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With 510(k) Clearance for 3500 Dx, Life Tech Aims to Convert HLA Typing Customers to Cleared Box, Assay


Life Technologies said this week that the US Food and Drug Administration has cleared its SeCore HLA typing assay and its 3500 Dx Genetic Analyzer, a Sanger sequencing instrument, for diagnostic use. The 510(k) clearance is a first for a sequencing system and sequencing-based assay, and the company's president of medical sciences, Ronnie Andrews, said that it "validates Life's move into diagnostics" as the company aims to bring additional products, such as its QuantStudio Dx real-time PCR system and Ion Torrent PGM, through 510(k) clearance.

Andrews added that the company would spend the next six months working with existing HLA typing customers to convert their research-use-only assays to the FDA-cleared versions.

"We'll make every effort that we can to make these diagnostic kits available to our current customer base in terms of ways to create creative programs to allow them to move into the diagnostic box versus the current RUO box," he said. "Our goal is to do that globally to all the transplant centers that are currently our current customers."

The new products will command a higher price, Andrews said, because the company has already spent between $5 million and $7 million over the last three years on the FDA submission, not including research and development costs. "That's typically what a submission of a system costs," he said. "We will want to extract the value that we've now created and recoup some of the expense we've invested."

He did not specify by how much the price of the system would increase.

The company will continue to produce research-use-only versions of its 3500 system. The main differences between the systems are that the diagnostic version has different built-in software as well as quality control capabilities. It also has the ability to track reagent use with radio frequency identification tags.

Also, all of the systems for diagnostic purposes will be manufactured in the company's Singapore facility, which has been certified by the International Standardization Organization and is compliant with the FDA's Good Manufacturing Practice guidelines. "It's the highest bar quality from a manufacturing perspective," Andrews said.

The HLA assay itself covers six genes within the major histocompatibility complex, including the Class I genes HLA-A, HLA-B, and HLA-C, as well as the Class II genes DRB1, DQB1, and DPB1.

The company will design separate tests for each gene, which will cost between $30 and $50 each, depending on the gene and the size of the kits ordered. Kits are sized at 25 tests per kit and 500 tests per kit.

While the SeCore HLA kit is the first FDA-cleared Sanger-based product for HLA typing, there are other FDA-cleared products for HLA typing based on sequence-specific primer designs and PCR. However, according to Zahra Kashi, CEO and clinical lab director of Portland, Ore.-based Kashi Clinical Laboratories, one advantage of using Sanger sequencing over PCR is that it is less labor intensive and also higher resolution.

A PCR-based approach requires the user to create sequence-specific primers, which is "very laborious and time consuming," she said. Additionally, she said, sequencing gives a higher resolution, so for applications like bone marrow transplants it would be preferable over other methods.

Going forward, she anticipates that labs that are looking to bring in sequencing will choose to have an FDA-cleared kit. However, she did not think that labs already running an FDA-cleared PCR test would necessarily switch to the sequencing kit.

"Sequencing is done based on the need of the lab and what program they're supporting," she said. For labs running a cleared test for applications that do not require as high as resolution as sequencing can yield, there is not necessarily an incentive to switch.

Kashi's laboratory was one of three centers that conducted the clinical trials for Life Tech's FDA submission.

She said the trials involved comparing Life's sequencing kit to an FDA-cleared PCR kit, running the two tests in parallel to compare the outcomes, which was done for about 100 different samples. She said the lab also did reproducibility studies of a set of different samples, making sure that the tests produced the same results on separate 3500 Dx sequencing systems, and the same results in different labs run by different technicians.

Kashi anticipates that regulatory agencies will eventually require all HLA typing tests to be FDA cleared. "It's been an ongoing debate for a while now," she said. Currently, labs offer sequencing-based tests as laboratory developed tests under CLIA, but Kashi expects that eventually these labs will be required to offer the FDA-cleared version.

"For incumbent labs that are using non-FDA cleared kits, the question is whether or not they will be making the switch, and if so, how soon? It will all depend on the regulatory environment and the expectations of the regulatory agencies," she said.