Tony Fong is managing editor for 360Dx, GenomeWeb's news site on the in vitro diagnostics market.
The firm anticipates receiving regulatory approval from the CFDA for its first three products by the end of the year, including one for lung cancer.
Winship's director of the cancer tissue and pathology shared resource said that some labs aren't leveraging molecular technologies due to reimbursement issues.
With PAMA scheduled to be implemented in January, many believe M&A in the clinical lab space will heat up, with Quest and LabCorp the main beneficiaries.
While molecular testing is now routine in cancer and women's health, for other disease areas, the technology may be overkill, Sundin said.
The three-year-old firm anticipates entering the clinical space later this year with a launch of its metabolomics-based test in Finland.
The test addresses a major challenge of using an immunoassay for diagnosing Zika — the inability to differentiate it from other flaviviruses.
The loan from Grand Challenges Canada will be used to support Atomo's business operations.
The company has started a clinical validation study for a PSA test running on the Claros 1 platform and expects to file for a PMA later this year.
The vice president of clinical programs at ACP discusses what's happened in the five years since a report made recommendations on how to cut down on unnecessary testing.
At issue is the lack of reference samples for evaluating the performance of LDTs that may determine which patients are appropriate for specific cancer drugs.