Anne Paxton
Take a fatal and nearly untreatable cancer. Invest hundreds of millions of dollars to develop and test a drug that shrinks tumors or improves survival in half of patients with a common mutation. Link diagnosis to a PCR test that you also manufacture. And win an accelerated FDA approval for the test-drug combination.
Altogether, no mean feat. And it’s essentially what Roche accomplished to bring its metastatic melanoma drug Zelboraf (vemurafenib) on the market this year.
By all accounts, Zelboraf should bring new hope to thousands of melanoma patients and perhaps a billion dollars a year in revenue to Roche. “It’s the first ever joint FDA approval of a drug and a DNA-based companion diagnostic, and the beginning of the molecular companion diagnostics era,” says John W. Longshore, PhD, director of molecular pathology for Carolinas Pathology Group, Carolinas Medical Center, Charlotte, NC.
The FDA, in its approach to companion diagnostics, seems to favor single-assay platforms while the field moves toward multiplexed platforms, says Dr. Marc Ladanyi, here at Memorial Sloan-Kettering Cancer Center with colleagues involved in BRAF mutation testing, Maria Arcila, MD (center), and Laetitia Borsu, PhD.
Zelboraf, a kinase inhibitor, has been proven effective only for melanoma patients with the BRAF V600E mutation. But the linkage of Zelboraf to the Roche Cobas 4800 BRAF V600 Mutation Test is creating something of a furor. In its Aug. 17 approval of Zelboraf, the FDA’s Center for Drug Evaluation and Research specified that the drug is indicated “for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test” (emphasis added). So when the FDA Center for Devices and Radiological Health granted pre-market approval for the Cobas test the same day, the Roche assay became the de facto companion diagnostic for Zelboraf.
19 December 2011
Late Maj Dr. R.G.GAYER-ANDERSON DSO RAMC PASHA
Detail of the headThe sculpture is now known as the Gayer-Anderson cat after Major Robert Grenville Gayer-Anderson who donated it, together with Mary Stout Shaw, to the British Museum.[1] The statue is a representation of the cat-goddess Bastet. The cat wears jewellery and a protective wedjat amulet. The earrings and nose ring on the statue may not have always belonged to the cat.[2] While they certainly are ancient, an early photograph of the cat shows the statue wearing a different pair. A winged scarab appears on the chest and head, it is 42cm high and 13cm wide. A copy of the statue is kept in the Gayer-Anderson Museum, located in Cairo.
ConstructionThe statue is not as well preserved as it appears. X-Rays taken of the sculptire reveal that there are cracks that extend almost completely around the centre of the cats body and only an internal system of strengthening prevents the cat's head from falling off. The repairs to the cat are thought to have been carried out by Major Gayer-Anderson who was a keen restorer of antiquities in the 1930s. He is thought to have rediscovered the surface of the cat after the presumed corrosion had been removed.[3]
The cat was manufactured by the lost wax method where a wax model is covered with clay or clay and water until there is sufficient thickness. The clay can then be fired in a kiln and the wax flows out. The now hollow mould can be refilled with bronze. In this case the metal was 85% copper, 13% tin, 2% arsenic with a 0.2% trace of lead. The remains of the pins that held the wax core can still be seen using x-rays. The original metalworkers would have been able to create a range of colours on a bronze casting and the stripes on the tail are due to metal of a differeing composition. It is also considered likely that the eyes contained stone or glass decorations.[3]
[edit] References^ Description of the Gayer-Anderson Cat, British Museum
^ Oakes, Lorna, and Lucia Gahlin. Ancient Egypt: An Illustrated Reference to the Myths, Religions, Pyramids and Temples of the Land of the Pharaohs. (p. 229) Barnes & Noble, September 2003. ISBN 9780760749432.
^ a b Examination of the Gayer-Anderson cat, British Museum, accessed December 2010
[edit] Further readingClutton-Brock, J. The British Museum book of Cat. London: The British Museum Press, 2000.
Warner, Nicholas. Guide to the Gayer-Anderson Museum, Cairo. Cairo: Press of the Supreme Council of Antiquities, 2003.
Dr.Gayer-Anderson donated his Cairo home to the Egyptian Government. King Farouk awarded him the Title of PASHA.
Returned to WATERBEACH near Cambridge. Son John; a Ceramic artist.
ConstructionThe statue is not as well preserved as it appears. X-Rays taken of the sculptire reveal that there are cracks that extend almost completely around the centre of the cats body and only an internal system of strengthening prevents the cat's head from falling off. The repairs to the cat are thought to have been carried out by Major Gayer-Anderson who was a keen restorer of antiquities in the 1930s. He is thought to have rediscovered the surface of the cat after the presumed corrosion had been removed.[3]
The cat was manufactured by the lost wax method where a wax model is covered with clay or clay and water until there is sufficient thickness. The clay can then be fired in a kiln and the wax flows out. The now hollow mould can be refilled with bronze. In this case the metal was 85% copper, 13% tin, 2% arsenic with a 0.2% trace of lead. The remains of the pins that held the wax core can still be seen using x-rays. The original metalworkers would have been able to create a range of colours on a bronze casting and the stripes on the tail are due to metal of a differeing composition. It is also considered likely that the eyes contained stone or glass decorations.[3]
[edit] References^ Description of the Gayer-Anderson Cat, British Museum
^ Oakes, Lorna, and Lucia Gahlin. Ancient Egypt: An Illustrated Reference to the Myths, Religions, Pyramids and Temples of the Land of the Pharaohs. (p. 229) Barnes & Noble, September 2003. ISBN 9780760749432.
^ a b Examination of the Gayer-Anderson cat, British Museum, accessed December 2010
[edit] Further readingClutton-Brock, J. The British Museum book of Cat. London: The British Museum Press, 2000.
Warner, Nicholas. Guide to the Gayer-Anderson Museum, Cairo. Cairo: Press of the Supreme Council of Antiquities, 2003.
Dr.Gayer-Anderson donated his Cairo home to the Egyptian Government. King Farouk awarded him the Title of PASHA.
Returned to WATERBEACH near Cambridge. Son John; a Ceramic artist.
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