The rate of global molecular testing is low and is limited by a number of factors, including cost, quality, turn-around time, access, and lack of awareness of testing.
Matthew Smeltzer, PhD, of the University of Memphis
Matthew Smeltzer, PhD
The rate of global molecular testing is low and is limited by a number of factors, including cost, quality, turn-around time, access, and lack of awareness of testing, according to survey results published in the Journal of Thoracic Oncology.1
Of 2537 survey responses, which consist of more than 4 practice specialties spanning 102 countries, more than 6 of 10 respondents (61%) indicated that molecular testing rates are less than 50% in their country, with the lowest rates reported in Latin America and the rest of the world (P <.0001).
Additionally, approximately 4 of 10 respondents (39%) were not satisfied with the state of molecular testing in their country due to the turn-around time and uncertainty regarding the reliability and readability of the results.
“The risk of death for patients with non—small cell lung cancer is substantially reduced when a gene alteration is identified and the available targeted therapy is administered” lead study author and International Association for the Study of Lung Cancer (IASLC) committee member, Matthew Smeltzer, PhD, of the University of Memphis, said in a press release.2 “Molecular testing of lung cancer is important to ensure that patients receive optimal treatment; however, the current state of molecular testing is not well understood. To address this gap, the IASLC survey on molecular testing evaluated perspectives on the current state of molecular testing across the world,” Smeltzer and co-investigators wrote.
The survey was distributed to members of the IASLC and other global health care professionals who are involved in the treatment of patients with lung cancer, including physicians, nurses, advanced practice providers, and pharmacists.
The online survey consisted of a 7-question introduction, followed by 32 questions for medical oncologists requesting tests and treating patients, 45 questions for pathologists on performing/interpreting assays, and 24 questions for surgeons, pulmonologists, and radiologists on tissue acquisition. In the third portion of the survey, respondents were asked to provide written feedback on 3 to 5 barriers that limit the use of molecular testing in their country. Respondents were provided with the option of submitting personalized or anonymous responses.
Respondents’ countries were grouped into 5 geographic regions, including Asia, Europe, Latin America, the United States/Canada, and parts of the Middle East, Africa, and the Pacific Islands (rest of the world).
Fifty-two percent of responses came from Asia, followed by 19% from Europe, 11% from Latin America, 11% from the United States/Canada, and 7% from the rest of the world. Respondents were predominantly medical oncologists (45%), followed by pulmonologists (12%), thoracic surgeons (12%), pathologists (9%), and non-clinical scientists or other (22%).
The majority of participants responded to the requesting tests/treating patients track (66%), followed by the tissue acquisition track (13%), and performing/interpreting assays track (12%).
In the tissue acquisition track, 67% of respondents believed that less than half of the patients in their country receive molecular testing, with comparable regional variation (P = .0017), versus 59% who believed that more than half of patients in their institution receive molecular testing.
In terms of the most commonly tested alterations according to respondents in the testing/treating patients track, EGFR (99%) was the most common, followed by ALK (95%), ROS1 (79%), and other (less than 50%). EGFR, ALK, and ROS1 were the top 3 tested alterations across all regions, but all were less frequently sent for in the rest of the world (P = .0002, P = .0264, P <.0001, respectively).
Respondents in the performing/interpreting assays track indicated that EGFR (94%), ALK (83%), KRAS (69%), BRAF (68%), ROS1 (64%), HER2 (56%), and other (less than 50%) alterations were sent for within their own laboratory. In this track, EGFR, ALK, and KRAS were listed as the top tested alterations across all regions, with no regional differences.
Additionally, among respondents in this track, 57% use multiplex assays with a lower frequency in Asia and Latin America (P = .0204), suggesting that some multiplex assays are not inclusive of MET, RET, or other alterations.
Furthermore, 87% of respondents said that they use liquid biopsies in certain cases, the lowest proportion of which was reported in Latin America and the rest of the world (P <.0001). According to respondents in this track, 69% of laboratories offer liquid biopsies, with the lowest frequencies in the United States/Canada and the rest of the world (P = .0013). However, only 37% of these laboratories reported that at least 10% of molecular tests are performed with liquid biopsies.
The most common barriers to molecular testing respondents listed included the cost, quality, access, awareness, and timing of the assay. In terms of cost, investigators found discordance among the payers for molecular testing in the requesting tests/treating patients track, ranging from the patient (63%) to public/governmental support (40%) to pharmaceutical companies (29%) to private health insurance (16%). Respondents in the performing/interpreting assays track listed public/government support (61%) as the primary means of payer support, followed by the patient (44%), pharmaceutical companies (29%), and private health insurance (27%).
Regarding quality, the most common reasons for failed molecular testing included an insufficient amount of tumor cells (83%), inadequate tissue quality (55%), inadequate assay sensitivity/assay use failure (18%), and inadequate technical expertise in the laboratory (10%). The majority of respondents in the requesting tests/treating patients track (82%) felt that the laboratories they use likely or definitely perform validated molecular tests for lung cancer, and 74% felt that the laboratories are likely or definitely part of outsourced quality control programs for molecular testing. The most common reasons for not performing the validation tests, included lack of financial support (71%), inadequate technical expertise (57%), and lack of time (14%). Moreover, 47% of respondents reported that there is no protocol in place to improve the quality of the tissue samples in their country.
In terms of access, 30% of respondents in the requesting tests/treating patients track have access to molecular testing laboratories within their own institutions, 43% completely outsource molecular testing, and 28% test in-house and outsource molecular testing.
Regarding awareness, 67% of respondents in the requesting tests/treating patients track were aware of the most recent College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology guidelines for molecular testing. Although 75% stated that they hold multidisciplinary tumor boards, only 55% reported that the multidisciplinary tumor boards meet at least monthly.
The final barrier respondents listed to molecular testing was the time it takes to order and receive molecular testing results. Twenty-nine percent of respondents in the requesting tests/treating patients track reported that it takes approximately 10 days or more to receive results from molecular testing, with the highest percentage in North America (P <.0001). The average turn-around time respondents listed in the performing/interpreting assays track for providing the results to the physician/patient was listed as follows: 0 to 5 days (29%), 6 to 10 days (53%), 11 to 15 days (16%), and more than 15 days (2%), with no significant difference between regions (P = .3154).
“Many of the barriers identified can be addressed with improved awareness and standardization of processes. The landscape of molecular testing is complex and rapidly evolving, highlighting the need for regular updates to expert statements and guidelines.
Continuous education around molecular testing in lung cancer should be intensified on national and international levels to ensure patients receive optimal therapy,” Smeltzer and co-investigators concluded.