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Clinical Genomics Planning Wider Launch of Colvera After Piloting in Local Markets

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NEW YORK (GenomeWeb) – Clinical Genomics said this week that after seeing early success with a limited commercial roll out of its epigenetic colorectal cancer recurrence test Colvera that began in January, it now plans to launch the test more broadly this summer.

Unlike many genomic approaches now being advanced for blood-based cancer detection by companies like Guardant Health, Foundation Medicine, and more, Colvera is relatively simple: designed to detect the presence of epigenetic modifications of two genes — BCAT1 and IKZF1 — using PCR technology and reagents from Qiagen.

In a webinar sponsored by Qiagen this month, Clinical Genomics President and CEO Lawrence LaPointe highlighted the test's more prosaic approach in comparison to firms that have taken much of the liquid biopsy spotlight.

The assay is designed for a specific clinical niche, and with a simple proposition — that it outperforms the current gold standard for monitoring colorectal cancer patients after surgery.

For example, in a study published last fall in Cancer Medicine, company researchers concluded that Colvera picks up about twice the number of colorectal cancer recurrences as currently used blood tests that measure levels of carcinoembryonic antigen (CEA).

LaPointe said in an interview this week that focusing on this simple question has helped the firm persuade clinicians to adopt the assay as it has been rolled out over the last four months with a select group of early customers — mainly on the East Coast. The firm is based in Sydney, Australia but has US offices and laboratories in Edison and Bridgewater, New Jersey.

"We provide doctors with very simple actionable data: ctDNA is present, so we should treat that patient as having evidence of cancer recurrence," he explained.

"We started a soft launch in January and began rolling out our sales team and had most of those folks on board in March … [and] the feedback has been great, so we decided to go for a more aggressive launch in July," LaPointe said.

The company has 10 sales reps, he added, covering 27 states, mostly on the East Coast.

According to LaPointe, Clinical Genomics is certified to provide testing to patients from 47 states through its Bridgewater CLIA lab, but hasn't yet secured approval for testing in New York, Florida, and California.

Because Colvera is still early in its implementation, there isn't data yet that speaks to the test's potential or actual impact on patient outcomes.

In the webinar earlier this month, LaPointe cited publications over the last several years showing that CEA testing, when it works, can improve outcomes. With data in hand showing that Colvera significantly outmatches CEA in sensitivity, the company is in a position to argue that it should also positively affect mortality or other endpoints, at least as much, if not more than CEA.

As is true across the genomic testing space, especially with newer liquid biopsy technologies, locking in reimbursement is an uphill climb. LaPointe said that Clinical Genomics has been in conversation with payors, though these interactions are still early.

The company announced in March, though, that it has signed agreements making Colvera available to patients in two preferred provider organization plans — Fortified Provider Network and MultiPlan.

Colvera's list price is $449 dollars, which the company believes is defensible in terms of both cost effectiveness and cost benefit to doctors and patients, LaPointe said in an interview.

Questioners following LaPointe's webinar presentation were curious about whether the company is pursuing other uses for Colvera, apart from the specific setting of post-surgery monitoring.

Early detection or screening in undiagnosed patients is not something that Clinical Genomics has in mind for the test, LaPointe said. There are already both stool- and blood-based tests for this niche — namely Exact Sciences' ColoGuard fecal test and Epigenomics blood-based Epi proColon.

However, LaPointe said that minimal residual disease testing as a method for assessing patient response to specific therapies is something the company is investigating, though it hasn't published anything supporting that yet.

Others in the liquid biopsy field have targeted this area for test development as well — showing, for example, that by sequencing colorectal cancer patients' tumors, they could identify individual mutations that predict imminent or incipient recurrence.

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