This story has been updated from a previous version posted on Feb. 9 to include additional comments from DNA Link and Affymetrix.
A new array-based test could aid in identifying the remains of thousands of unknown soldiers from the Korean War.
Jong-Eun Lee, CEO of DNA Link, told BioArray News that the test, called AccuID, is already available through the firm's laboratory in Seoul, South Korea.
According to Lee, DNA Link's forensic testing service relies on a custom targeted resequencing array manufactured by Affymetrix. AccuID has been developed for human identification purposes, Lee said, adding that its "most useful application" is for genotyping highly degraded samples, such as old bones.
In particular, he said that DNA Link is focusing on the remaining cases of unidentified Korean War casualties to and find living relatives so that the soldiers' remains can be returned to their families. Fought between 1950 and 1953, the Korean War is estimated to have claimed between one and two million lives. Lee said that about 130,000 Korean soldiers are still missing from the conflict, and the Korean Department of Defense has located the remains of about 7,000 of those war casualties.
Currently, the Korean DoD is using short tandem repeat-based method to identify those remains by matching them with living relatives of those missing soldiers, but the matching rate is "extremely low" due to the condition of the DNA, Lee said.
DNA Link is in the process of persuading the DoD to adopt its chip for that program.
"We have some good preliminary results using other old DNA and their living relatives," Lee said. He noted that the Korean program is focused on Korean soldiers, and that cases involving US soldiers are handled by the US Department of Defense. About 8,000 American servicemen who fought in Korea are still listed as missing by the US DoD.
A self-described medical genetics research company, DNA Link provides services for several US and European vendors, including Affy, Agilent Technologies, Fluidigm, Illumina, Pacific Biosciences, and Roche. Earlier this week, the company announced that it had obtained a license to develop and commercialize a microarray-based forensic test on Affy's GeneChip platform.
In Lee's opinion, microarrays have "many advantages" over other technologies, including PCR-based microsatellite genotyping, Fluidigm's integrated fluidic circuit-based approach, and genotyping by sequencing.
With regards to microsatellite, or STR, genotyping, Lee said that SNP markers are "easier to type, interpret, and scale up" compared to STR markers.
"We have data that shows many SNP markers being genotyped by our chip on the samples [that] were unable to [be] genotyped with existing STR marker kits," said Lee.
He added that DNA Link selected an array-based approach over adopting next-generation sequencing for its forensic test because it "requires less DNA" and because Affy's arrays are "quite reliable and easy to make in large quantities."
He also noted that Affy's installed base of GCS 3000Dx v.2 instruments around the world was a rationale for making the test available as a GeneChip, as those interested in using AccuID "don't have to invest in machines."
Though the 3000 Dx has been cleared by the Korean Food and Drug Administration, Lee said that forensic tests like AccuID do not require regulatory clearance in South Korea.
From Affy's perspective, the launch of AccuID is a gateway to the Korean market for its diagnostic partners.
Mindy Lee-Olsen, vice president of marketing services at Affy, told BioArray News that the firm maintains similar relationships with 16 diagnostics firms — including Roche, Pathwork Diagnostics, and Skyline Diagnostics — that have developed and launched tests on Affy's technology platform (BAN 6/26/2012). In total, 60 tests have been developed or are in development, Lee-Olsen said.
According to Lee-Olsen, the addition of DNA Link, a service provider that offers testing on the 3000 Dx v.2, could technically enable those firms to eventually offer their tests to Korean customers.
"In the event of DNA Link, there are no formal agreements at this time that name them as a menu integrator [or] test outlet, but it is a possibility down the road," Lee-Olsen said.
Such relationships could expand the market for DNA Link's test too.
Lee said that his company is "absolutely interested" in providing DNA Link's chips to partners in other countries, and noted that the company selected SNP content for AccuID that would allow the test to "perform well on other ethnic groups."
Looking ahead, Lee said that DNA Link is planning a new version of AccuID that will feature additional markers including "ancestry informative markers for ethnic differentiation, phenotype markers like ABO blood type," and markers for hair and eye color. He said that DNA Link is working with Affy on the next version of the chip.