Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the testing industry. Sepsis test maker T2 Biosystems had a busy week, revealing promising study results for its bacteria panel. Lab giant Quest Diagnostics snatched up Clinical Laboratory Partners' outreach laboratory service business to expand its testing footprint. And yet another company jumped into the fast-growing liquid biopsy market, as Circulogene Theranostics launched cell-free DNA tests for cancer monitoring. Read on for the details. And as always, feel free to contact us with any questions or comments. -- Emily Wasserman (email | Twitter)
T2 Biosystems reveals positive results for sepsis bacteria test
T2 Biosystems ($TTOO) recently unveiled promising findings for its T2Bacteria Panel test, with a new study showing that the tool could rapidly pinpoint 6 sepsis-causing bacteria from smaller samples of whole blood, or less than 10 CFU/mL, eschewing the need for a blood culture. The Lexington, MA-based company has already shown that its T2Candida test can identify bacteria with 91.1% sensitivity and 99.4% specificity with a limit of detection as low as 1 CFU/mL, all in less than 5 hours. So the latest findings put T2Bacteria on par with T2's flagship test, setting the stage for more growth for the product in the months ahead.
"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for a blood culture," T2 CMO Dr. Mike Pfaller said in a statement. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives." Statement
Quest Diagnostics inks deal with Connecticut labs services provider
It's been a busy month on the dealmaking front for Quest Diagnostics ($DGX), and in its latest move the company is snatching up Connecticut healthcare provider Hartford HealthCare's (HHC) outreach lab service business. Neither side is revealing financial details, but under the terms of the deal HHC's Clinical Laboratory Partners (CLP) business will transfer its lab testing to three of Quest's clinical labs in Connecticut and one in Massachusetts, giving Quest a stronger foothold in the region. Madison, NJ-based Quest will also get its hands on "other select assets" and several of CLP's patient service centers as part of the deal.
This is not the first time Quest and CLP have worked together. Quest already runs high-end reference testing for CLP and 5 of HHC's affiliated hospitals. The deal is meant to build on this rapport, giving patients more access to testing in the state and providing more tests, including sequencing tools for cancer, neurological disorders and other diseases, the pair said in a statement. Further down the road, the partners could draw on Quest's lab data to "explore opportunities to collaborate in population health and data analytics," the two said, two areas where Quest is making strides.
"Top health systems that have developed a commercial outreach business, such as Hartford HealthCare, are increasingly entrusting the vital diagnostic information service to Quest because we have unique assets, such as clinical expertise and scale, which allow us to deliver great value," Quest CEO Steve Rusckowski said in a statement. "We look forward to continuing to serve Hartford HealthCare and to inspiring better health through diagnostic insights for individuals and families in Connecticut." Release
Circulogene Theranostics jumps into liquid biopsy space with finger-stick test rollout
It seems like everyone is diving into the liquid biopsy space these days, with startups and big companies looking to cash in on the rapidly growing market. But few companies offer the promise of tools that use small blood samples to screen for tumor DNA--and that's where Circulogene Theranostics comes in.
The Birmingham, AL-based company is launching its cell-free DNA (cfDNA) liquid biopsy tests for 10 tumor types including breast, lung and colon cancer. The tools, which screen for circulating cfDNA from a single drop of blood, allow doctors to plan and monitor treatment after a patient gets a cancer diagnosis. Circulogene is touting its finger-stick technology as faster and more cost-effective than standard liquid biopsy testing, as the tools can pick up on 100 times more cfDNA with as little as 20 microliters of blood and offer results in as few as 7 days instead of weeks or months, the company said in a statement.
"Our science team is pioneering the next generation of liquid biopsy cancer management: tumor monitoring from droplet volumes of blood. No one else is doing that," Circulogene CSO Chen-Hsiung Yeh said in a statement. "When combined with next-generation genomic sequencing, we have an unprecedented laboratory diagnostic test platform for improving cancer management." Statement