Summary of the year 2021


There is no doubt that in 2021 precision oncology made huge steps forward on the promise of targeted treatment, both on biomarkers as well on new therapies, especially in lung and breast cancer, with CRC as an emerging indication.

Indeed, one of the most remarkable breakthrough of the year are KRAS G12C inhibitors for NSCLC, along with different strategies to select patients by both tissue or liquid biopsy. NSCLC also had an important unmet need being addressed, with treatment targeting patients with EGFR exon 20 insertion mutations. Liquid biopsy is an important element on the expansion of new treatments, yet, it is important to keep in mind the current lab capability to ensure that patients are properly identified restrictively of setting.

Tissue-agnostic therapy saw important results, with Her2 being added to the list of alternatives together with NRTK and FGFR. The result from clinical trials shows that there will be a positive impact especially for breast cancer patients. Moreover, immunooncology saw an expansion to a broad range of indications, including NSCLC, TNBC, CRC and esophageal cancer. Despite all advances, the use of multiple assays does pose a major challenge for the adoption of testing in the different settings, which can lead to a large gap on the patient identification.

To tackle this issue, further harmonization studies were presented at ESMO this year for PD-L1, yet for some indications, concordance were suboptimal, which represent a major challenge for routine testing.

Furthermore, the upcoming IVDR implementation in the EU has risen even higher concerns on laboratory protocols and resources. To cope with the challenges also introduced by COVID, the European Commision decided on an additional 1- to 3-year transition phase (depending on the product class), giving more time for laboratories to meet the new regulatory requirements.

2021 is also an important milestone for patient access to broader diagnostics in many countries worldwide. In Japan, CGP tests for solid tumors were included into the NHI. In Germany and Sweden, reimbursement was granted for specific genetic signatures for breast cancer patients, while in Italy, a special funding was created with similar aim. In Spain, molecular diagnostics started to be covered in the region of Catalonia, while broader genetic tests were approved by the government to be incorporated in the national public system. In France, BCR-ABL was included into the formal reimbursement price list. In addition, commercial tests for MRD determination started to be locally financed by a private contractor in the US.

Moreover, public-private partnerships in countries with restricted testing capabilities such as in Argentina or in Saudi Arabia have been essential to enable equal access to biomarker testing.

Yet, more efforts must be taken to improve testing access for all patients, especially now that the landscape is moving towards an earlier and broader biomarker testing both through the use of large NGS panels in tissue and liquid biopsies, and through the incorporation of genetic signatures to guide treatments.

As you can see, there is still a long way to go, and from IPBA we are working on how to better address these issues enabling patients with access to high quality biomarker testing. Contact us to further understand how IPBA can help on your market access and diagnostic implementation strategy.


Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors