Moreover, Philips has been selected as the national partner in the Netherlands for creating the infrastructure for image data exchange.

June marked important developments beyond Europe and the US. In Japan, Eiken Chemical has started a partnership with Illumina to provide IVD kits for the MiSeq Dx platform, and AmoyDx received the MHLW approval for their Pan Lung Cancer PCR Panel. In Brazil, Dasa has performed further acquisitions consolidating its position in the Northeast and diversifying its product portfolio. Additionally, recent study on the use of OncotypeDx may lead to broader adoption by the SUS, a major win for Brazilian patients. Saudi Al Borg labs might also file for an IPO, fueling its leadership for biomarker testing in the gulf region. In South Korea, VUNO is expanding its services towards digital pathology, empowered also by a partnership with Samsung. In China, the partnerships Berry Oncology with Alibaba and Natera with BGI will lead to disruptive changes in the market and will have consequences in the international landscape.

On the MRD run, Guardant, Inivata and Natera have presented strong data during ASCO. Natera has taken the spotlight with the CIRCULATE-Japan data, the ADLT status for Signatera and the agreements with FMI and BGI.

I/O field saw multiple approvals, with Infigratinib for the treatment of cholangiocarcinoma (US), tislelizumab for NSCLC and hepatocellular carcinoma (China), pembrolizumab combined with chemotherapy for esophageal cancer or HER2-negative gastroesophageal junction adenocarcinoma and nivo+ipi for the treatment of Mismatch Repair Deficient or MSI-H metastatic colorectal cancer (EU).

Regarding targeted therapies, AstraZeneca and HUTCHMED’s savolitinib was granted conditional approval by NMPA for NSCLC patients with MET exon 14 skipping alterations. FDA also granted Mirati’s adagrasib with a breakthrough designation, following Amgen’s sotorasib last month.
Summary of news (with links)


Regulatory decisions on Rx (12)


Dx approvals, market access and reimbursement (7)


Latest diagnostic developments, investment and CDx deals (21)


Clinical trials and drug development (19)


Observational studies (5)


Merge and acquisitions (7)


Partnerships (32)



Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors