In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Cholestech's lipid and liver function test launched in the US:

This article was originally published in Clinica

Executive Summary

Hayward, California-based Cholestech is rolling out its Lipid Profile ALT test cassette in the US after the FDA granted CLIA waived status for the product, a test for liver function. The device enables healthcare providers to test a patient's lipid profile and alanine aminotransferase (ALT) levels simultaneously, giving results within five minutes. ALT is the most common marker for liver damage. The test can be performed in the doctor's office lab with just a single fingerstick. It is designed to allow doctors to monitor the patient's use of certain drugs, particularly statins, though lipid and liver monitoring are recommended when using a variety of other prescription drugs. Tests are performed before treatment initiation to establish a baseline level and periodically thereafter to help determine the appropriate therapeutic course of action.

You may also be interested in...

FDA Slacking In NDI Notification Enforcement; COVID-19 'Is Not An Excuse’ – NPA

In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.

Finance Watch: Four IPOs In One Week, And Legend Is Year’s Largest So Far

Public Company Edition: Legend Biotech raised $424m in its US public market debut. Also, Pfizer commits up to $500m for equity investments and Allogene capitalizes on ASCO with a $550m offering.

FDA Says GMP Lapses In Facilities And Production Areas More Common For Cell And Gene Therapies

US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts