News Highlights – October 2021


October was pivotal month for biomarker testing landscape, especially for EU countries due to the updates on the implementation of the upcoming IVDR, extending the transition phase to cancer diagnosis IVD products, delaying 1 to 3 years depending on the product.

ESMO updated clinical practice guidelines for metastatic breast cancer. Patients with TNBC tumor should get PD-L1 testing and HR+/HER2- should have PIK3CA tested, both patient groups should get gBRCAm and PALB2 is optional. Further assessments for MSI, TMB and NTRK should be performed when alternative treatment is available and guided by ESCAT scores. On the clinical side, the updates on the SPIRIT guidelines add further recommendations on protocols and documentation for all molecular and cellular pathology as well as digital methods.

Regarding diagnostics, this month Agilent PD-L1 IHC 28-8 pharmDx was granted CE-IVD mark for gastric and esophageal cancer, and expanded PD-L1 IHC 22C3 pharmDx indications for TNBC. In the USA, Agilent’s Ki-67 IHC MIB-1 pharmDx was approved as the CDx for Verzenio (abemaciclib). This represents the first approval for Ki-67 with a score ≥20%. GeneCentric Therapeutics and Labcorp are collaborating to develop RNA-based gene signatures analysis, while, NanoString released a new panel to support research on ADC-based treatment.

As for liquid biopsy, the Ghanese Yemaachi will work with Lucence to study actionable mutations in ctDNA samples from women with breast cancer using the LiquidHALLMARK assay. Guardant initiated the ORACLE study to predict recurrence at an early onset for 11 types of tumors with Guardant Reveal Blood Test. Inivata is partnering with Princess Margaret Cancer Centre to evaluate the clinical benefit of InVisionFirst-Lung and RaDaR liquid biopsy assays in lung cancer.

One of the largest digital pathology initiatives has started, as Institut Curie is implementing broad AI-based analysis on all their breast cancer slide repository. Furthermore, the Proscia AI platform has shown high specificity (93%) and sensitivity (91%) in a multi-center retrospective study to automatically identify melanoma samples. Meanwhile, PathAI and Roche signed an agreement to offer digital pathology solutions through Roche's uPath software. In China, Xiangya Hospital will partner with KFBIO to expand digital pathology with a Remote Pathology Diagnosis Platform, allowing the use of centralized pathology equipment and software to hospitals in different provinces. Especially important in China, as the use of digital pathology is helping to bridge the limited number of pathologists.

As for this month’s drug approvals, FDA granted Enhertu (trastuzumab deruxtecan) Breakthrough Therapy Designation for patients with HER2+ metastatic breast cancer. It also granted Genentech’s Tecentriq (atezolizumab) as adjuvant treatment for Stage II-IIIA PD-L1≥1% NSCLC as well as Merck’s Keytruda (pembrolizumab) plus chemo for a subgroup of advanced cervical carcinoma. In Europe, BMS received EMA approval for Opdivo (nivolumab) plus chemo for HER2-, PD-L1+ (CPS ≥ 5) gastric and esophageal cancers, while Merck’s Keytruda (pembrolizumab) was approved for 1L of locally recurrent unresectable or metastatic TNBC expressing PD-L1 (CPS ≥10).

Summary of news (with links)


Regulatory decisions on Rx (17)

Dx regulation and approvals (3)

Latest diagnostic developments, investment and CDx deals (15)

Guidelines (2)

Clinical trials and drug development (10)

Observational studies (5)

Merge and acquisitions (2)

Partnerships (20)


Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors