Guardant and Janssen in Partnership for Companion Diagnostic

Guardant Health is in a partnership with Janssen Biotech to pursue regulatory approval for a companion diagnostic to amivantamab, an investigational biospecific antibody poised to treat non-small cell lung cancer.

The Redwood City, CA-based company’s Guardant 360 CDx is at the center of the collaboration with Janssen. As it stands now, the Guardant360 blood test is increasingly being used to guide treatment in metastatic cancer, as the number of treatment-relevant genomic alterations continues to grow.

Raritan, N.J.-based Janssen’s amivantamab is in clinical trials and targets activating and resistant EGFR and MET mutations and amplifications.

“Studies continue to show that the full promise of personalized medicine remains out of reach for the majority of patients with advanced non-small cell lung cancer who are not receiving complete genotyping before starting therapy, thus impeding their treatment with the most appropriate therapy,” AmirAli Talasaz, PhD., Guardant Health President, said in a release. “Our Guardant360 liquid biopsy has been shown to overcome the barriers associated with tissue, and increase genotyping rates, which we believe will ultimately help ensure that all patients who are eligible for potentially life-changing therapies are identified from the start.”

Guardant has been making progress with its 360 liquid biopsy offering outside of its newly announced partnership with Janssen. This includes trying to secure a PMA for the liquid biopsy test.

Daniel Simon spoke with MD+DI about the company’s progress in securing approval. Simon is responsible for building Guardant’s partnerships with pharmaceutical and biotechnology companies using the Digital Sequencing technology platform. He brings more than a decade of experience in the life sciences industry across business development, strategy, and operations. 

“[Approval] for Guardant360 is a work in progress,” Simon told MD+DI. “The assay launched as a laboratory-developed test back in 2014. We announced that we had submitted a PMA for the test on our [3Q19] earnings call. We have breakthrough designation and FDA has been wonderfully and impressively actively engaged. We are making good progress with that first approval.”  

Simon said the company hasn’t put anything out publicly about when approval for the Guardant360 test is expected.

COVID-19 lies in the backdrop of the company seeking approval and the Janssen companion diagnostic collaboration. However, Simon noted there haven’t been any disruptions because of COVID-19.  He went on to say the coronavirus has reinforced the importance of liquid biopsy tests.

“I think more importantly, given the restrictive access that many patients have had during this time – because of COVID-19 – has reinforced some of the benefits of liquid biopsy for a lot of patients,” he said. “We’ve always used mobile phlebotomy. But the fact during this time we’ve been able to send the nurses who do mobile blood collection to a patient’s homes and spare them the risk of further exposure … has been a huge bonus.”