June 19, 2019

NEW YORK (GenomeWeb) – Qiagen said Wednesday after the close of the market that that it has signed an agreement with McKesson Medical-Surgical, an affiliate of McKesson, to serve as the exclusive distributor of the QiaStat-Dx syndromic testing platform in the "acute" market segment of US hospitals with 200 or fewer beds.

The agreement also makes McKesson a non-exclusive distributor for QiaStat-Dx's future expansion into clinics located in US retail pharmacies.

Qiagen said it will continue its sales and marketing efforts in larger hospitals and clinical laboratories.

The QiaStat-Dx system and its first test, a multiplex respiratory pathogen panel, received 510(k) clearance from the US Food and Drug Administration in May. The automated system uses multiplexed real-time PCR and can detect as many as 48 targets simultaneously, enabled by a proprietary microfluidic test cassette design and a six-wavelength optical sensor.

Qiagen acquired the technology along with Spanish molecular diagnostics company Stat-Dx in early 2018 for up to $191 million. The company is developing other panels for the system, including a gastrointestinal pathogen panel slated to launch later this year.

Qiagen said that the small-hospital segment that McKesson will target represents about one-third of the estimated 6,000 hospitals in the US and about 10 percent of the current US market for syndromic testing, which overall is estimated at $650 million annually. The company believes that US hospitals in the acute market will run approximately 750 respiratory tests per year on average, making the total addressable market for syndromic testing in the market about 1.5 million tests per year.

"McKesson has a very powerful commercial reach, strong relationships, and experience in both the acute segment of smaller US hospitals and the non-acute setting in retail clinics," Qiagen CEO Peer Schatz said in a statement. "We believe that working with McKesson will accelerate placements for QiaStat-Dx among US customers for syndromic testing as we can cover segments that have previously not been in focus for our teams."