Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
The funding totals up to $5.6 million over five years and will incorporate Talis' proprietary SlipChip technology.
The effort will provide individuals with genetic testing to determine if they have the disorder, and when necessary, with genetic testing counselling.
The firm said that the decline was due to a customer shifting to internalizing genetic ordering, adverse weather, and the loss of an undisclosed commercial payor.
Selected companies developing innovative technologies and products could receive breakthrough device designation and greater access to FDA guidance.
Under the agreement, the companies plan to develop a customized solution that can be widely deployed for DNA sequencing.
Quest, the largest private, independent medical laboratory in Singapore, will now be able to offer Lucence's menu of liquid biopsy tests to its patients.
The tests have received coverage decisions from a number of Blue Cross Blue Shield plans this year including ones in California and New Jersey.
Cooper took a $24.4 million impairment charge in the second quarter on the intangible assets it acquired in 2016 from carrier screening firm Recombine.
The Swedish molecular diagnostics firm will use the proceeds, in part, to fund the planned launch of its Immray PanCan-d assay for detecting pancreatic cancer.
Alere received clearance for the Afinion HbA1c Dx and for the Alere i Strep A 2, a rapid molecular test for the qualitative detection of Streptococcus pyogenes.
A new trial has compared the two most prominent tests, showing that both have clear predictive ability, but leaving several other questions unanswered so far.
The company will work with medical faculties of the universities of Greifswald and Rostock to develop Dx tools for personalized, immune-based treatments.
The designation will help the company accelerate the process of bringing the opioid addiction risk test through regulatory review and clearance.
Since purchasing the bioscience unit of Sequenom four years ago, Agena has followed global growth by pushing into more clinical labs in China, as well as Europe.
The agreement grants MDxHealth the rights to manufacture and market the phosphodiesterase-4D7 biomarker as a prognostic test.
The Dutch multinational is now on track to introduce a kitted version of the assay, which can be run on standard quantitative PCR equipment, by the end of the year.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
The firm sold about about 7 million shares of its common stock at $7.50 per share, including 915,000 shares to the offering’s underwriters also for $7.50 per share.
The partners will develop next-generation sequencing-based tests for precision cancer treatment for the Asian market.