One year after it released an array-based in vitro diagnostic for periodontal disease, Greiner Bio-One plans to stake a new claim in the European IVD market by launching an in vitro diagnostic for cervical cancer.
According to Jörg Stappert, product manager at Greiner Bio-One, the Frickenhausen, Germany-based company plans to release PapilloCheck, a microarray-based IVD for cancer of the cervix, by the fourth quarter.
Stappert said that the array can detect 24 different variations of human papillomavirus, a sexually transmitted virus that can cause cervical cancer, and is designed to classify strains of the virus into 18 high-risk and six low-risk types.
Stappert said that he has no definite numbers on the size of the global market for an IVD for HPV, but said that "millions of tests a year are performed worldwide."
He acknowledged that Greiner will have ample competition when it enters the market, specifically from Digene and Roche Diagnostics, both of which sell HPV detection kits. However, he noted, "neither are array based." Digene's Hybrid Capture System, which is available in the US, can detect papilloma virus in patients, but is PCR-based, as are Roche's HPV Assays.
Stappert said the array-based test would provide more sensitive analysis, be easier to operate, and be more cost-effective than its PCR-based rivals.
Clinical validation studies of the PapilloCheck test are currently underway at Germany's University of Tuebingen, according to Stappert.
"[The validation] is starting now and hopefully [the process will] be finished by the end of this year," Stappert said. He added that Greiner is assembling the necessary documentation to file for a CE Mark from the European Union.
Stappert said that once PapilloCheck receives its CE Mark, Greiner "would start to launch [PapilloCheck] in other countries."
Greiner Bio-One has already had one of its array-based IVDs approved in Europe. The company's ParoCheck, launched in early 2004, received its CE Mark that year after undergoing clinical validation studies at the Universities of Bonn, Marburg, and Aachen.
Stappert told BioArray News this week that several medical institutes are using ParoCheck to analyze periodontal samples from dentists to identify gingivitis-related pathogens in their patients. Dentists can then use that information to prescribe better treatment for their patients, according to Stappert.
These institutes run around 60,000 to 70,000 samples per year on the ParoCheck platform at a cost of €50 to €70 per sample.
Greiner last year also released CarnoCheck, an array-based test for identifying eight different animal species — horse, donkey, cow, pig, goat, sheep, turkey, and chicken — in foodstuffs. The company's main client for CarnoCheck is the German government, which requires that all foodstuffs undergo testing to prevent mislabeling. Stappert said that Greiner had no plans of marketing CarnoCheck beyond Europe.
Even with customers like the German government and the medical clinics that run ParoCheck, Stappert said that PapilloCheck has the greatest commercial potential out of the trio of array-based tests.
US Market Launch Date Still in the Air
While ParoCheck already has its CE Mark, and PapilloCheck may earn its European approval by the end of 2005, Greiner has yet to move either towards the US market.
So far, according to Jan Seldin, Greiner's US product manager, the only biochip inventory stocked at Greiner's US headquarters in Lakewood, Fla., are its one- d 12-welled Highest-Throughput Arrays (HTA), which were released commercially in early 2004. [see BAN 2/11/2004]
Still, Seldin said that the company has just begun to stock up on the HTA1 and HTA12 arrays.
"We just now are bringing them over," Seldin said.
Stappert said that Greiner is assembling the documentation to seek approval from the US Food and Drug Administration for ParoCheck and PapilloCheck, despite the fact that the process is "difficult" and "different."
"We haven't filed for FDA approval, but we'll do it," Stappert said. The process would most likely begin after PapilloCheck gets its CE Mark, sometime in 2006.
Lambda's Curtain Call
While Greiner already has two array-based IVDs in its back pocket, as well as a food-identification test and high-throughput microfluidics-based assays, its venture into the microarray market is actually quite young.
According to Stappert, the company first started eyeing the market for arrays in 2001 when it collaborated with Lambda, a Friestadt, Austria-based biochip company, for what would become the ParoCheck IVD. [see BAN 1/18/2002]
Greiner bought the firm in 2003, and now Lambda is a wholly owned subsidiary of the larger biotech company. According to Wolfgang Kranewitter, the project leader at Lambda, much of the technology going into the new Greiner IVDs is actually older Lambda technology.
"It is our own technology," said Kranewitter. "Greiner produced the slides for the DNA chips."
Stappert and Kranewitter said that the two companies are now, two years after their combination, nearing complete integration.
Stappert said that Lambda would cease to operate under that name by the end of 2005, and that it would continue to operate as one of Greiner's many subsidiary offices.