The coverage decision limits the test to patients with advanced lung cancers who haven't been genomically profiled and who can't receive tissue-based testing.
The lab-developed test will use Thermo Fisher Scientific's Ion sequencing platform and will be applicable to most childhood cancers.
CSO Phil Stephens said the firm is finding specific genomic alterations that appear to affect sensitivity to immunotherapies, as it also advances overall mutation burden testing.
The company believes Indian clinicians and patients will be receptive to this new technology, but only in an efficient and actionable form.
The company plans to use the proceeds to support research collaborations and to expand its commercial team.
Clinical MDx firm OmniSeq has been an early-access user of the research-use-only assay and is working on validating it to predict checkpoint inhibitor response.
The company added three genes to its panel and said it has improved its detection limits, although validation data for these new performance numbers is not yet published.
A Counsyl study suggests that just half of individuals go through with insurance-mandated pretest genetic counseling, paying out of pocket or canceling the test instead.
While undergoing parallel review for its FoundationOne test by the FDA and CMS, the firm will continue to work with its local MACs on reimbursement.
The company also said that its FoundationOne test has been accepted for parallel review as part of the Expedited Access Pathway program with the FDA and CMS.