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Development and Approval of New Targeted Therapies is Driving the Demand for Next-generation Sequencing Services

   August 31, 2021

Next-generation sequencing (NGS) technology advancements are changing the way doctors diagnose and treat cancer. Traditional cancer therapies generally involve treatment approaches that are non-partial towards cancer cells and can result in many serious side effects. New targeted cancer treatments that use genomic data to provide patient-specific treatment are precision oncology. Precision oncology is a rapidly developing field that has already entered mainstream clinical practice. It involves the molecular profiling of cancer cells to identify the targetable alterations, also known as biomarkers. The quick and reliable sequencing of multiple genes at once is possible with NGS technology.

Technology is becoming more widespread in the treatment of cancer. It can be attributed to the speed, accuracy, and increasing affordability of NGS. NGS has helped develop precision medicine, which tailors treatment based on a person's disease-causing molecular changes. While it has been used in various scenarios, oncologists currently use it to sequence their patients' biopsy samples to match them to medicines targeting genetic abnormalities that drive tumor growth. Some of the currently available targeted therapies with their corresponding biomarkers are mentioned below:

  • Cancer Type - Non-small cell lung cancer, Target Marker - EGFR, and Suggested Therapy - Erlotinib, Afatinib, Gefitinib, Osimertinib, Dacomitinib, Cetuximab, and Panitumumab
  • Cancer Type - Non-small cell lung cancer, anaplastic large cell lymphoma, histiocytosis, Target Marker - ALK, and Suggested Therapy -Alectinib, Crizotinib, Ceritinib, Brigatinib, and Lorlatinib
  • Cancer Type - Breast, ovarian, bladder, pancreatic, and stomach cancers, Target Marker -HER2, and Suggested Therapy -Trastuzumab, Pertuzumab, Neratinib, Lapatinib, Tucatinib, Ado-trastuzumab ematansine, and Fam-trastuzumab deruxtecan
  • Cancer Type - Ovarian and breast cancers, Target Marker -BRCA, and Suggested Therapy - Olaparib, Talazoparib

NGS is useful in detecting clinically actionable mutations in cancer patients in several studies. The Genomics Evidence Neoplasia Information Exchange (GENIE) estimates that 30% of tumors sequenced in the GENIE consortium have a mutation that a currently available targeted therapy could target.

The techniques such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) have been conventionally used for molecular profiling of cancer cells to identify the targetable alterations. However, for using these techniques, a purpose-made assay is required for each analyte, and every biomarker has to be pre-specified to be detected.  NGS can simultaneously analyze various genetic alterations, including mutations, copy number variations (CNV), translocations, and fusions in multiple genes. As a result, compared to serial single-biomarker analyses, it enables a more efficient, cost-effective, and tissue-saving tumor study, especially given the genomic complexity known to occur inside tumor cells.

Thus, owing to the decreasing costs and turnaround time of NGS, the improvement in bioinformatics analyses, and the harmonization of knowledgebases to facilitate the clinical interpretation of genomic results, NGS services are increasingly being used for genomic profiling for targeted cancer therapy applications.

Some of the recent developments in this field include:

  • In August 2021, AnPac Bio-Medical Science Co., Ltd. (China) and F. Hoffmann-La Roche AG (Switzerland) collaborated to combine their respective cancer screening, diagnostic, and treatment-guiding technologies to create a personalized product and service package for patients with the risk of cancer.
  • In August 2021, the U.S. FDA approved KORSUVA (difelikefalin), a KOR agonist, as a targeted therapy drug to treat moderate to severe pruritus associated with chronic kidney disease in adults undergoing treatment hemodialysis. The treatment was developed between Cara Therapeutics Inc. (U.S.) and Vifor Pharma Management Ltd. (Switzerland).
  • In July 2021, the U.S. FDA approved liquid biopsy next-generation sequencing test, FoundationOneLiquid CDx, from Foundation Medicine, Inc. (a subsidiary of F. Hoffmann-La Roche AG) for a companion diagnostic identify patients eligible for treatment with Capmatinib.

Thus, there is a rising demand for targeted precision therapies for cancer, with a rising prevalence of cancer worldwide. Therefore, the launch of new targeted therapies and investments in the development of targeted therapies is expected to drive the global next-generation sequencing services market at a CAGR of 20.4% to reach $14.1 billion by 2028, according to Meticulous Research®.

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