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Life Tech Continues to Gather Evidence Backing NSCLC Dx Pervenio, As Commercialization Progresses


In marketing its newly launched Pervenio lung cancer prognostic test, Life Technologies' sales force is targeting specialist thoracic surgeons and medical oncologists in 48 US states.

After purchasing Pinpoint Genomics last year, Life Tech commercially launched Pervenio Lung RS, developed by Pinpoint, in September. The quantitative PCR-based assay gauges the expression of 14 genes and is intended for early-stage non-small cell lung cancer patients after they've had their tumors removed with surgery. The test analyzes formalin-fixed, paraffin-embedded tumor specimens and assesses the expression of genes associated with lung cancer progression, such as KRAS, BRAF, EGFR, HER2, ALK, and p53.

Life Tech performs testing with Pervenio through its CLIA lab in Sacramento, Calif.

The company has a national commercialization strategy for Pervenio, list priced at $3,995. In addition to marketing the test to thoracic surgeons and medical oncologists, Life Tech is working with lung cancer advocacy organizations to increase awareness of the importance of molecular testing for lung cancer patients.

Life Tech is still awaiting state regulatory approval to market the test in Florida and New York, but as commercialization plans are progressing, the company is simultaneously working on adding to the evidence backing the clinical validity and utility of the test.

According to Dave Daly, head of oncology at Life Tech, the company has initiated a prospective clinical trial to demonstrate whether patients deemed by Pervenio to be at high risk of lung cancer progression will benefit from adjuvant chemotherapy. The firm plans to enroll 1,500 patients in this global trial.

"This landmark study will add significant predictive value to the existing prognostic indications for the test," Daly said. "Additional studies will be conducted as we continue to demonstrate the value of the test on positively impacting patient care for early-stage NSCLC patients."

In another study presented last month at the annual meeting of the Society of Thoracic Surgeons, researchers from the University of California, San Francisco, and elsewhere reported that the test can identify which patients with small but aggressive tumors are at heightened risk of death.

In the validation study, researchers led by UCSF's Johannes Kratz enrolled 269 patients who had received surgery to remove NSCLC tumors that were smaller than 2 cm that had not yet spread to the lymph nodes. Overall survival was 83 percent for patients predicted to be at low risk, 69 percent for patients in the intermediate risk category, and 52 percent in the high-risk group. Results were similar for patients who had had tumors 1 cm or smaller resected.

The American Lung Association recommends that former smokers between age 55 to 74 years, with a smoking history of 30 pack years or more and no history of lung cancer should be screened for lung cancer via low-dose computed tomography screening. While this type of screening is likely to identify many lung cancer patients with small, aggressive tumors of 2 cm or less, not everyone with these tumors will be at high risk of dying from their disease after surgery.

This is where Pervenio might be able to help guide treatment strategies, Life Tech is hoping, by identifying patients with small, aggressive tumors who are at risk of dying from NSCLC despite having had the tumor surgically removed. With a better idea of which patients are at higher risk of having a poor outcome due to their cancer, doctors can make more informed decisions about whom to treat with chemotherapy.

"A recent analysis of the JBR.10 trial of adjuvant therapy in early-stage patients supported the conclusion that high-risk patients identified by prognostic gene signatures benefit from adjuvant chemotherapy," Kratz and colleagues wrote in their abstract. "The reliable identification of T1a node-negative patients at up to 50 percent risk of mortality by this practical molecular assay may result in the best chance of maximizing the benefit of early detection of these tumors through low-dose CT screening."

To date, Pervenio has been validated on close to 1,800 patient cohorts, from UCSF, Kaiser, and the China Clinical Trial Consortium. However, currently available evidence on the test wasn't sufficient for Medicare to cover the test through Palmetto GBA's MolDx program.

Palmetto "has determined that Pervenio Lung RS, an assay formerly known as Pinpoint Dx Lung, has insufficient evidence to support the required clinical utility for the established Medicare benefit category," the Medicare contractor said in a Jan. 7 decision. "Therefore, the Pervenio service is a statutorily excluded service."

Daly said that Life Technologies is in discussions with CMS and MolDx program officials to gain a better understanding of the types of evidence required for a positive coverage decision. The company plans to provide an update in this regard later in the year.