Israel Ministry of Health Expands Testing Coverage for Non-Small Cell Lung Cancer Patients
Local laboratories approved to develop and utilize comprehensive molecular profiling assays using Thermo Fisher Scientific?s Oncomine Comprehensive Assay Plus
Carlsbad, Calif. -- Starting this month, comprehensive molecular profiling is now covered for patients with non-small cell lung cancer (NSCLC) in Israel, as outlined in a letter from the Israeli Ministry of Health to medical directors of the country’s health insurance funds. According to the letter, every NSCLC patient in the country is eligible for comprehensive molecular profiling as part of the expansion of the Health Services Basket.
Under the decision, local pathology laboratories that have received approval from the Ministry of Health Laboratories Division will be able to perform comprehensive molecular profiling for NSCLC patients in medical centers throughout the country. Unlike time-consuming, single-gene testing approaches, comprehensive molecular profiling leverages next-generation sequencing (NGS) to simultaneously profile hundreds of genes for key biomarkers associated with targeted cancer therapies.
“The Ministry of Health’s decision is an important milestone for cancer testing and a win for cancer patients in Israel,” said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “The expanded coverage helps promote broader adoption and standardization of in-house NGS testing. It also enables physicians to more quickly identify patients who may benefit from targeted therapies, ultimately improving outcomes for cancer patients across the country.”
The Ministry of Health calls for comprehensive molecular profiling for NSCLC patients in accordance with National Comprehensive Cancer Network (NCCN) Guidelines. The Hadassah Medical Center, Rambam Health Care Campus, Sheba Medical Center, Soroka Medical Center and Maccabi Healthcare Services have already received approval to perform testing using the assays they have validated based on Oncomine Comprehensive Assay Plus, a pan-cancer test that enables comprehensive genomic profiling of more than 500 genes.
In cases where comprehensive molecular profiling cannot be performed, such as when tumor sample is insufficient, oncologists and pathologists may pivot to broad molecular profiling, coverage for which the Ministry of Health approved in April for tests that assess up to 100 genes. Six laboratories are already approved to perform broad molecular profiling using the Oncomine Dx Target Test, an NGS-based test that evaluates patient tumor samples for up to 23 biomarkers associated with NSCLC.
Oncomine Dx Target Test previously received premarket approval from the U.S. Food and Drug Administration in 2017 and it is currently reimbursed by government and commercial insurers in the U.S., Europe, Japan and South Korea, covering more than 550 million lives globally. Rhenium Oncotest distributes both NGS tests in Israel on behalf of Thermo Fisher.
“We are pleased with the decision to provide reimbursement for NGS-based molecular testing in Israel,” said Lior Soussan-Gutman, Ph.D., CEO of Rhenium Oncotest. “We are prepared to support laboratories throughout the country and to carry out the tests according to the Health Services Basket decision.'
The Ministry of Health is expected to provide updates on additional laboratories approved to perform tests in the coming weeks.
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