NEW YORK, Sept. 24 – Alpha Therapeutic said it has received US Food and Drug Administration approval to use polymerase chain reaction technology to screen plasma donations for HIV-1 and hepatitis C.
The company, which made the announcement Friday, said it was the first company to receive such approval.
The National Genetics Institute, a subsidiary of Laboratory Corporation of America Holdings, developed the method, while Alpha holds the patent to a key algorithm. NGI develops PCR-based methods for testing blood borne infectious agents.
Alpha, a maker of plasma derived products, said that unlike current tests that detect either antigens or antibodies, PCR would enable the detection of ribonucleic acids contained in the virus itself. This would mean that the viruses could be detected earlier in the process of infection, when the virus is easier to tackle.
In clinical studies Alpha of Los Angeles said it demonstrated that its testing method was capable of detecting HIV-1 up to four days earlier than traditional tests and hepatitis C up to 57 days earlier than other testing methods.
Alpha holds a patent for an algorithmic method that when used with PCR can detect viruses in up to 512 pooled samples of plasma. If a sample pool tests positive, the algorithm is applied to determine the order of further testing, so that positive samples in the pool can be identified with a minimum of 26 tests, rather than the 512 tests needed to screen each sample individually, the company said.
Alpha collects plasma and turns it into products such as intravenous immune globulin for primary immune deficiencies, coagulation factors for hemophilia, and albumin for shock, burns and trauma. All of its testing is conducted by the NGI.