News Highlights – November 2021


In this late fall the development of advanced diagnostics tests is fueled by new companies' partnerships, regulatory approvals and public funding worldwide.

In the liquid biopsy space, Burning Rock and Merck KGaA entered a CDx agreement for the MET inhibitor tepotinib in the Chinese market with the OncoCompass Target. AstraZeneca started a strategic collaboration with Saga Diagnostics to develop digital PCR assays for methylated targets in both liquid and tissue biopsies. In the UK, Guardant Health and The Royal Marsden NHS Foundation Trust have partnered to offer inhouse liquid biopsy testing. Bluestar Genomics presented data on their liquid biopsy test enabling early identification of patients with new-onset diabetes with 51.5% sensitivity and 98% specificity. Additionally, Datar Cancer Genetics received FDA breakthrough designation for its TriNetra blood test, which has demonstrated accuracy >99% for detecting early-stage breast cancer patients.

Further on the diagnostics field, Veracyte presented further clinical evidence on the use of Afirma Genomic Sequencing Classifier for reducing unnecessary surgeries in patients with indeterminate thyroid nodules. In Europe, Genetron received the CE-mark for their Health’s Onco PanScan panel and Roche launched the new cobas 5800.

On reimbursement, in the USA, Palmetto released a local coverage decision of commercial tests for MRD determination under specific criteria. Veracyte kept its momentum with the Prosigna Breast Cancer Test now reimbursed in Sweden, following a similar decision by the G-BA in Germany.

This month’s drug approvals include FDA granting Merck’s KEYTRUDA (pembrolizumab) as adjuvant therapy for patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy. In parallel, European Commission approved Roche’s Gavreto (pralsetinib) for the treatment of advanced NSCLC patients harbouring RET fusions, as well as Gilead’s Trodelvy (sacituzumab govitecan) as a 2L for treatment of metastatic TNBC. EU CHMP also recommended conditional approval for Amgen's Lumykras (sotorasib) for previously treated, advanced NSCLC patients harboring KRAS G12C mutations.

Summary of news (with links)


Regulatory decisions on Rx (11)


Dx approvals, market access and reimbursement (5)



Latest diagnostic developments, investment and CDx deals (9)



Clinical trials and drug development (16)



Observational studies (5)


Merge and acquisitions (3)


Partnerships (16)



Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors