The Story Continues To Be Written

Gone are the days of one-size-fits-all medicine. Today, the pipeline of targeted therapies for a range of complex diseases is rapidly expanding with more than 300 precision medicines currently available (1). Access to these new therapies can make all the difference in patient outcomes, particularly when it comes to hard-to treat cancers that may otherwise have limited treatment options. To match patients with these promising treatments, a companion diagnostic test (CDx) is required. CDx tests help identify whether a patient is an appropriate candidate for a particular targeted therapy based on their tumor’s genetic profile. Historically, this testing used to be done looking at a single biomarker at a time. Today, next-generation sequencing (NGS) allows for the simultaneous evaluation of multiple genes, delivering results in as little as 24 hours.

Thermo Fisher Scientific, with its Ion Torrent sequencing platform and Oncomine assays, is one of the key players in this field. We sat down with Jane Li, Senior Director of Oncology, Pharma and CRO Partnerships to learn more about this era in companion diagnostics.

Thermo Fisher’s Oncomine Dx Target Test* was the first NGS-based companion diagnostic approved by the US FDA in 2017 (2). Could you tell us about the advancements since the first approval?
 

Since 2017, we have been focusing on expanding the indications and access to our CDx test. We have received regulatory approvals for nine CDx biomarkers for 17 therapies on label, for non-small cell lung cancer (NSCLC) as well as thyroid cancer and cholangiocarcinoma. The test, with different indications per local regulatory approval, is now available in 18 countries across the globe. And we continue expanding further, working with both current and new pharma partners.

What is the most recent news?
 

Last year we launched in Europe the Oncomine Dx Express Test **(3), an in vitro diagnostic (IVD) CE marked test that is used with the Genexus Dx System to deliver clinically relevant tumor mutation profiling in as little as 24 hours utilizing a highly automated workflow from both formalin-fixed, paraffin-embedded tissue and liquid biopsy samples. This year we’ve continued registering the solution in a number of Asia-Pacific countries. For example, last month it was approved in Malaysia.

Our focus now is working with our partners on new, rapid CDx tests using the Oncomine Dx Express Test. This will enable more labs to bring the power of genomic testing in-house, closer to the patients, and thus improve the access to the new targeted therapies 

Recently, we announced a partnership with Boehringer Ingelheim (4) to develop CDx tests to help identify a subset of patients with NSCLC for targeted therapy treatment. This partnership aims to develop multiple CDx tests, based on the Oncomine Dx Express Test, to help ensure labs will have the ability to match eligible patients with emerging NSCLC treatments as they become available.

What opportunities do you see for further expanding access to companion diagnostics?
 

Companion diagnostics can be co-developed alongside targeted treatments through clinical trials as the primary CDx, or after a therapy has been marketed as a follow-on CDx. They are ideally approved at the same time as a targeted therapy and launched simultaneously to ensure patients can access the new treatment’s benefits right away.

However, developing additional so-called “follow on CDx” tests can provide more options, particularly as new, improved diagnostic technologies are made available, and expand access to testing.

We are currently working with multiple pharma partners on “follow on CDx tests”. For example, this year we announced a partnership with AstraZeneca (5) to develop solid tissue- and blood-based CDx tests for osimertinib. While this drug is currently approved in numerous countries and regions around the world with a single gene PCR-based test, NGSbased CDx tests may, in future, further improve patient access.

Also, last month we announced a new submission to regulatory authorities in Japan with a MET exon14-skipping mutation CDx test for capmatinib, in partnership with Novartis. This drug was originally approved in Japan with FoundationOne^®CDx as the CDx, however, the patient access to this drug was compromised, by unavailability of Foundation Medicine service in Japan.

Where do you see the role of liquid biopsies in companion diagnostics?
 

The role of liquid biopsies is becoming increasingly significant, as they are less invasive than tissue biopsies. They make molecular testing possible when tissue is not available, which is often the case, especially in NSCLC. Pharmaceutical companies are recognizing this opportunity and are looking for diagnostic partners who can develop liquid biopsy tests that can be implemented in a broad spectrum of labs.

The Oncomine Dx Express Test provides the ability to analyze both tissue and liquid biopsy samples and the partnership with AstraZeneca will also leverage this feature.

In addition, we are working with two more partners on developing tissue and liquid biopsy CDx tests to identify patients with EGFR exon 20 inser tion mutations who may be eligible for the respective targeted therapies.

Are you planning to expand the CDx indications beyond the NSCLC?
 

Yes, of course; whilst NSCLC continues to be the most active space with regards to new therapy developments, we are increasingly seeing new drug trials outside of lung indications.

The Oncomine Dx Express Test covers relevant genes and variants across numerous solid tumor types, including NSCLC, breast, melanoma, colorectal, and thyroid, amongst others, and we are already discussing new projects outside of the lung indication.

So when do you think we are going to hear more news?
 

Soon. In addition to the aforementioned projects, we are also preparing Oncomine Dx Express Test submissions to the US and Japan authorities, as well as in vitro diagnostic regulation (IVDR) registration.

It is our mission to make the rapid CDx testing available worldwide as soon as possible, to empower clinicians to choose the most appropriate treatment for their patients.

Learn more at www.oncomine.com/pharma

^{* For In Vitro Diagnostic Use
** For In Vitro Diagnostic Use. CE-IVD according to IVDD. Not available in all countries including the United States.}

^{Abbreviated Intended Use: The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology, the Ion Torrent Genexus Dx System to detect deletions, insertions, substitutions and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalinfixed, paraffin-embedded (FFPE) tumor tissue samples. Oncomine Dx Express Test also detects deletions, insertions, substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples.}