The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
Recently validated on pseudomonas and TB samples, the business card-sized device also enables on-chip extraction.
Hologic said that HCV therapeutic options are evolving rapidly, and the approval will enable physicians to quickly decide on the best treatments.
The tests are twice as fast as the firm's Xpert line and run on Cepheid's flagship GeneXpert system.
Both companies plan to offer the test to researchers and clinicians to help better determine when a patient can be diagnosed with an infectious disease.
The new filing comes after the firm recently withdrew plans last month to raise $8 million.
The funds, which the company said are part of a larger $9 million Series A round, will support the development of its test for early diagnosis of Lyme disease.
The three-hour PCR-based test looks for several serovars recommended for detection by the WHO, the firm said.
The selective whole-genome amplification approach was successfully adapted to Plasmodium vivax, a parasite that is notoriously difficult to culture.
The firm will apply its qPCR-enabling technology to detection kits for highly polymorphic regions of HIV that confer resistance to protease inhibitors.
As part of a restructuring and cost reduction plan the firm also reduced the principle of its 2016 convertible note by about half.
The firm's molecular revenues rose 72 percent during the fourth quarter and 75 percent during full-year 2016.
Funded by a $600 million gift, the Biohub will support investigators at three universities as well as two initial internal projects.
The firm reported that revenues for Nanosphere, which Luminex acquired in 2016, were up 39 percent year-over-year.
The firm recently won an NIH grant to develop its instrument-free gonorrhea test, and is also developing a chlamydia assay with the long-term goal of making a combined CT/NG test.
The sweep became more common in Anopheles funestus mosquitoes in Malawi and Mozambique after increased vector control efforts.
The test will be developed in Global Good labs and ported onto QuantuMDx's handheld molecular platform.
The firm said it continues to see strong growth in BD Max, and has plans to launch an extended enteric bacterial panel in the US later this year.
The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November.
The firm reported continued strength for MDx product sales across its women's health business and an overall return to growth in international sales.
An opinion piece in the New York Times urges lawmakers to keep genetic protections in place.
Research funding in Canada is to remain mostly the same, ScienceInsider reports.
In Science this week: random DNA replication errors play role in cancer, and more.
The Bill and Melinda Gates Foundation embarks on an open-access publishing path.