Report: House panel led by Waxman now investigating genetic testing kits
WASHINGTON Federal scrutiny over at-home genetic testing continues to snowball in the wake of an abortive plan by one testing kit supplier to sell the products through the nation’s two largest drug store chains. Both chains, Walgreens and CVS/pharmacy, last week temporarily suspended their plans to begin offering kits produced by Pathway Genomics Corp. after the Food and Drug Administration raised concerns about the efficacy and approval procedure for the test.
In the latest development, the House Energy and Commerce Committee has begun looking into personal genetic testing kits sold online, according to a report Wednesday from Dow Jones news service. The committee and its chairman, California Democratic Rep. Henry Waxman, are asking Pathway and two other kit makers, 23andMe Inc. and Navigenics Inc., to provide information about the test and the accuracy of its results, Dow Jones reports.
All three companies sell the saliva-based kits online, and provide lab analysis of the results for a fee. But press reports last week about Pathway’s plan to sell the kits at retail triggered new attention from the FDA, which announced that the kits aren’t FDA-approved. Concerns raised by the agency prompted both Walgreens and CVS to suspend plans to sell the products until those issues were resolved.
Pathway has claimed that the test kits don’t fall under FDA approval requirements, but said it is working with the agency to resolve the issue.
MinuteClinic opens two Mass. locations
WOONSOCKET, R.I. MinuteClinic, which is owned by CVS Caremark, has expanded its Massachusetts-based clinics to 20 with Wednesday’s opening of two new locations in Hanover and Quincy.
"Since opening our first store-based clinic in Massachusetts in 2008, we have helped to expand access to high-quality, convenient and affordable care to thousands of residents who have visited us at convenient CVS/pharmacy locations near where they live and work," stated Andrew Sussman, president of MinuteClinic and SVP/associate chief medical officer of CVS Caremark. "We are committed to working with the medical community in Massachusetts to build on the state’s precedent-setting efforts to broaden access to quality health services."
According to MinuteClinic, it has had more than 50,000 patient visits in Massachusetts (not including flu shot visits) in less than two years. About 70% of the patients seen at MinuteClinic locations in Massachusetts do not identify a primary care provider. MinuteClinic offers those patients without a primary care provider information on nearby practices accepting new patients.
Hospira extends acquisition offer to Javelin
LAKE FOREST, Ill. Hospira has extended its $145 million offer to buy Javelin Pharmaceuticals, the generic drug maker said Wednesday.
The offer, originally made in April, was set to expire at the end of Tuesday, but will now expire at the end of June 2.
Hospira said Javelin had not satisfied all the conditions for acquisition, which Javelin said was due to a supply-chain problem with the painkiller Dyloject in the United Kingdom, though Javelin expressed disagreement with Hospira’s position.