Tony Fong is managing editor for 360Dx, GenomeWeb's news site on the in vitro diagnostics market.
Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.
There were 58 M&A deals in the diagnostics space during the year, paced by Quest, which announced 12 deals. Abbott's $5.3 billion buy of Alere was the biggest acquisition.
Researchers at NJIT have initially tested their biochip for the detection of early-stage ovarian cancer, but they said it could have use for other cancers and diseases.
The University of Illinois team developed the technology with an eye at low-resource settings, including developing nations and rural communities.
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.