News Highlights – December 2021


The closing of 2021 brought outstanding news on the accessibility of predictive diagnostics in Europe with key government decisions taken by two Member States.

In Spain, National Healthcare will incorporate predictive genetic analysis with public funding in the healthcare portfolio of common specialized care services, while Italy will establish regional Molecular Tumor Boards (MTBs) allowing the access to targeted therapies and the determination of extended genomic profiling tests in reference centers.

Regarding CDx approvals, this month included FoundationOneCDx, receiving FDA approval as a CDx for the following therapies: Pfizer’s BRAF inhibitor monotherapies Braftovi (encorafenib)/Mektovi (binimetinib) targeting BRAFV600E; and Novartis’ BRAF/MEK inhibitor Tafinlar (dabrafenib) plus Mekinist (trametinib) combo targeting BRAFV600E or V600K mutations. Thermo Fisher Scientific's Oncomine Dx Target Test was also approved by FDA as a CDx for NSCLC patients with EGFR exon20-insertion mutations for potential treatment with Janssen’s Rybrevant (amivantamab-vmjw).

Paralelly, Singular Genomics launched its G4 platform, a NGS sequencing platform for a wide range of applications including research in oncology and immunology. Mainz Biomed partnered with Ganzimmun Diagnostics to commercialize its colorectal cancer detection test ColoAlert, and Biodesix partnered with Spesana to automate the use of molecular diagnostics in clinical workflows for lung cancer, by integrating electronic ordering of Biodesix tests.

As for the liquid biopsy field, QIAGEN and Denovo Biopharma partnered to develop a blood-based CDx test to identify patients likely to respond to Denovo’s DB102TM, a new investigational cancer treatment for Diffuse Large B-Cell Lymphoma (DLBCL), whereas Freenome partnered with Siemens Healthineers for the identification of blood-based biomarkers for early diagnosis of breast cancer. In addition, Labcorp agreed to acquire Personal Genome Diagnostics (PGDx) to complement its liquid biopsy capabilities and to further expand its portfolio of NGS-based genomic profiling in oncology.

Among drugs’ regulatory decisions, Merck’s Keytruda (pembrolizumab) was approved by the FDA as adjuvant treatment for adult and pediatric (≥12 years of age) patients with stage IIB or IIC melanoma following complete resection; and was approved by the Japanese MHLW in combination with Lenvima (lenvatinib) for patients with unresectable, advanced or recurrent endometrial carcinoma that progressed after cancer chemotherapy. Janssen received EMA’s conditional marketing authorisation for Rybrevant (amivantamab) for patients with advanced NSCLC with EGFR exon 20 insertion mutations after failure of platinum-based therapy. In China, CStone Pharmaceuticals received approval from NMPA for Cejemly (sugemalimab) for advanced NSCLC as 1L treatment plus chemo.

In addition, Daiichi Sankyo’s patritumab deruxtecan was granted U.S. FDA Breakthrough Therapy Designation for the treatment of patients with metastatic or locally advanced EGFR-mutated (NSCLC) with disease progression or after 3rd-gen TKI and platinum-based therapies, while Merck’s Tepmetko (tepotinib) as monotherapy received EMA’s CHMP positive opinion for patients with advanced NSCLC with METex14 skipping alterations.

Summary of news (with links)


Regulatory decisions on Rx (12)



Dx approvals, market access and reimbursement (5)



Latest diagnostic developments, investment and CDx lead  (10)



Clinical trials and drug development (21)



Observational studies (6)



Merge and acquisitions (2)



Partnerships (15)



Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors