23:40 , Jan 25, 2019 |  BioCentury  |  Politics, Policy & Law

101 problems with patent eligibility

The U.S. diagnostics industry is being strangled, and other life science inventions are being hobbled by, ill-conceived and contradictory patent policies. The USPTO director has signaled he wants to help, but only Congress has the...
00:24 , Aug 3, 2018 |  BioCentury  |  Finance

Appetite for Omniome

An experienced team and a growing DNA sequencing market in China enabled San Diego’s Omniome Inc. to raise a $60 million series B round led by Chinese investors. Decheng Capital and Hillhouse Capital Group co-led...
07:00 , Oct 24, 2016 |  BC Week In Review  |  Clinical News

Harmony Prenatal Test regulatory update

Roche received CE Mark approval for the second-generation Harmony Prenatal Test to screen for Down syndrome and other chromosomal disorders. The test is a non-invasive prenatal multiplex assay that detects fetal trisomies 13, 18 and...
07:00 , Sep 16, 2016 |  BC Extra  |  Company News

Management tracks

EMA said Head of International Affairs Emer Cooke will leave the agency to join the World Health Organization as head of regulation of medicines and other health technologies in WHO's essential medicines and health products...
07:00 , Jul 11, 2016 |  BC Week In Review  |  Company News

Natera, Sequenom, Thermo Fisher, Roche diagnostic news

The U.S. Supreme Court declined to review a lower court decision invalidating U.S. Patent No. 6,258,540 covering prenatal diagnosis with nucleic acid analysis used in Sequenom’s MaterniT21 Plus laboratory-developed test. Sequenom had asked SCOTUS to...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Company News

Sequenom, Roche diagnostic news

The U.S. Court of Appeals for the Federal Circuit (CAFC) denied Sequenom’s petition for en banc re-hearing of a June 2015 decision to uphold a 2014 district court ruling that U.S. Patent No. 6,258,540 covering...
07:00 , Jun 22, 2015 |  BC Week In Review  |  Company News

Sequenom, Roche diagnostic news

The U.S. Court of Appeals for the Federal Circuit (CAFC) upheld a lower court judgment that U.S. Patent No. 6,258,540 covering prenatal diagnosis using nucleic acid analysis used in Sequenom’s MaterniT21 Plus laboratory-developed test (LDT)...
07:00 , Apr 13, 2015 |  BC Week In Review  |  Clinical News

Harmony Prenatal Test: Clinical trial data

The blinded, international NEXT trial in 15,841 evaluable pregnant women who presented for aneuploidy screening at 10 to 14 weeks of gestation showed that the Harmony Prenatal Test detected 100% of trisomy 21 cases vs....
08:00 , Jan 5, 2015 |  BC Week In Review  |  Company News

Ariosa Diagnostics, Roche deal

Roche acquired diagnostics provider Ariosa for an undisclosed sum. The companies declined to disclose financial details. Ariosa’s Harmony Prenatal Test is a non-invasive prenatal multiplex assay that detects fetal trisomies 13, 18 and 21 in...
02:50 , Dec 3, 2014 |  BC Extra  |  Company News

Roche acquires Ariosa Diagnostics

Roche (SIX:ROG; OTCQX:RHHBY) acquired Ariosa Diagnostics Inc. (San Jose, Calif.) for an undisclosed sum. Ariosa makes the Harmony Prenatal Test , a non-invasive prenatal multiplex assay that detects fetal trisomies 13, 18 and 21 in...