Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Veritas Genetics launched a $999 whole genome sequencing service that can run on a smartphone. Chembio Diagnostics is teaming up with a Brazilian biotech organization to develop point-of-care Zika tests for the country. Last but certainly not least, Cepheid got an FDA OK for its superbug test. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)
Veritas Genetics rolls out lower-cost whole genome sequencing service
As the personalized medicine trend takes off, more healthcare providers are relying on whole genome sequencing for insights on patients' genetics. But cost has traditionally hampered this process. Veritas Genetics is trying to change the norm with a new service that makes whole genome sequencing more accessible and affordable to the masses.
The Cambridge, MA-based company's platform, which is priced at $999, can run on a smartphone app and includes a genetic counseling service with on-demand video conferencing. Veritas is planning on launching the tool in April. Eventually, it could replace other genetic tests because it provides more comprehensive answers about a person's genome.
"The whole genome is the new standard," Veritas CEO Mirza Cifric said in a statement. "At this price point, there is no reason to use anything but the whole genome, especially for any tests that are close to or more than the price of our whole genome."
Still, the company could face some regulatory hurdles as it charges ahead with its service. The accuracy of the data Veritas offers is less than some of the more targeted genetic tests, The MIT Technology Review points out.
The company is requiring a doctor to order a test for patients, which helps it avoid the agency's strict rules for "direct-to-consumer" DNA tests. But the move could also bring the company under regulatory scrutiny, especially as it runs the service on a consumer-facing app. Statement (PDF) | Story
Chembio Diagnostics joins with Brazil biotech organization to develop Zika test
Chembio Diagnostics ($CEMI) got in on Zika test development early, recently scoring a grant from the Paul G. Allen Family Foundation to create a point-of-care (POC) diagnostic for the virus. Now the company is working with Brazilian biotech organization Bio-Manguinhos/Fiocruz to make POC Zika tests for the country, where the epidemic rages on.
The partnership builds on the pair's earlier work. Chembio and Bio-Manguinhos have already developed POC diagnostics for a range of conditions including HIV and syphilis. The latest effort comes at a critical moment, as Zika cases continue to rise and health experts call for quick tests that can spot the virus earlier.
"Preliminary testing results are highly encouraging and our ongoing collaborations with Bio-Manguinhos/Fiocruz and the global scientific community are extremely helpful as we move toward a rapid and affordable solution," Chembio CSO Javan Esfandiari said in a statement. Release
Cepheid gets FDA blessing for quick superbug test
Cepheid ($CPHD) got an FDA green light for its rapid in vitro test for superbug infections. The test can pinpoint common drug-resistant bacteria in less than an hour, which could potentially stave off superbug outbreaks.
The FDA blessing comes at a critical moment. Superbug infections are proliferating at U.S. healthcare centers, and a recent study from the Centers for Disease Control and Prevention cited drug-resistant bacteria as an urgent threat to human health. The bacteria can be easily transmitted, which often leads to "well-documented outbreaks" associated with disease and in some cases, death, Cepheid CMO Dr. David Persing said in a statement.
Cepheid is trying to address the problem head-on with its Xpert Carba-R test. The tool requires less processing time and can pick up on potentially harmful bacteria in a wide range of specimens including blood cultures and urine.
"Now, with a bacterial isolate and less than a minute of hands-on time, Xpert Carba-R delivers a result in under an hour, allowing timely detection and differentiation of the most prevalent carbapenemase genes associated with [carbapenemase producing organism] outbreaks to support infection control efforts," Persing said. More